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3. Results | PMC10637569 | |||
3.1. Participants | cedar pollinosis | Ninety-one people consented to inclusion after explanation of this study, all of whom lived nearby. Eleven people were excluded because they did not meet inclusion criteria. Forty healthy subjects were allocated to placebo (n = 21) and probiotics groups (n = 19), and forty patients with Japanese cedar pollinosis were a... | PMC10637569 | |
3.3. Plasma JCP-specific IgE | JCP | In Japan, JCP are released into the air during the spring, and the peak of this release is in March and April. This trial was begun from late January to early February. The average JCP abundance in air was 4.1/mConcentration of serum JCP-specific IgE relative to baseline are shown in Table Concentration of serum JCP-sp... | PMC10637569 | |
3.4. Change of allergic rhinitis symptoms during JCP season | allergic rhinitis | ALLERGIC RHINITIS | To evaluate improvement of allergic rhinitis symptoms in probiotics, we analyzed the change of scores in severity of allergic rhinitis symptoms from the start to all observation points. The severity of allergic rhinitis symptoms relative to baseline are shown in Table The severity of allergic rhinitis symptoms (relativ... | PMC10637569 |
3.5. Effect of probiotics on intestinal flora | To evaluate the effect of probiotics in intestinal flora, we analyzed the fatty acids and organic anions, which were metabolites of intestinal bacteria. Short-chain fatty acids and organic anions in stools relative to baseline are shown in Table Short-chain fatty acid and organic anions in stool (relative to baseline).... | PMC10637569 | ||
3.6. Effect of probiotics on psychological conditions | mood disturbances, TMD, mood disturbance | We monitored the psychological conditions of all subjects in the trial using the POMS2 questionnaire to evaluate the condition of anger-hostility (AH), confusion-bewilderment (CB), depression-dejection (DD), fatigue-inertia (FI), tension-anxiety (TA), vigor-activity (VA), friendliness (F), and total mood disturbances (... | PMC10637569 | |
3.7. Post hoc analysis in relation to occupation ratio to | nasal blockage | Analysis of intestinal flora indicated that the occupation ratio of Changing occupation ratio of In this study, the symptom of nasal blockage was improved by NTM048 12 weeks after the start of trial. The changes of occupation ratio were affected by NTM048 for 16 weeks. The changes of occupation ratio could therefore be... | PMC10637569 | |
4. Discussion | cedar pollinosis, allergy, nasal blockage, JCP, eczema | ALLERGY, ECZEMA | This randomized, double-blinded, placebo-controlled trial examined whether a probiotic, NTM048, increased the amount of s-IgA in saliva of adults who took an oral dose for 16 weeks during the period when JCP are most scattered in the air in Japan. In the current study, there was no promotion of secretion of s-IgA in sa... | PMC10637569 |
Acknowledgments | We acknowledge editing and proofreading by Benjamin Phillis from the Clinical Study Support Center at Wakayama Medical University. | PMC10637569 | ||
Supplementary Material | PMC10637569 | |||
Abbreviations: | Yamagishi N | colony forming unitJapanese cedar pollenProfile of Mood States 2nd Editionsecreted IgAThe datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.Supplemental Digital Content is available for this article.The study was supported by funding fro... | PMC10637569 | |
References | PMC10637569 | |||
Subject terms | stroke, cardioembolic stroke, ischemic stroke, Parkinson’s disease, CAD, PD, MR | STROKE, ISCHEMIC STROKE, DISEASES, CORONARY ARTERY DISEASE, CAD | Parkinson’s disease (PD) and cardio-cerebrovascular diseases are related, according to earlier studies, but these studies have some controversy. Our aim was to assess the impact of PD on cardiocerebrovascular diseases using a Mendelian randomization (MR) method. The data for PD were single nucleotide polymorphisms (SNP... | PMC10665329 |
Introduction | Parkinson’s disease, PD | DISEASES | Parkinson’s disease (PD) is one of the most common senile diseases | PMC10665329 |
Methods | PMC10665329 | |||
