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Declarations | PMC9862555 | |||
Ethics approval and consent to participate | The study described herein is part of a minimal risk protocol registered with ClinicalTrials.gov (NCT03457415), reviewed and approved by the Sterling Institutional Review Board (Atlanta, GA), and conducted according to ethical principles of the Declaration of Helsinki (v 1996) and Good Clinical Practice guidelines. Par... | PMC9862555 | ||
Consent for publication | Not applicable. | PMC9862555 | ||
Competing interests | bioAffinity, SAH | MEL received payment from bioAffinity Technologies for services provided. XTR, JR, LHB, PRA, JS, MG, S-CL and VIR are current or past employees of bioAffinity. The respective affiliated hospitals and medical facilities of LRD, SAH, DGH, KL and LP received payment from bioAffinity for patient sample collection LRD, SAH,... | PMC9862555 | |
References | PMC9862555 | |||
Background | STILL | Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) has received extensive attention for its utility in tubeless anesthesia. Still, the effects of its carbon dioxide accumulation on emergence from anesthesia have not been reported. This randomized controlled trial aimed at exploring the impact of THR... | PMC10262498 | |
Methods | After research ethics board approval, 40 eligible patients receiving elective microlaryngeal vocal cord polypectomy were randomly allocated 1:1 to two groups, THRIVE + LM group: intraoperative apneic oxygenation using THRIVE followed by mechanical ventilation through a laryngeal mask in the post-anesthesia care unit (P... | PMC10262498 | ||
Results | Duration of PACU stay (22.4 ± 6.4 vs. 28.9 ± 8.8 min, | PMC10262498 | ||
Conclusions | cough | The THRIVE + LM strategy could accelerate emergence from anesthesia and reduce the incidence of cough without compromising oxygenation. However, these benefits did not convert to the QoR-40 and VHI-10 scores improvement | PMC10262498 | |
Trial registration | ChiCTR2000038652. | PMC10262498 | ||
Keywords | PMC10262498 | |||
Introduction | cough, cardiogenic | SECONDARY | The most crucial consideration for anesthesia management in upper airway surgery is to maintain the patient's airway for optimal surgical exposure as well as to keep adequate ventilation and depth of anesthesia. Tubeless anesthesia provides an unobstructed surgical field, thus is more preferable in shared airway surger... | PMC10262498 |
Methods | EYE | This study was approved by the Ethics Committee of Eye & ENT Hospital of Fudan University (2018033–1) and registered at | PMC10262498 | |
Patient inclusion and exclusion criteria | obesity, bronchiectasis, upper respiratory tract infection, fracture, allergy, pulmonary diseases, cardiovascular or cerebrovascular diseases | OBESITY, UPPER RESPIRATORY TRACT INFECTIONS, NEUROMUSCULAR DISORDERS, BRONCHIECTASIS, AIRWAY OBSTRUCTION, ALLERGY, PULMONARY DISEASES, GASTROESOPHAGEAL REFLUX DISEASE | All patients were aged 18–60 years, had an ASA physical status 1–2, and were scheduled for elective microlaryngeal vocal cord polypectomy with anticipated surgery time less than 20 min. Exclusion criteria are: severe upper airway obstruction, known difficult mask ventilation or difficult intubation, skull base fracture... | PMC10262498 |
Randomization | An independent research coordinator used SPSS (Version 23.0) to make randomized number sequence and prepared sealed and opaque envelopes according to the number sequence. Anesthesiologists assigned eligible patients using these envelopes before anesthesia induction. Patients were randomly assigned to either intraoperat... | PMC10262498 | ||
Anesthesia management | bradycardia, postoperative nausea and vomiting, hypotension | NEUROMUSCULAR BLOCKADE | All patients received routine preoperative preparation with no premedication. Standard intraoperative monitoring, including five lead electrocardiography, pulse oximetry, non-invasive blood pressure, bispectral index, and transcutaneous carbon dioxide (Sentec®, SenTec AG, Terwill, Switzerland), was applied to all patie... | PMC10262498 |
Outcomes | SECONDARY | The primary outcome was the duration of PACU stay. The time was counted from the end of surgery until patients met the discharge criteria of PACU. The Modified Aldrete Score was used as PACU discharge criteria. Patient’s activity level, respiration, circulation, consciousness and oxygen saturation were evaluated. The p... | PMC10262498 | |
