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Declarations
PMC10176668
Ethics approval and consent to participate
Informed consent form was required to be signed by the subject and caregiver or study partner before exposure to any study-related procedure, including screening tests for eligibility. The Institutional Review Board (IRB; Advarra IRB, Columbia, MD) reviewed the protocol and informed consent form. The Investigators were...
PMC10176668
Consent to publication
Not applicable.
PMC10176668
Competing interests
Nordisk, ABH, BBS, NJI, Dementia, LSS
BRAIN
Current/former employees of Cognition Therapeutics (Cognition): NJI, KML, RY, LW, MEH, SMC, AOC. Cognition paid consultants: CMY, JRC, RJG, CSD, MG, RM. LSS grants/fees: Eli Lilly, Merck, Roche/Genentech, Avraham, Boehringer Ingelheim, Neurim, Neuronix, Cognition, Eisai, Takeda, vTv, Abbott, Biogen, Novartis, Biohaven,...
PMC10176668
References
PMC10176668
Subject terms
desaturation, apnea
OBSTRUCTIVE SLEEP APNEA, EVENTS, SECONDARY, EVENT
Nasal pressure signal is commonly used to evaluate obstructive sleep apnea. This study aimed to assess its safety for respiratory monitoring during sedation. A total of 45 adult patients undergoing sedation with propofol and fentanyl for invasive endoscopic procedures were enrolled. While both nasal pressure and capnog...
PMC9871023
Introduction
overdose, airway obstruction, hypoxemia, respiratory disorder, respiratory depression
AIRWAY OBSTRUCTION, HEMODYNAMIC INSTABILITY, RESPIRATORY DISORDER, EVENTS, RESPIRATORY DEPRESSION
The upper interventional endoscopy procedures of endoscopic submucosal dissection (ESD), endoscopic retrograde cholangiopancreatography (ERCP), endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA), and double-balloon enteroscopy (DBE) are currently performed under sedation with sedative agents, including propo...
PMC9871023
Materials and methods
PMC9871023
Study population
CRF
CRF
Patients scheduled for ERCP, ESD, EUS-FNA, or DBE under sedation at Chiba University Hospital between December 2019 and April 2020 were enrolled. The inclusion criteria included age ≥ 20 years, SpOAll cases were registered centrally at the data center (Chiba University Hospital). All data were collected using case repo...
PMC9871023
Study design
This was a prospective, single-center, single-arm phase II trial to confirm the safety of the nasal pressure monitor as a novel approach to monitoring during invasive endoscopic procedures with non-anesthesiologist administration of propofol and fentanyl sedation. All patients were placed in the treatment position afte...
PMC9871023
Procedure (intervention)
respiratory abnormality, obstructive sleep apnea, respiratory abnormalities, apnea, SpOAll adverse
ADVERSE EVENTS, BLOOD, EVENTS, OBSTRUCTIVE SLEEP APNEA
All patients underwent standard monitoring with continuous pulse oximetry. Blood pressure was monitored every 2.5 min for the first 15 min and then every 5 min, and clinical observation, including the Ramsay Sedation Scale, was performed every 5 min with electrocardiogram monitoring. Bispectral Index waveforms were als...
PMC9871023
Study outcomes
desaturation
EVENTS
The primary outcome was the incidence of desaturation events, defined as a fall of SpO
PMC9871023
Statistical analysis
hypoxemia, respiratory abnormalities
REGRESSION
Using propofol-based sedation, the hypoxemia rate during invasive endoscopic procedures under sedation was reported to range from 12 to 50%Continuous data were expressed as the mean and standard deviation. Categorical data were presented as numbers and percentages. Categorical variables were compared using Fisher’s exa...
PMC9871023
Ethics statement
This study was approved by the Research Ethics Committee of the Graduate School of Medicine, Chiba University (approval number 3180015). Written informed consent was obtained from all participants.
PMC9871023
Results
PMC9871023
Analysis population
A total of 45 adult patients were assessed for eligibility, and all the patients were enrolled. Of the 45 patients, two patients dropped out before treatment: one had the procedure canceled, and the other’s respiratory waveform was not displayed from the start due to an equipment malfunction. Thus, we analyzed data fro...