Mendelian randomization data and process | PD, cardio-cerebrovascular diseases | To investigate the causal link between PD and cardio-cerebrovascular diseases, we used a two-sample MR research. Figure Flow chart of Mendelian stochastic analysis, The study satisfies the three main assumptions of Mendelian randomization: Assumption 1: The solid line indicates that the instrumental variants directly a... | PMC10665329 | |
Instrumental variables selection | The SNPs included in the study must meet the three main hypotheses of MR: (i) genetic variation is strongly associated with exposure (correlation hypothesis); (ii) genetic variation is independent of known or unknown confounders (independence hypothesis); (iii) genetic variation is only associated with the outcome of e... | PMC10665329 | ||
SNPs associated with PD | The PD-related SNPs were selected from the publicly available GWAS database from International Parkinson’s Disease Genomics Consortium, which included data from a total of 482,730 European individuals, with 33,647 in the ncase group and 449,056 in the ncontrol group | PMC10665329 | ||
SNPs associated with cardio-cerebrovascular diseases | cardio-cerebrovascular diseases, HF, artery stroke, stroke, cardioembolic stroke, ischemic stroke, CAD, heart failure | ATRIAL FIBRILLATION (AF), STROKE, ISCHEMIC STROKE, HEART FAILURE, CORONARY ARTERY DISEASE, CAD | The cardio-cerebrovascular diseases included in the study were coronary artery disease (CAD), myocardial infarction(MI), atrial fibrillation (AF), heart failure (HF), stroke, ischemic stroke (IS), large artery stroke (LAS), cardioembolic stroke (CES). We show the outcome data in detail in Table The basic characteristic... | PMC10665329 |
Mendelian randomization analysis | PD, MR, cardio-cerebrovascular diseases | To determine whether there is a causal association between PD and cardio-cerebrovascular diseases, we mostly employ the inverse variance weighted (IVW) approach for MR analysis. An IVW estimate is a measure of the combined overall effect size of Wald ratio estimates for individual SNPs. The IVW method is highly effecti... | PMC10665329 | |
Sensitivity analysis | To analyze horizontal pleiotropy, the intercept for MR-egger analysis was employed, and the test’s intercept does exist (The results of the MR sensitivity analysis. | PMC10665329 | ||
Ethics statement | Ethical review and approval are not required for research with human participants per local legislation and institutional requirements. Written informed consent to participate is not required for this study in accordance with national legislation and institutional requirements. | PMC10665329 | ||
Results | PMC10665329 | |||
Results of the two-sample mendelian randomization analysis | PD, CAD, stroke | STROKE, CAD | In the analysis, we used 23 SNPs that had substantial associations with PD (By utilizing the merging tool to find 20 SNPs in the CADs GWAS data, we then eliminated two palindromic SNPs (rs10451230, rs823106) so that only 18 SNPs were included in the final MR analysis. According to our primary IVW analysis, PD is linked... | PMC10665329 |
Reverse Mendelian randomization analysis | stroke, CAD, PD | STROKE, CAD | We used reverse MR to see if there was a known causal association between CAD, stroke, IS, CES, and PD. The results of the IVW analyses suggested that there was no causal relationship between CAD (OR = 0.969, 95% CI 0.903–1.039,Forest plot for reverse MR detection.We performed a sensitivity analysis on the results of t... | PMC10665329 |
Discussion | stroke, Alzheimer’s disease, PD, CAD, Lewy body diseases, Lewy | CVD, STROKE, LEWY BODY DISEASE, DISEASES, PATHOGENESIS, CAD | Our study reveals a potential relationship between PD and CAD and stroke (including subtypes IS, CES), which is consistent with the results of previous small cohort studies, but past cohort studies were smaller and had a lower level of evidencePD is the second most common neurodegenerative condition after Alzheimer’s d... | PMC10665329 |
Supplementary Information | The online version contains supplementary material available at 10.1038/s41598-023-47708-2. | PMC10665329 | ||
Acknowledgements | We thank researchers such as Ishigaki K, Nielsen JB, Shah S, CARDIoGRAMplusC4D Consortium, MEGASTROKE Consortium, for providing the publicly available GWAS data for this study. | PMC10665329 | ||