Sample size and statistical analysis | SD | Based on our previous clinical data, the average duration of PACU stay in patients undergoing microlaryngeal vocal cord polypectomy was about 30 min. The sample size of this trial was calculated based on the assumption that the difference in duration of PACU stay between the THRIVE + LM group and MV + ETT group was mor... | PMC10262498 | |
Discussion | hoarseness, impaired pulmonary function, throat, cough, postoperative adverse events such as, hypercapnia-induced, hypercapnia, non-obese, shortness of breath | ADVERSE EVENTS, WOUND BLEEDING, CORTEX | THRIVE could maintain oxygenation without blocking the view of surgical field, especially when operating lesions at the middle and lower part of vocal cords. However, the intraoperative carbon dioxide accumulation may affect the quality of emergence from general anesthesia in patients using THRIVE. LM is less irritatin... | PMC10262498 |
Conclusions | cough | Compared with mechanical ventilation through an endotracheal tube, the THRIVE + LM ventilation strategy in patients undergoing microlaryngeal vocal cord polypectomy could accelerate the spontaneous respiration recovery, airway tool removal, and PACU discharge without compromising oxygenation. Furthermore, the incidence... | PMC10262498 | |
Acknowledgements | EYE | We would like to thank all the stuff of Eye & ENT Hospital surgery center for their kind support. | PMC10262498 | |
Funding | This study was supported in part by grants-in-aid for scientific research from the Natural Science Foundation of Shanghai (21ZR1411300) and Shenkang Clinical Study Foundation of Shanghai (SHDC2020CR4061) to Dr. Han; the National Natural Science Foundation of China (82171264), Shanghai Municipal Health and Family Planni... | PMC10262498 | ||
Availability of data and materials | The datasets generated and analyzed during the current study are not publicly available due to institutional restrictions but are available from the corresponding author on reasonable request. | PMC10262498 | ||
Declarations | PMC10262498 | |||
Ethics approval and consent to participate | EYE | This study was approved by the Ethics Committee of Eye & ENT Hospital of Fudan University (2018033–1) and registered at | PMC10262498 | |
Consent for publication | Not Applicable. | PMC10262498 | ||
Competing interests | The authors declare no competing interests. | PMC10262498 | ||
References | PMC10262498 | |||
Background | The optimal treatment strategy for resectable | PMC10440878 | ||
Methods | The NEXUS trial is a multicenter phase II clinical study evaluating the efficacy and safety of the perioperative use of encorafenib, binimetinib, and cetuximab in patients with previously untreated surgically resectable | PMC10440878 | ||
Discussion | The use of the triplet regimen in the perioperative period is expected to be safe and effective in patients with resectable | PMC10440878 | ||
Trial registration | jRCT2031220025, April. 16, 2022. | PMC10440878 | ||
Keywords | PMC10440878 | |||
Backgrounds | BRAF is a serine/threonine kinase that belongs to the Recently, the BEACON CRC trial, which enrolled patients with previously treated unresectable The BEACON CRC trial was followed by the ANCHOR CRC trial wherein the effectiveness of the triplet regimen was evaluated in patients with previously untreated unresectable T... | PMC10440878 | ||
Methods/Design | PMC10440878 | |||
Patient screening | Patients with resectable CRM at institutions participating in the NEXUS trial were screened for | PMC10440878 | ||
Study design and treatment | The NEXUS trial is a multicenter phase II clinical study that will evaluate the efficacy and safety of the perioperative use of encorafenib, binimetinib, and cetuximab (the BEACON triplet regimen) in patients with previously untreated but surgically resectable Eligibility criteria of the NEXUS study | PMC10440878 | ||
Endpoints | toxicity, Tumors | ADVERSE EVENTS, DISEASE, TUMORS, PROGRESSION, SECONDARY, COMPLICATIONS | The primary endpoint is the 1-year PFS rate, and the secondary endpoints are the PFS, DFS, OS, 1-year PFS rate by central image review, ORR, pathological complete response (CR) rate of distant metastatic lesions and the primary lesion as assessed by pathologists at each institution, protocol treatment completion rate, ... | PMC10440878 |
Sample size and statistical analysis | As the 1-year DFS in patients with | PMC10440878 | ||
Translational analysis | tumor | TUMOR | Multi-omics analysis of both tumor tissues and blood specimens at enrollment, resection, and relapse will be performed to investigate the prognostic factors (MONSTAR-2 study, UMIN000043899) [ | PMC10440878 |