PMC9871023
Primary outcome
oxygen desaturation
Of the 43 patients who underwent endoscopic treatment, 12 patients had oxygen desaturation of SpO
PMC9871023
Respiratory abnormality detectability
During treatment, oxygen desaturation of SpO
PMC9871023
Representative cases
Figure Waveform examples. Top, capnography; bottom, nasal pressure monitoring. Arrows (black) indicate the point of SpO
PMC9871023
Discussion
respiratory abnormality, obstructive disorders, respiratory abnormalities, allergies
OXYGEN DEFICIENCY, ADVERSE EVENTS, EVENT, HYPOXIC, ALLERGIES, EVENTS
In this phase II study, no major safety issues were observed with the nasal pressure monitor as a novel approach to monitoring during invasive endoscopic procedures under sedation with propofol and fentanyl. SpOOf the 45 patients, two cases dropped out: one due to the cancellation of the endoscopic procedure itself and...
PMC9871023
Supplementary Information
The online version contains supplementary material available at 10.1038/s41598-023-28213-y.
PMC9871023
Acknowledgements
We would like to thank Masayuki Yokoyama, Kosho Asano, Miyuki Sensui, Yukiko Shima, Satomi Nakamura, Ryoko Arai, and Yuka Izumi for supporting this research. This study would not have been possible without them.
PMC9871023
Author contributions
T.M., H.N.
H.N. and R.M. wrote the paper. H.N., R.M., S.I., and S.O. designed the study. R.T. and Y.S. analyzed the data. H.S., I.O., S.Y., T.M., K.K., Y.K., Y.M., M.K., S.M., and T.Y. performed endoscopy and collected the data. J.K. and N.K. supervised the study. All authors reviewed the manuscript.
PMC9871023
Funding
The authors received no specific funding for this work.
PMC9871023
Data availability
All data generated or analysed during this study are included in this published article (and its Supplementary Information files).
PMC9871023
Competing interests
Shiroh Isono is one of the inventors of the nasal pressure monitoring system tested in this study. Shiroh Isono received scholarship donations and consultant fees from Nihon Kohden Inc. The other authors declare no conflicts of interest.
PMC9871023
References
PMC9871023
Introduction
COPD
COPD, DISEASE, CHRONIC OBSTRUCTIVE PULMONARY DISEASE
Chronic obstructive pulmonary disease (COPD) is a common, preventable and treatable disease characterized by persistent and progressive restrictions on air circulationPulmonary rehabilitation (PR) is an essential component of COPD management and has been proven to improve the physical and psychological ability of patie...
PMC10739839
Methods
PMC10739839
Study design
COPD
COPD
This study adopted a quasi-experiment design (nonequivalent control group and non-synchronized, pretest–posttest design). Due to it is difficult to achieve double-blind intervention in this study, non-randomized controlled trials were selected. We used a convenient sampling method to select COPD patients in the outpati...
PMC10739839
Participants
COPD
MAY, COPD
Participants were recruited from May 2022 to July 2022. Inclusion criteria were as follows: (1) the diagnosis of stable COPD patients according to the GOLD (2022) guidelines, with a postbronchodilator ratio of the forced expiratory volume in one second (FEV1) to the forced vital capacity (FVC) < 0.70, and absence of ex...
PMC10739839
Sample size calculation
We calculated sample size based on the assumption that patients who received a behavior-change intervention improved the primary outcome (physical activity levle). Sample size was calculated using the formula: n1 = n2 = (Zα + Zβ)2 * 2σ2/δ2. The two-group sample size ratio was 1:1, statistical power of 90%, and a 2-side...
PMC10739839
Intervention
COPD
COPD, DISEASE
This study is mainly divided into two groups, experimental group and control group. Both the experimental and control groups received standard medical care provided in the hospital. The control group was given routine intervention and health education guidance, including basic knowledge of the disease, smoking cessatio...
PMC10739839
Building the intervention team
A nurse-led multidisciplinary team was established before the intervention. There were 13 members in the group, including 1 director of the nursing department, 2 head nurses, 2 chief physicians of respiratory medicine, 1 rehabilitation therapist, 4 nurses of respiratory medicine and 3 postgraduates of nursing. Among th...