Author contributions | Z.Z. and J.H. designed the methods and carried out the statistical analyses. Z.Z., M.Z., and Q.F. made substantial contributions to the acquisition and analysis of the data and the interpretation of data. All the authors contributed to the data extraction, drafted the article, and approved the final version of the manu... | PMC10665329 | ||
Funding | The study was supported by grants from the National Natural Science Foundation of China (Grant Nos. 82170445). | PMC10665329 | ||
Data availability | PD | DISEASES | The original contribution presented in this study is included in the article/supplementary material, further inquiries can be made to the corresponding author. All the datasets related to PD and cardio-cerebrovascular diseases are freely available from IEU OpenGWAS project, the link for PD is ( | PMC10665329 |
Competing interests | The authors declare no competing interests. | PMC10665329 | ||
References | PMC10665329 | |||
KEYWORDS | PMC10269629 | |||
INTRODUCTION | hyperlipidemia | HYPERLIPIDEMIA | The rapid development of the world economy has dramatically changed people's living standards and diet structure, and the fast-food diet structure has also led to an obvious increase in the proportion of high-fat foods in the daily diet (Several studies have found a link between hyperlipidemia and human gut microbiota,... | PMC10269629 |
RESULTS | PMC10269629 | |||
Probio-X improved blood lipid indexes in a hyperlipidemia population. | hyperlipidemia | HYPERLIPIDEMIA | Body weight, height, and work employment were collected and analyzed (Information of patientsThere were no significant differences in all blood biochemistry between the placebo and probiotic groups at baseline. The blood analysis of hyperlipidemic patients showed that the total cholesterol (TC) and low-density lipoprot... | PMC10269629 |
Probio-X improved dietary and exercise habits in hyperlipidemic patients. | hyperlipidemia | REMISSION, HYPERLIPIDEMIA | A self-administered questionnaire was applied to record the dietary and exercise habits of the hyperlipidemic patients during the trial intervention. We thus analyzed changes in dietary and exercise habits in patients showing improvements in TC, LDL-C, and HDL-C. Interestingly, patients in the probiotic group that show... | PMC10269629 |
Changes in patients’ fecal microbiota after Probio-X intervention. | HYPERLIPIDEMIA | Although numerous studies in recent years have observed a strong association between the gut microbiota and onset/progression of hyperlipidemia, our microbial alpha diversity analysis (Shannon and J indexes) of subjects’ fecal microbiota revealed no significant intra-/intergroup differences (paired Wilcoxon test, Chang... | PMC10269629 | |
Changes in patients’ serum lipid profile after Probio-X intervention. | ’ lipid blood metabolic | It is known that gut microbiota interacts with the host metabolism and influences the blood metabolome. Therefore, patients’ lipid blood metabolic profile was analyzed by principal-component analysis (Changes in serum lipid profile after Probio-X intervention. (A and B) Principal-component analysis of serum lipid metab... | PMC10269629 | |
Changes in predicted gut metabolites after Probio-X intervention. | hyperlipidemia | HYPERLIPIDEMIA | The probiotic treatment did not seem to drastically modulated patients’ fecal microbiota structure and composition; thus, we further investigated the mechanisms of regulation of hyperlipidemia by analyzing probiotics-driven changes in predicted gut metabolites from the MAGs. A total of 41 gut metabolites were predicted... | PMC10269629 |
DISCUSSION | asthmatic, dyslipidemia, hyperlipidemia | ASTHMATIC, HIGH TRIGLYCERIDES, DYSLIPIDEMIA, HYPERLIPIDEMIA | Gut microbiota are associated with the host metabolism and may influence the onset and development of hyperlipidemia (Our data supported that the intake of the probiotic mix could effectively reduce the serum levels of TC and LDL-C, while increasing serum HDL-C levels, in patients with hyperlipidemia. Such results supp... | PMC10269629 |