Planned regulatory approval | COMPLICATIONS | Since the NEXUS trial is a single-arm study, the efficacy and safety data will be compared with those of the RWD in the registry, wherein treatments other than this protocol treatment were administered to the same subjects. PFS, DFS, OS, and incidence of surgery-related complications in the NEXUS trial will be compared... | PMC10440878 | |
Discussion | Since the discovery of the notorious While survival outcomes of patients with surgically resected Although two decades have passed since the detrimental impact of | PMC10440878 | ||
Acknowledgements | We are grateful to all participating patients, their families, and all investigators involved in the NEXUS trial. | PMC10440878 | ||
Authors’ contributions | SK, HB, ST, and TY conceived study concepts. SK, HB, AT, TT, ES, MS, HH, KY, KK, NM, TK, YK, MY, EO, RK, MW, ST, TY designed the study protocol. MW is engaged in statistical analysis. All the authors have read and approved the final manuscript. | PMC10440878 | ||
Funding | The NEXUS trial is funded by the Advanced Research and Development Programs for Medical Innovation of Japan Agency for Medical Research and Development (21lk0201148h0001). Encorafenib and binimetinib were provided by ONO PHARMACEUTICAL CO., LTD., and cetuximab was provided by Merck Biopharma Co., Ltd., Tokyo, Japan, an... | PMC10440878 | ||
Availability of data and materials | Data sharing is not applicable to this paper. | PMC10440878 | ||
Declarations | PMC10440878 | |||
Ethics approval and consent to participate | Cancer | CANCER | The current study has been approved by the Institutional Review Board of National Cancer Center Hospital East (EPOC2101), and permission for conducting the study has been obtained from the IRB of all participating facilities. All procedures will be performed in accordance with the protocol, Declaration of Helsinki, gov... | PMC10440878 |
Consent for publication | Not applicable. | PMC10440878 | ||
Competing interests | Johnson & Johnson, and Asahi Surgical Robotics | SK reports honoraria from Ono, Johnson & Johnson, and Asahi Surgical Robotics.HB reports research funding from Takeda, Daiichi Sankyo, and Sysmex, and honoraria from Takeda, Chugai, Taiho, and Eli Lilly.ES reports honoraria from Takeda, Merck, Eli Lily, and Chugai.MS reports honoraria from Eli Lilly, Takeda, Taiho, Ono... | PMC10440878 | |
References | PMC10440878 | |||
Background | Respiratory distress syndrome | RESPIRATORY DISTRESS SYNDROME | Respiratory distress syndrome is the main cause of mortality and morbidity in preterm infants. “Less invasive surfactant administration” (LISA), which describes intratracheal surfactant administration to spontaneously breathing infants via a small diameter tube, is recommended as the first-line treatment in preterm inf... | PMC10523706 |
Methods | Preterm infants with a gestational age between 25 weeks + 0 days and 28 weeks + 6 days who are breathing spontaneously on continuous positive airway pressure with supplemental oxygen at or below 30% in the first hour of life will be randomised to a prophylactic LISA treatment with 100–200 mg surfactant intratracheally ... | PMC10523706 | ||
Discussion | Robust data concerning the possible long-term benefits of prophylactic LISA treatment are lacking. The current observational data from the German Neonatal Network indicate that approximately 50% of preterm infants with supplemental oxygen at or below 30% within the first hour of life are treated with LISA. The pro.LISA... | PMC10523706 | ||
Trial registration | German Clinical Trials Register DRKS00028086. Prospectively registered on 8 February 2022. | PMC10523706 | ||
Keywords | Open Access funding enabled and organized by Projekt DEAL. | PMC10523706 | ||
Administrative information | Tanja K. | Note: The numbers in curly brackets in this protocol refer to the SPIRIT checklist item numbers. The order of the items has been modified to group similar items (see Wolfgang Göpel, Egbert Herting and Guido Stichtenoth: Department of Pediatrics, University Hospital Schleswig–Holstein, University of Lübeck, Germany.Barb... | PMC10523706 | |
Introduction | PMC10523706 | |||
Background and rationale {6a} | Less invasive surfactant administration (LISA) describes intratracheal surfactant administration via a small diameter tube to spontaneously breathing infants [Observational data from the GNN indicate that in infants with gestational age 25–28 weeks and FiOProphylactic surfactant therapy via an endotracheal tube is not ... | PMC10523706 | ||
Objectives {7} | The primary hypothesis of the pro.LISA study is that there is a difference in forced expiratory volume within 1 s (FEV | PMC10523706 | ||