PMC10739839
Develop a physical activity plan
COPD
COPD, DISEASE
At the beginning of this phase, a literature review and expert consultation were used to formulate the components and steps of the intervention. Then, combined with the disease demands of COPD patients in China, we initially constructed the first draft of a PA intervention program for COPD patients under the guidance o...
PMC10739839
Implementing the intervention
nausea, dyspnea, PA behavior, chest pain, dizziness, bad emotions, TTM, COPD
COPD, DISEASE, BEND
Motivational interviewOn the first day of admission, the nurse introduced the ward environment and the purpose of the study to the patient and her family, obtained the patient’s consent and cooperation, and signed the informed consent form. The patient’s medical history, PA status and other information related to the ...
PMC10739839
Assessments
PMC10739839
General data
COPD
COPD
The questionnaire was designed by researchers on the basis of reviewing the relevant literature. (I) Demographic data, including age, sex, weight, marital status, education level, smoking status, etc.; (II) disease-related data, including GOLD classification, year of COPD diagnosis, comorbidities, etc.
PMC10739839
International physical activity questionnaire, IPAQ
The questionnaire was developed by the World Health Organization in 1998. It includes both short and long versions and is recognized as one of the valid assessment questionnaires for measuring PA levels
PMC10739839
Pulmonary function tests
Forced vital capacity (FVC), forced expiratory volume in one second (FEV1), and the FEV1/FVC ratio were measured by a computerized spirometer. The spirometer was calibrated before use to ensure that it worked properly. Before the examination, we understood the patient’s medical history and treatment in detail, determin...
PMC10739839
Modified Medical Research Council scale (mMRC)
breathlessness, disability
The mMRC scale is a self-rating tool to measure the degree of disability that breathlessness poses on day-to-day activities on a scale from 0 (no breathlessness except on strenuous exercise) to 4 (too breathless to leave the house or breathless when dressing or undressing)
PMC10739839
Six minutes walking test, 6MWT
dyspnea, fatigue
BLOOD, THORACIC
The 6MWT was undertaken in accordance with the American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines. It was carried out by the team members in the corridor of the respiratory ward of the hospital, with a length of 30 m and red warning lines marked at both ends of the ground. Blood oxygen satura...
PMC10739839
Exercise Self-Regulatory Efficacy Scale, EX-SRES
COPD
COPD
This scale was developed by Davis et al. and can be used as an effective tool to assess exercise efficacy beliefs in COPD patients
PMC10739839
COPD assessment test, CAT
The scale was developed by Jones PW and can be used to assess the clinical symptoms and quality of life of patients
PMC10739839
Data collection
The general data and outcome indicators of this study were collected by two trained and qualified evaluators. The collection time of each indicator was as follows: (I) Baseline data: collected on the day of admission; (II) The outcome indicators included the main outcome indicators: physical activity, which was collect...
PMC10739839
Data analysis
All data were input into Excel 2017. After double-checking and verification, a database was established, and SPSS 26.0 statistical software was used for statistical analysis. To evaluate the normality of the data, the Shapiro–Wilk test was utilized. Data are presented as the mean ± standard deviation (SD) for continuou...
PMC10739839
Results
PMC10739839
Discussion
dyspnea, COPD
COPD, DISEASE, DISEASE PROGRESSION
To the best of our knowledge, this is the first study to evaluate the effect of a PA program based on BCW theory on PA levels, sedentary time, dyspnea, exercise capacity, lung function and HRQoL among patients with COPD. The results showed that, compared to the control group, the PA of patients in the experimental grou...
PMC10739839
Limitations
COPD
COPD
Considering the factors of manpower, material resources and time, there are still some limitations in this study. First, compared with experimental studies, quasi-experimental studies are more feasible and practical in population intervention research. There are several limitations associated with quasi-experimental de...
PMC10739839
Conclusions
COPD
COPD
In summary, our results showed that the BCW theory-based PA program increased PA levels, reduced sedentary time, enhanced exercise capacity and self-efficacy, and improved some lung function measures as well as HRQoL in patients with stable COPD. In the future, we can further explore the continuous effect of this progr...