Conclusions. | HYPERLIPIDEMIA | We performed a 3-month intervention trial and confirmed the beneficial effects of application of a probiotic mix in alleviating hyperlipidemia, at least in part, by regulating the blood lipid indexes (lowering serum TC, LDL-C, and HDL-C), lipid metabolism, and gut microbiota. Although insignificant changes were observe... | PMC10269629 | |
MATERIALS AND METHODS | PMC10269629 | |||
Probiotic administration. | Probio-X (3 × 10 | PMC10269629 | ||
Trial design and subject recruitment. | diabetes, cancer, kidney disease, mental illness, hyperlipidemia | DIABETES, GASTROINTESTINAL DISEASES, DISEASES, HYPERLIPIDEMIA | This study was a 3-month randomized controlled double-blind trial. A total of 112 patients with hyperlipidemia were recruited. All patients were recruited by the Inner Mongolia People's Hospital and Inner Mongolia Agricultural University. The inclusion criteria were as follows: (i) male or female aged between 18 and 65... | PMC10269629 |
Collection and processing of stool and blood samples. | STERILE | The study was conducted for 3 months, and feces and blood were collected from all participants at days 0 and 90 after the start of the study. Stool samples were self-collected by each subject at the specified time point at home using a uniformly provided sterile stool sampler with DNA protection solution (Guangdong Lon... | PMC10269629 | |
Analysis of biochemical indicators. | TG | BLOOD | Blood samples were used for monitoring physiological and biochemical changes in the subjects. The analyzed physiological/biochemical parameters mainly focused on lipid metabolism, namely, LDL-C, TC, HDL-C, high-sensitivity C-reactive protein [hsCRP], fasting serum glucose, TG, serum uric acid, diamine oxidase, | PMC10269629 |
Statistical analysis and data visualization. | All statistical analyses were performed using the R software (v 4.0.3), and data were expressed as mean ± SD. Wilcoxon test and | PMC10269629 | ||
ACKNOWLEDGMENTS | This research was supported by the Inner Mongolia Science and Technology Major Projects (2021ZD0014), the National Natural Science Foundation of China (31720103911), the Health Science and Technology Planning Project of Inner Mongolia (202202026), and the earmarked fund for CARS36.We declare no conflicts of interest. | PMC10269629 | ||
REFERENCES | PMC10269629 | |||
Background | HIV antibody, infectious disease, acute HIV infection, HIV (PWH | INFECTIOUS DISEASE, ACUTE HIV INFECTION, DISEASE, SECONDARY | Integration of a sensitive point-of-care (POC) HIV viral load (VL) test into screening algorithms may help detect acute HIV infection earlier, identify people with HIV (PWH) who are not virally suppressed, and facilitate earlier referral to antiretroviral therapy (ART), or evaluation for pre-exposure prophylaxis (PrEP)... | PMC10474693 |
Methods | PWH | The study will recruit people 18 years or older who have risk factors for HIV acquisition and are not on PrEP, or PWH who are not taking ART. Participants will be randomly assigned to either the control arm or the intervention arm. Participants randomized to the control arm will only receive the standard-of-care (SOC) ... | PMC10474693 | |
Discussion | The EHPOC trial will explore a novel HIV diagnostic technology that can be performed at the POC and provide viral assessment. The study may help inform HIV testing algorithms and contribute to the evidence to support same day ART and PrEP recommendations. | PMC10474693 | ||
Trial registration | NIH ClinicalTrials.gov NCT04793750. Date: 11 March 2021. | PMC10474693 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12879-023-08459-7. | PMC10474693 | ||
Keywords | PMC10474693 | |||
Background | undiagnosed infection, PWH, HIV infection, viral suppression, HIV (PWH) [A 2019, infection, human immunodeficiency virus (HIV) infection | INFECTION, HIV INFECTION | Diagnosis of acute human immunodeficiency virus (HIV) infection followed by early antiretroviral therapy (ART) initiation serves both individual and public health, as it has health benefits for the person receiving treatment [Point-of-care (POC) testing which is defined as near-patient testing performed at home, clinic... | PMC10474693 |