Trial design {8} | The pro.LISA study is a prospective, randomised, controlled, parallel-group, single-blinded, multicentre, national trial. Patients will be assigned in a 50:50% ratio to the intervention and control groups. The purpose of the trial is to show the superiority of the intervention with regard to the primary endpoint. | PMC10523706 | ||
Methods: participants, interventions, and outcomes | PMC10523706 | |||
Study setting {9} | Neonatal intensive care units in Germany are enrolled as participating sites. A list of participating centres is given in the “Acknowledgements” section. | PMC10523706 | ||
Eligibility criteria {10} | Lethal malformations | The following are the inclusion criteria:Preterm infants with gestational age between 25 weeks and 0 days and 28 weeks and 6 daysAge < 60 minSpontaneous breathingPulse oximetric measured oxygen saturation ≥ 90% at FiOWritten informed consent of at least one legal guardianThe following is the exclusion criteria:Lethal m... | PMC10523706 | |
Who will take informed consent? {26a} | PRETERM DELIVERY | Pregnant women who are admitted to a centre participating in the pro.LISA trial with threatening preterm delivery before 29 weeks of gestation will be approached. Both parents/legal guardians will be asked for consent before enrolment. In case of an emergency situation (e.g. emergency C-section), the consent of only on... | PMC10523706 | |
Additional consent provisions for collection and use of participant data and biological specimens {26b} | Parents/legal guardians give consent for the collection and analysis of data to study the safety and efficacy of prophylactic LISA treatment. This includes the use of data for regulatory purposes and ancillary analyses (e.g. meta-analyses). All sites of the pro.LISA trial are part of the German Neonatal Network (GNN). ... | PMC10523706 | ||
Interventions | PMC10523706 | |||
Explanation for the choice of comparators {6b} | For preterm infants breathing spontaneously on CPAP, surfactant therapy if FiO | PMC10523706 | ||
Intervention description {11a} | PMC10523706 | |||
Intervention group | A small diameter tube (according to local standards) is placed via laryngoscopy in the trachea of the infant. Surfactant (100–200 mg/kg body weight) is administered while the baby is breathing spontaneously. Thereafter, the small diameter tube is removed and CPAP with positive end-expiratory pressure level of at least ... | PMC10523706 | ||
Control group | In the control group, CPAP with a positive end-expiratory pressure level of at least 6 cm H | PMC10523706 | ||
Criteria for discontinuing or modifying allocated interventions {11b} | The intervention (prophylactic surfactant) will be applied immediately after enrolment. No criteria for modifications were defined. | PMC10523706 | ||
Strategies to improve adherence to interventions {11c} | Interventions are documented in the intervention and control groups immediately after randomisation. Due to the short timeframe for the intervention, and the intensive care setting, no strategies to improve adherence were defined. | PMC10523706 | ||
Relevant concomitant care permitted or prohibited during the trial {11d} | The only prohibited therapy is prophylactic surfactant in the control group. | PMC10523706 | ||
Provisions for post-trial care {30} | Patients who are enrolled in the study are covered by patient insurance (Newline Group). | PMC10523706 | ||
Outcomes {12} | bleeding, IVH, dysplasia, ductus arteriosus, DeathIntraventricular haemorrhage, BPD, intestinal perforation | BLEEDING, NECROTISING ENTEROCOLITIS, PERIVENTRICULAR LEUKOMALACIA, DYSPLASIA, OBSTRUCTIVE BRONCHITIS, CEREBRAL PALSY, INTESTINAL PERFORATION, RETINOPATHY OF PREMATURITY | The primary endpoint of this study is FEVFVC FEVLength in metres of running track in 3-min running test according to [Cerebral palsy defined as Gross Motor Function Classification System value > 1Score in Movement Assessment Battery for ChildrenIntelligence assessed by Wechsler Preschool and Primary Scale of Intelligen... | PMC10523706 |
Participant timeline {13} | PMC10523706 | |||
Sample size {14} | The clinical aim is to detect a mean difference in FEV | PMC10523706 | ||
Recruitment {15} | At the time of this report, patients are recruited in 20 neonatal intensive care units in Germany. Names of site investigators and affiliations are given in the “Acknowledgements” section. Enrolment of one or two patients per month per centre will ensure enrolment of the target sample size within 30 months. However, th... | PMC10523706 | ||
Assignment of interventions: allocation | PMC10523706 | |||