PMC10739839
Supplementary Information
Supplementary Information 1.Supplementary Information 2.
PMC10739839
Supplementary Information
The online version contains supplementary material available at 10.1038/s41598-023-50099-z.
PMC10739839
Acknowledgements
COPD
COPD
We would like to thank all individuals with COPD who participated in this study and the staff who helped collect data.
PMC10739839
Author contributions
X.X.: Data curation, Data collection, Formal analysis, Writing-original draft. M.H.: Data curation, Data collection, Formal analysis. X.L. and X.L.: The study research design, Methodology, and interpretation. Y.Y: Investigation, Formal analysis. S.C.: Investigation, Formal analysis. L.H.: Conceptualization, Methodology...
PMC10739839
Funding
This work was supported by two grants from the General Public Welfare Projects of Science and Technology Department of Zhejiang Province of China (LGF20G030009). The Medical and Health Science and Technology Department of Zhejiang Province (2023KY695).
PMC10739839
Data availability
Data from this study are available on request from the corresponding author (lihuahuang818@zju.edu.cn).
PMC10739839
Competing interests
The authors declare no competing interests.
PMC10739839
References
PMC10739839
Background
blood loss
BLOOD LOSS
This randomized controlled study was undertaken to investigate the efficacy of intravenous tranexamic acid (TXA) administration in reducing perioperative blood loss in patients undergoing medial opening-wedge distal tibial tuberosity osteotomy (MOWDTO). It was hypothesized that TXA would reduce perioperative blood loss...
PMC9996975
Methods
blood loss
BLOOD LOSS
A total of 61 knees in 59 patients who underwent MOWDTO during the study period were randomly assigned to either of the groups with intravenous TXA administration (TXA group) or without TXA administration (control group). In the TXA group, patients received 1000 mg of TXA intravenously before skin incision and 6 h afte...
PMC9996975
Results
blood loss
BLOOD LOSS
The perioperative total blood loss was significantly lower in the TXA group (543 ± 219 ml vs. 880 ± 268 ml
PMC9996975
Keywords
PMC9996975
Introduction
bleeding, blood loss, varus deformity, knee osteoarthritis, DVT
BLEEDING, BLOOD LOSS, POSTOPERATIVE BLEEDING, KNEE OSTEOARTHRITIS, POSTOPERATIVE DEEP VEIN THROMBOSIS, DVT
Osteotomy around the knee is a widely employed surgical option for medial compartment knee osteoarthritis exhibiting varus deformity [As a countermeasure for postoperative bleeding, tranexamic acid (TXA) administration plays a key role in various surgical fields [With the recent trend in joint preservation and biologic...
PMC9996975
Materials and methods
PMC9996975
Study design
pulmonary embolism, allergy, knee osteoarthritis, DVT
PULMONARY EMBOLISM, ALLERGY, KNEE OSTEOARTHRITIS, DVT
This prospective, two-arm, parallel group, randomized-controlled, open-label trial with 1:1 treatment allocation was performed in a single university hospital. The study was approved by the institutional review board. (Registered on 26/02/2019, registration number 3136). Before participant enrollment, the trial was reg...
PMC9996975
Randomization
Each patient participating in the trial was randomly assigned to one of the two groups through simple random allocation. We generated randomized numbers ranging from 0 to 99 with a computer software (Excel 2010; Microsoft, Redmond, Washington, USA). Patients with even numbers were allocated to the group scheduled to re...
PMC9996975
Interventions
The study treatments were intravenous TXA administration (TXA group) or no administration of TXA (control group). In the TXA group, patients received 1000 mg of TXA diluted by 100 ml of saline intravenously (Transamin; Daiichi Sankyo, Tokyo, Japan) before skin incision and 6 h after the first dose. The patients allocat...
PMC9996975
Surgical procedure
Akiyama T
All surgical procedures were performed in a standardized manner under general anesthesia and performed by one of the four surgeons. No pneumatic tourniquet was used during the study period. The MOWDTO procedure performed in this study followed the triplane osteotomy technique described by Akiyama T [Postoperative radio...