Objectives | The primary objective of this trial is to evaluate whether the use of a POC HIV VL test, in addition to SOC HIV testing, for HIV screening increases the proportion of persons linked to ART or PrEP. Secondary objectives are: [ | PMC10474693 | ||
Methods/design | ® | Ending the HIV Epidemic Through Point-of-Care Technologies (EHPOC) is an unblinded randomized clinical trial that will compare a standard-of-care (SOC) HIV testing algorithm to the SOC algorithm with the addition of POC HIV screening with the Xpert® HIV-1 VL test (Cepheid, Sunnyvale, CA). | PMC10474693 | |
Study sites | INFECTIOUS DISEASES, EMERGENCY | Sites planned as part of the study are the Johns Hopkins Hospital Emergency Department (JHHED), the Johns Hopkins Bayview Medical Center, the John G. Bartlett Specialty Practice (JGBSP) Infectious Diseases Clinic, and the Baltimore City Health Department (BCHD) Sexual Health Clinics, all located in a high HIV burden ar... | PMC10474693 | |
Recruitment, consent, and randomization | After identification by study coordinators, a clinician will ask potential participants if they are interested or willing to participate in the study. Those who are interested in the study will be introduced to a research coordinator to discuss the study and assess eligibility. Those who do not agree to participate wil... | PMC10474693 | ||
Participant removal criteria | Participants may withdraw voluntarily from study participation at any time and those who do not complete all study procedures at enrollment (e.g., do not have blood drawn during visit) will be classified as early withdrawals. Participants who withdraw will continue their care with the appropriate clinical service. | PMC10474693 | ||
Enrollment visit | ®, HIV, human immunodeficiency virus, HIV antibody tests- 20, human immunodeficiency virus, TATHIV, ® HIV combi | EVENTS, DISEASE, HUMAN IMMUNODEFICIENCY VIRUS | At the enrollment visit, study participants in both arms will provide blood and oral fluid specimens for HIV testing. The sequence for enrollment visit procedures is presented in Fig.
OraQuick ADVANCEDPPElecsysGeenius
Sequence for enrollment visit procedures in the EHPOC study, Baltimore, MD, 2023–2024Abbreviations: C... | PMC10474693 |
Week-4 and week-12 visits | All participants will be followed-up post enrollment (Table | PMC10474693 | ||
Discordant result visits | ® HIV combi, ® | HIV INFECTION, EVENTS | Participants who have discordant results between (a) the POC HIV VL test or (b) the rapid HIV tests compared with the laboratory-based HIV tests will be offered additional study follow-up visits to evaluate the sensitivity of different HIV tests for detection of early HIV infection.The participants with discordant resu... | PMC10474693 |
Follow up after the enrollment clinic visit and test results | HIV infection | HIV INFECTION, DISEASE, PCP | Within 24 h of results being available, research coordinators will communicate HIV test results to the participants and share the results with the participant’s primary care provider. Key clinical decisions that are impacted by having the results of the POC HIV VL test will be recorded based on participant interviews a... | PMC10474693 |
Specimen and data collection | ADVERSE EVENTS, EVENTS | Two biospecimens will be collected: oral (swab and fluid), and blood via venipuncture. The research coordinators will be trained in phlebotomy by the ICTR and follow Good Clinical Practice (GCP). In addition, trained phlebotomists will be available for venipuncture for participants attending the CRU. Samples will be tr... | PMC10474693 | |
Outcome measures | PWH | SECONDARY | The primary outcome for this trial is the proportion of participants that are linked either to ART or PrEP. Linkage is defined as having at least one interaction (a telehealth or in-person conversation about HIV PrEP or ART) with a healthcare provider during the 12-week follow up period after enrollment. After the Week... | PMC10474693 |
Power calculation and analysis plan | POC HIV VL | REGRESSION | Using data from prior studies, we observed an LTC rate of 22% for the JHHED patients who are living with HIV but not in care or who are HIV-negative and PrEP-eligible, and an LTC rate of 50% for PrEP-eligible patients attending STI services or recruited via social media, resulting in an overall aggregate LTC rate of 32... | PMC10474693 |
