scholarly journals Helmet noninvasive ventilation for COVID-19 patients (Helmet-COVID): study protocol for a multicenter randomized controlled trial

2021 ◽  
Author(s):  
Yaseen Arabi ◽  
Haytham Tlayjeh ◽  
Sara Aldekhyl ◽  
Hasan Al-Dorzi ◽  
Sheryl Ann Abdukahil ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Usual Care ◽  
Noninvasive Ventilation ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Institutional Review Boards ◽  
Hypoxemic Respiratory Failure ◽  
Acute Hypoxemic Respiratory Failure ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial

Introduction Noninvasive ventilation delivered by helmet is has been used for respiratory support of patients with acute hypoxemic respiratory failure due to COVID-19 pneumonia. The aim of this study is to compare helmet noninvasive ventilation with usual care versus usual care alone to reduce the mortality. Methods and analysis This is a multicenter, pragmatic, parallel, randomized controlled trial that compares helmet noninvasive ventilation with usual care to usual care alone in 1:1 ratio. A total of 320 patients will be enrolled in this study. The primary outcome is 28-day all-cause mortality. The primary outcome will be compared between the two study groups in the intention-to-treat and per-protocol cohorts. An interim analysis will be conducted for both safety and effectiveness. Ethics and dissemination Approvals are obtained from the Institutional Review Boards (IRBs) of each participating institution. Our findings will be published in peer-review journals and presented at relevant conferences and meetings.

scholarly journals Effectiveness of at-home skin temperature monitoring in reducing the incidence of foot ulcer recurrence in people with diabetes: a multicenter randomized controlled trial (DIATEMP)

2021 ◽  
Vol 9 (1) ◽  
pp. e002392
Author(s):  
Sicco A Bus ◽  
Wouter B aan de Stegge ◽  
Jeff G van Baal ◽  
Tessa E Busch-Westbroek ◽  
Frans Nollet ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Usual Care ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Foot Ulcer ◽  
Ulcer Recurrence ◽  
Ambulatory Activity ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial ◽  
At Home

IntroductionThe skin of people with diabetic foot disease is thought to heat up from ambulatory activity before it breaks down into ulceration. This allows for early recognition of imminent ulcers. We assessed whether at-home monitoring of plantar foot skin temperature can help prevent ulcer recurrence in diabetes.Research design and methodsIn this parallel-group outcome-assessor-blinded multicenter randomized controlled trial (7 hospitals, 4 podiatry practices), we randomly assigned people with diabetes, neuropathy, foot ulcer history (<4 years, n=295), or Charcot’s neuro-arthropathy (n=9) to usual care (ie, podiatric treatment, education, and therapeutic footwear) or usual care plus measuring skin temperatures at 6–8 plantar sites per foot each day (enhanced therapy). If ∆T>2.2°C between corresponding sites on the left and right foot for two consecutive days, participants were instructed to reduce ambulatory activity until this hotspot disappeared and contact their podiatrist. Primary outcome was ulcer recurrence in 18 months on the plantar foot, interdigital, or medial/lateral/anterior forefoot surfaces; secondary outcome was ulcer recurrence at any foot site.ResultsOn the basis of intention-to-treat, 44 of 151 (29.1%) participants in enhanced therapy and 57 of 153 (37.3%) in usual care had ulcer recurrence at a primary outcome site (RR: 0.782 (95%CI 0.566 to 1.080), p=0.133). Of the 83 participants in enhanced therapy who measured a hotspot, the 24 subsequently reducing their ambulatory activity had significantly fewer ulcer recurrences (n=3) than those in usual care (RR: 0.336 (95% CI 0.114 to 0.986), p=0.017). Enhanced therapy was effective over usual care for ulcer recurrence at any foot site (RR: 0.760 (95% CI 0.579 to 0.997), p=0.046).ConclusionsAt-home foot temperature monitoring does not significantly reduce incidence of diabetic foot ulcer recurrence at or adjacent to measurement sites over usual care, unless participants reduce ambulatory activity when hotspots are found, or when aiming to prevent ulcers at any foot site.Trial registration numberNTR5403.

scholarly journals Effects of a Patient-Provider, Collaborative, Medication-Planning Tool: A Randomized, Controlled Trial