PMC9996975
Postoperative care
postoperative thromboembolism, anemia, pain
ANEMIA
After surgery, elastic compression stockings and a mechanical compression device were applied to the lower limbs on both sides. For chemoprophylaxis for postoperative thromboembolism, 15 mg per day of edoxaban, an Xa-inhibitor, was orally administered until one week after surgery. At one week, ultrasonographic examinat...
PMC9996975
Outcome measures
PMC9996975
Primary outcome
blood loss, Hb loss
BLOOD LOSS
The primary outcome was the volume of perioperative total blood loss, which was calculated as follows.First, the blood volume of the patient was calculated in liters using the following formula according to Nadler et alSecond, Hb loss was calculated according to the following formula.Finally, the total blood loss was c...
PMC9996975
Secondary outcomes
pain, DVT
SECONDARY, SOFT TISSUE INFECTIONS, COMPLICATIONS, DVT
The secondary outcomes were the overall incidence of DVT, rate of blood transfusion, the incidence of wound complications and superficial soft tissue infections, leg circumference and the visual analog scale (VAS) score. The circumference of the leg was measured before surgery and at postoperative day 7 by physiotherap...
PMC9996975
Statistical analyses and sample size
Statistical analyses were performed using the R software (The R Foundation for Statistical Computing). The comparisons between the two groups were performed using the Student’s
PMC9996975
Results
PMC9996975
Secondary outcomes
pain, DVT
DVT
The ultrasonographic examination at postoperative day 7 revealed DVT in the lower leg in two patients in the TXA group and two patients in the control group (Visual analog scale scores for pain at rest after surgeryVisual analog scale scores for pain during activity after surgery
PMC9996975
Discussion
blood loss, postoperative pain, arthroplasty, DVT
BLOOD LOSS, COMPLICATIONS, DVT
The most important finding of this study was that the intravenous administration of TXA reduced perioperative total blood loss in MOWDTO without increasing the incidence of DVT.This is the first randomized controlled study to examine the effectiveness of intravenous TXA administration in MOWDTO, which was developed as ...
PMC9996975
Conclusion
blood loss, bleeding, DVT
BLOOD LOSS, BLEEDING, DVT
Intravenous TXA administration in MOWDTO reduced the perioperative blood loss without increasing the risk of DVT. These study results suggest that intravenous administration of TXA might be an effective and safe measure for control of perioperative bleeding in this modified osteotomy procedure.
PMC9996975
Acknowledgements
Not applicable.
PMC9996975
Author contributions
TI developed the study design and drafted manuscript. RK, TI, SO and HN performed surgeries. SY and TT supervised the study. All authors read and approved the final manuscript.
PMC9996975
Funding
There was no external source of funding for this study.
PMC9996975
Availability of data and materials
The datasets used and/or analyzed during the current study are not publicly available due to their containing information that could compromise the privacy of research participants. However, the data are available from the corresponding author on reasonable request.
PMC9996975
Declarations
PMC9996975
Ethics approval and consent to participate
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Each author certifies that his institutional approved the human protocol...
PMC9996975
Competing interests
All authors report no competing interests with regard to this study.
PMC9996975
References
PMC9996975
Background
Peripheral neuropathy, amputation, diabetic, peripheral neuropathy, disability, diabetes
PERIPHERAL NEUROPATHY, PERIPHERAL NEUROPATHY, FOOT ULCERATION, DIABETES
Peripheral neuropathy is not only the most prevalent consequence of diabetes but also the main reason for foot ulceration, disability, and amputation. Therefore, the current study aims to determine the effectiveness of oral clonidine and gabapentin on peripheral neuropathy in diabetic patients.
PMC10577942
Methods
peripheral neuropathy, diabetic
TYPE 2 DIABETES, PERIPHERAL NEUROPATHY
This 12-week, randomized, and parallel-group trial was conducted to compare the efficacy of oral clonidine and gabapentin with gabapentin alone in diabetic patients in southwest Iran during the first half of 2021. Thirty patients with type 2 diabetes with peripheral neuropathy as assessed by a visual analog scale (VAS)...