Reporting unanticipated problems or study deviations | ADVERSE EVENT | Any protocol deviation or adverse event that meets reporting requirements of the Institutional Review Board (IRB) will be reported to the Johns Hopkins IRB, and a de-identified report will be submitted to the CDC. All deviations from the protocol will be addressed in the study participant source documents. The document... | PMC10474693 | |
Benefits of participation | infection | INFECTION | Participants may benefit from earlier diagnosis of HIV, which should facilitate earlier treatment and avoidance of the sequalae of untreated infection. Participants will have the opportunity to learn more about their sexual health and will be referred for rapid initiation of HIV treatment and prevention services, as we... | PMC10474693 |
Discussion | PWH, POC HIV VL, HIV infection, acute HIV infection, EHE, HIV infections | HIV INFECTIONS, HIV INFECTION, ACUTE HIV INFECTION | This clinical trial may demonstrate that HIV testing algorithms using a POC HIV VL screening test has the potential to facilitate same-day initiation of ART or PrEP and improve the diagnosis of acute HIV infection, which may be missed using existing HIV testing algorithms. Detection of acute HIV infection is especially... | PMC10474693 |
Trial Status | RECRUITMENT | Recruitment of participants is planned to begin in Spring, 2023. | PMC10474693 | |
Acknowledgements | We acknowledge in-kind contribution (non-monetary support); Roche Diagnostics and Cepheid have agreed to provide test kits (cartridges) for this study. | PMC10474693 | ||
Authors’ contributions | SE, KPD, HHM | HHM | MMH and YCM formulated the research question, and designed the study. MHB authored the first draft of the manuscript. YHH devised the data analysis plan. MHB, TS, AB, and CP oversaw the collection of clinical data. MMH, YCM, RER, YHH, SE, HHM, PRC, BE, NGJ, KPD, DD, and RJM contributed to study design. MMH, YCM, AM, an... | PMC10474693 |
Funding | Funding for this clinical trial is provided by the CDC. The current study protocol was designed in collaboration with the CDC. Grant number: U01PS005204-01-00. | PMC10474693 | ||
Data Availability | Not applicable. | PMC10474693 | ||
Declarations | PMC10474693 | |||
Competing interests | SE, KPD, HHM | HHM | HHM has research collaborations with Roche and Bio-Rad and serves on the advisory board for SeeGene. YCM has received research grant support to Johns Hopkins University from Hologic, Cepheid, Roche, ChemBio, Becton Dickinson, miDiagnostics, and has provided consultative feedback to Abbott on one occasion. MMH has recei... | PMC10474693 |
Ethics approval and consent to participate | All study procedures will be performed in accordance with the relevant guidelines and regulations of the Declaration of Helsinki. Study participants will only engage in research activities after providing signed informed consent. The informed consent process will include the research coordinators explaining all study p... | PMC10474693 | ||
Consent for publication | Not applicable. | PMC10474693 | ||
Disclaimer | DISEASE | The findings and conclusions in this manuscript are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention. | PMC10474693 | |
Abbreviations | TRANSMITTED, DISEASE, EMERGENCY, IMMUNODEFICIENCY | AntibodyAntigenAnti-Retroviral TherapyThe Baltimore City Health DepartmentControl armCaliforniaConfidence IntervalCenters for Disease Control and PreventionClinical Research UnitDisease Intervention SpecialistEthylenediamine Tetraacetic AcidEnding the HIV EpidemicEnding the HIV Epidemic Through Point-of-Care Technologi... | PMC10474693 | |
References | PMC10474693 | |||
Background | infection | RESPIRATORY INFECTIONS, INFECTION | Coughing caused by tracheal extubation is common following general anaesthesia. Heavy aerosol production by coughing during recovery from general anaesthesia in patients with respiratory infections (especially COVID-19) may be one of the highest risk factors for infection in healthcare workers. The application of local... | PMC9807976 |