2016 ◽  
Vol 2016 ◽  
pp. 1-16 ◽  
Author(s):  
James F. Graumlich ◽  
Huaping Wang ◽  
Anna Madison ◽  
Michael S. Wolf ◽  
Darren Kaiser ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Glycemic Control ◽  
Usual Care ◽  
Controlled Trial ◽  
Medication Use ◽  
Type Ii Diabetes Mellitus ◽  
Planning Tool ◽  
Medication Knowledge ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial

Among patients with various levels of health literacy, the effects of collaborative, patient-provider, medication-planning tools on outcomes relevant to self-management are uncertain.Objective. Among adult patients with type II diabetes mellitus, we tested the effectiveness of a medication-planning tool (Medtable™) implemented via an electronic medical record to improve patients’ medication knowledge, adherence, and glycemic control compared to usual care.Design. A multicenter, randomized controlled trial in outpatient primary care clinics. 674 patients received either the Medtable tool or usual care and were followed up for up to 12 months.Results. Patients who received Medtable had greater knowledge about indications for medications in their regimens and were more satisfied with the information about their medications. Patients’ knowledge of drug indication improved with Medtable regardless of their literacy status. However, Medtable did not improve patients’ demonstrated medication use, regimen adherence, or glycemic control (HbA1c).Conclusion. The Medtable tool supported provider/patient collaboration related to medication use, as reflected in patient satisfaction with communication, but had limited impact on patient medication knowledge, adherence, and HbA1c outcomes. This trial is registered with ClinicalTrials.govNCT01296633.

scholarly journals Noninvasive ventilation vs. high-flow nasal cannula oxygen for preoxygenation before intubation in patients with obesity: a post hoc analysis of a randomized controlled trial

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Maeva Rodriguez ◽  
Stéphanie Ragot ◽  
Rémi Coudroy ◽  
Jean-Pierre Quenot ◽  
Philippe Vignon ◽  
...  
Keyword(s):  
Noninvasive Ventilation ◽  
Controlled Trial ◽  
High Flow ◽  
Severe Hypoxemia ◽  
Hypoxemic Respiratory Failure ◽  
Acute Hypoxemic Respiratory Failure ◽  
Randomized Controlled ◽  
Increased Risk ◽  
Post Hoc ◽  
Intubation Procedure

Abstract Background Critically ill patients with obesity may have an increased risk of difficult intubation and subsequent severe hypoxemia. We hypothesized that pre-oxygenation with noninvasive ventilation before intubation as compared with high-flow nasal cannula oxygen may decrease the risk of severe hypoxemia in patients with obesity. Methods Post hoc subgroup analysis of critically ill patients with obesity (body mass index ≥ 30 kg·m−2) from a multicenter randomized controlled trial comparing preoxygenation with noninvasive ventilation and high-flow nasal oxygen before intubation of patients with acute hypoxemic respiratory failure (PaO2/FiO2 < 300 mm Hg). The primary outcome was the occurrence of severe hypoxemia (pulse oximetry < 80%) during the intubation procedure. Results Among the 313 patients included in the original trial, 91 (29%) had obesity with a mean body mass index of 35 ± 5 kg·m−2. Patients with obesity were more likely to experience an episode of severe hypoxemia during intubation procedure than patients without obesity: 34% (31/91) vs. 22% (49/222); difference, 12%; 95% CI 1 to 23%; P = 0.03. Among patients with obesity, 40 received preoxygenation with noninvasive ventilation and 51 with high-flow nasal oxygen. Severe hypoxemia occurred in 15 patients (37%) with noninvasive ventilation and 16 patients (31%) with high-flow nasal oxygen (difference, 6%; 95% CI − 13 to 25%; P = 0.54). The lowest pulse oximetry values during intubation procedure were 87% [interquartile range, 77–93] with noninvasive ventilation and 86% [78–92] with high-flow nasal oxygen (P = 0.98). After multivariable analysis, factors independently associated with severe hypoxemia in patients with obesity were intubation difficulty scale > 5 points and respiratory primary failure as reason for admission. Conclusions Patients with obesity and acute hypoxemic respiratory failure had an increased risk of severe hypoxemia during intubation procedure as compared to patients without obesity. However, preoxygenation with noninvasive ventilation may not reduce this risk compared with high-flow nasal oxygen. Trial registration Clinical trial number: NCT02668458 (http://www.clinicaltrials.gov)

scholarly journals Cervical Pessary versus Expectant Management for the Prevention of Delivery Prior to 36 Weeks in Women with Placenta Previa: A Randomized Controlled Trial