PMC10577942
Results
neuropathic pain
The mean and standard deviation of the age of the participants in the clonidine + gabapentin group was equal to 50.20 ± 7.44, and in the gabapentin group was equal to 50.47 ± 7.57 (t = 0.10, P-value = 0.923). This research showed a significant difference between the clonidine + gabapentin group and with gabapentin grou...
PMC10577942
Conclusions
diabetic, neuropathic pain, diabetes
DIABETES
According to this research results, clonidine + gabapentin can reduce neuropathic pain and the severity of neuropathic pain in diabetic patients. Therefore, it is recommended that healthcare professionals with diabetes expertise prescribe these medications to reduce neuropathic pain and its severity.
PMC10577942
Trial registration
This study was registered in the Iranian Clinical Trials System with the ID (IRCT20211106052983N1) on 14/01/2022.
PMC10577942
Keywords
PMC10577942
Background
DM, metabolic disorder, Diabetic Peripheral Neuropathy, amputation, Diabetes Mellitus, Diabetic Neuropathy, hyperglycemia, DPN, diabetic, disability, diabetes
METABOLIC DISORDER, DIABETES MELLITUS, DIABETIC NEUROPATHY, COMPLICATION, HYPERGLYCEMIA, FOOT ULCERATION, DIABETES
Diabetes Mellitus (DM) is a metabolic disorder caused by low insulin production or function, resulting in chronic hyperglycemia [As a significant cause of foot ulceration, disability, and amputation, Diabetic Peripheral Neuropathy (DPN) is the most prevalent complication resulting from diabetes. More than 50% of diabet...
PMC10577942
Methods
allergic, neuropathic pain, neuropathy, hyperthyroidism, psychiatric, diabetic, hypotension, cardiovascular, kidney disease, peripheral neuropathy, diabetes
NEUROPATHY, HYPERTHYROIDISM, DRUG INTERACTION, HYPOTHYROIDISM, PERIPHERAL NEUROPATHY, DIABETES
The current research is a randomized clinical trial on two groups with a pre-intervention phase and three post-intervention assessments (after two, four, and eight weeks). The population consisted of all diabetic patients with peripheral neuropathy who sought medication in the diabetes clinic of Yasuj during the first ...
PMC10577942
Procedure
diabetic
STILL
In the present study, 49 diabetic patients were included using a purposeful sampling method. Thirty-four people entered the research process based on the entry criteria. Still, in operation, in each of the research groups, according to the exit criteria, two people left the research process. Finally, analyzed the infor...
PMC10577942
Measurements
PMC10577942
Michigan Diabetic Neuropathy Symptom score (DNS)
2-very, neuropathic pain, pain
DNS combines scores from a neurological examination and standard nerve conduction stimulation. A 128-hertz diapason generates vibration to calculate this variable, and pain is induced on the back of the examinee’s toe using a sharp tool. During this procedure, the examinee is asked yes/no questions and is expected to a...
PMC10577942
The pain visual analog scale (VAS)
pain
In the current investigation, the patients were asked to rate their pain on the visual analog scale (VAS). This measurement consists of a scoring system varying between 0 (no pain) to 10 (unbearable pain), being known as the pain ruler [
PMC10577942
Statistical analysis
neuropathic pain
In the current research, frequency, percentage, mean and standard deviation indicators were used to examine descriptive results. Also, to check the homogeneity of demographic and background variables, the Chi-square test, Fisher’s exact test, and independent t-test were used. In addition, an independent t-test was used...
PMC10577942
Results
neuropathic, neuropathic pain, pain
Table  The descriptive indexes result of homogeneity gender, and medications of the participants according to their groups* Chi-squared test; ** Fisher’s exact testAs can be seen in Table  The descriptive indexes and background information homogeneity of the patients suffering from neuropathic pain in pre-intervention ...
PMC10577942
Discussion
diabetic, peripheral neuropathy, diabetes
PERIPHERAL NEUROPATHY, HIGH BLOOD PRESSURE, DIABETES
The current research aimed to determine the effectiveness of oral clonidine and gabapentin on peripheral neuropathy in diabetic patients. The results indicated that combining clonidine and gabapentin significantly affected peripheral neuropathy more than a single gabapentin consumption. To the best of our knowledge, to...
PMC10577942