Methods | postoperative pharyngeal pain, agitation, postoperative cough | Patients scheduled for laparoscopic cholecystectomy or cholecystectomy combined with common bile duct exploration under general anaesthesia were randomly assigned to Group C (saline spray), Group L (2 g compound lidocaine/prilocaine cream contains 5 mg of lidocaine and 5 mg prilocaine)), Group T (tetracaine) and Group ... | PMC9807976 | |
Results | cough | A total of 211 patients were randomly assigned to Group C (53 cases), Group L (52 cases), Group T (52 cases) and Group F (54 cases). The primary result is assessment of the incidence of cough. The patients emerged from general anaesthesia, 96% of Group C had cough, which was significantly reduced in Group L (61.5%, | PMC9807976 | |
Conclusions | respiratory infectious diseases | Compound lidocaine/prilocaine cream combined with tetracaine may be a more effective approach for preventing coughing and stabilising circulation during extubation following general anaesthesia. This may play an important role in preventing medical staff from contracting respiratory infectious diseases. | PMC9807976 | |
Trial registration | Chinese Clinical Trial Registry: ChiCTR2200058429 (registration date: 09–04-2022) “retrospectively registered”. | PMC9807976 | ||
Keywords | PMC9807976 | |||
Introduction | Coughing caused by endotracheal tubes in general anaesthesia is one of the most common reflexes in clinical medicine, especially when the trachea is extubated and the incidence is between 38 and 96% [ | PMC9807976 | ||
Methods | PMC9807976 | |||
Trial design | The Affiliated Hospital of Yan’an University, China organised this RCT. The trial was performed according to the CONSORT-2010 guidelines. The Ethics Committee of The Affiliated Hospital of Yan’an University approved the study protocol (NO. 2020042), and all subjects provided written informed consent before participatin... | PMC9807976 | ||
Participants and setting | sore throat, intraoperative bleeding, upper respiratory tract lesions, cough, allergies, hypertension, tube tolerance cough | SORE THROAT, CHRONIC PHARYNGITIS, ALLERGIES, HYPERTENSION, INTRAOPERATIVE BLEEDING, BRONCHOSPASM | Patients were included in the trial when they were 18 ~ 64 years old and scheduled for laparoscopic cholecystectomy or cholecystectomy combined with common bile duct exploration under general anaesthesia using endotracheal tube intubation. The following major exclusion criteria were used: American Society of Anaesthesi... | PMC9807976 |
Randomisation and blinding | A total of 236 random numbers were generated by IBM SPSS Statistics 25 (IBM Corp. Released 2017. IBM SPSS Statistics for Windows, Version 25.0. IBM Corp, Armonk, NY, USA), and the software randomly divided the 236 numbers into four groups. Cases were enrolled according to the order of enrolment time corresponding to ra... | PMC9807976 | ||
Intervention | Anaesthesiologist A treated the surface of the tip of the endotracheal tube according to the random number table. In Group C, normal saline (2 ml) was evenly sprayed onto the front end of the tracheal tube up to the two black marked lines near the cuff. In Group L two grams of compound lidocaine/prilocaine cream (compo... | PMC9807976 | ||
Parameter measurement | coughing, cough, agitation, coughs, coughing reaction | The primary outcome measure was the incidence of induced coughing due to endotracheal extubation. The definition of induced cough was patients with coughing induced by extubation during recovery from anaesthesia. Secondary outcome measures were the incidence of agitation and active extubation, endotracheal tube toleran... | PMC9807976 | |
Conditions of endotracheal tube extubation | The following conditions were used for tracheal tube extubation: 1) spontaneous breathing tidal volume greater than 6 ml/kg; 2) breathing of air for at least 5 min with saturation of pulse oximetry (SPO | PMC9807976 | ||
Sample size calculation | cough | According to our previous pilot studies, the incidence of cough induced by extubation was 95% in Group C, 45% in Group L, 60% in Group T, and 15% in Group F. We set α = 0.05 and β = 0.25, with a sample drop-out rate of 15%. Using PASS 15, we calculated a minimum sample size of 59 cases in each group (a total of 236 cas... | PMC9807976 |
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