2019 ◽  
Vol 09 (02) ◽  
pp. e160-e166
Author(s):  
Irene Stafford ◽  
Thomas Garite ◽  
Kimberly Maurel ◽  
C. Combs ◽  
Kent Heyborne ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Primary Outcome ◽  
Placenta Previa ◽  
Controlled Trial ◽  
Expectant Management ◽  
Randomized Controlled ◽  
Cervical Pessary ◽  
Multicenter Randomized Controlled Trial ◽  
To Receive ◽  
Type Of Delivery

Objective This multicenter randomized controlled trial compared cervical pessary (CP) versus expectant management (EM) in women with placenta previa between 22.0 and 32.0 in prolonging gestation until ≥ 36.0 weeks' gestation. Study Design This study took place from November 2016 to June 2018. Women were randomized to receive either the Bioteque CP or EM. The pessary was removed at ≥ 36.0 weeks unless indicated. The primary outcome was gestational age (GA) at delivery, with secondary outcomes including need for transfusion, number and duration of antepartum admissions, type of delivery, and neonatal outcomes. A total of 140 patients were needed to show a 3-week prolongation of pregnancy in the pessary group; however, the trial was stopped early due to budgetary issues. Results Of the 33 eligible women, 17 were enrolled. Although not statistically significant, the mean GA at delivery in the CP group was greater than women in the EM group (36.5 ± 1.23 vs. 36.0 ± 2.0; p = 0.1673). The number and duration of antepartum admissions was greater in the EM group (2.7 ± 0.58 vs. 16.0 ± 22.76 days; p = 0.1264) as well. Conclusion Although the study was underpowered to determine the primary outcome, safety and feasibility of CP in pregnancies complicated with previa were demonstrated.

scholarly journals Efficacy of acupuncture based on acupoint combination theory for irritable bowel syndrome: study protocol for a multicenter randomized controlled trial

2021 ◽  
Author(s):  
Jing-wen Sun ◽  
Zhi-gang Li ◽  
Ming-liang Sun ◽  
Da Li ◽  
Jun Zhao ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Irritable Bowel Syndrome ◽  
Social Adjustment ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Self Rating ◽  
Multicenter Randomized Controlled Trial ◽  
Secondary Outcomes ◽  
Irritable Bowel

Abstract Background: Irritable bowel syndrome (IBS) is a chronic gastrointestinal disorder characterized by abdominal pain, diarrhea or constipation, and changes in defecation patterns. No organic disease has been found to explain these symptoms by routine clinical examination. This study aims to investigate the efficacy and safety of acupuncture therapy for IBS patients based on conventional treatments. We also want to explore the optimal acupoint combination recommended for IBS and clarify the clinical advantage of "multi-acupoint co-effect and synergistic effect".Methods and analysis: A total of 204 eligible patients who meet the Rome IV criteria for IBS will be randomly allocated to receive different acupuncture. Each patient will receive 12 acupuncture treatments over four weeks and will be followed up for four weeks. The primary outcome is the IBS-symptom severity score (IBS-SSS). The secondary outcomes include the Bristol stool form scale(BSFS), the work and social adjustment score (WSAS), the IBS-quality of life (IBS-QOL), self-rating anxiety scale (SAS), and the self-rating depression scale (SDS). Both the primary outcome and the secondary outcomes measures are collected at baseline, 2 weeks, and 4 weeks of the intervention, 6 weeks, and 8 weeks after the intervention.Ethics and dissemination: The entire project has been approved by the ethics committee of Beijing University of Chinese Medicine ( 2020BZYLL0903 ) .Discussion: This is a multicenter randomized controlled trial for IBS in China. This may shed light on the efficacy of acupuncture as an alternative to IBS. The results of the trial will be disseminated in peer-reviewed publications. Trial registration: Chinese Clinical Trials Register, ID: ChiCTR2000041215.First registered on 12 December 2020. http://www.chictr.org.cn/.

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