Sequence generation {16a} | A stratified permuted block randomisation is used with stratification by gestational age (25 and 26 weeks vs. 27 and 28 weeks), multiple birth status, and participating study centres. The randomisation lists are prepared by the Institute of Medical Biometry and Statistics. | PMC10523706 | ||
Concealment mechanisms {16b} | Sequentially numbered opaque, sealed envelopes are provided to participating centres for the allocation of patients. | PMC10523706 | ||
Implementation {16c} | Generation of allocation sequence and provision of randomisation envelopes is done by persons and institutions who are not involved in patient enrolment. | PMC10523706 | ||
Assignment of interventions: blinding | PMC10523706 | |||
Who will be blinded {17a} | Blinding of physicians and nurses for the intervention is not possible in this study. Parents and outcome assessors of the primary outcome at age 5 years will be blinded to the procedure. | PMC10523706 | ||
Procedure for unblinding if needed {17b} | Since physicians are not blinded, this will be not relevant. | PMC10523706 | ||
Data collection and management | PMC10523706 | |||
Plans for assessment and collection of outcomes {18a} | Data of the pro.LISA trial are collected in an online database in the Castor EDC system [ | PMC10523706 | ||
Plans to promote participant retention and complete follow-up {18b} | We expect that follow-up until discharge from the hospital will be very close to 100%. For long-term follow-up, we are planning to contact parents every 6–12 months via phone or mail to minimise loss to follow-up. | PMC10523706 | ||
Data management {19} | All study data are collected at a central online database. Details for data security and storage are given on the website [ | PMC10523706 | ||
Confidentiality {27} | Since we need the contact information of parents for follow-up, these data are entered in the pro.LISA online database. Access to the pro.LISA online database is limited to investigators (who have only access to patient data of their own site) and qualified personnel from the study centre (University of Lübeck). | PMC10523706 | ||
Plans for collection, laboratory evaluation, and storage of biological specimens for genetic or molecular analysis in this trial/future use {33} | In the pro.LISA trial, no biological specimens are collected. We encourage parents to participate in the GNN cohort study in addition to the pro.LISA trial. In the GNN cohort study, deoxyribonucleic acid samples of participating infants are collected. | PMC10523706 | ||
Statistical methods | PMC10523706 | |||
Statistical methods for primary and secondary outcomes {20a} | All details of statistical analyses will be specified in the statistical analysis plan, which will be finalised before the inclusion of the last patient. The primary and other efficacy endpoints will be analysed in the full analysis population. Patients who died before the 5-year follow-up and patients who were not abl... | PMC10523706 | ||
Interim analyses {21b} | No interim analyses are planned. | PMC10523706 | ||
Methods for additional analyses (e.g. subgroup analyses) {20b} | A sensitivity analysis will be done for the primary endpoint adjusted for smoking during pregnancy and any breastfeeding during the stay in the hospital. No further subgroup analyses are planned. | PMC10523706 | ||
Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c} | SECONDARY | The primary and secondary endpoints can only be examined if the patients are able to conduct the tests. Patients who are not able to conduct the tests and patients who died before the assessment will be excluded from the full analysis set.Other scenarios for not conducting a follow-up are the following: unattainability... | PMC10523706 | |
Plans to give access to the full protocol, participant-level data, and statistical code {31c} | SECONDARY | After analysis and publication of the primary and secondary outcome data, full access to de-identified patient-level outcome data, the full protocol of the trial, and the statistical code will be available upon reasonable request. | PMC10523706 | |
Oversight and monitoring | PMC10523706 | |||
Composition of the coordinating centre and trial steering committee {5d} | The trial management group includes the principal investigator, clinical and administrative research associates, research nurses, data managers, and statisticians. The trial management group has weekly meetings. Reports concerning site-specific enrolment numbers are provided to participating sites and the data and safe... | PMC10523706 |
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