The Variable Ventilation Trial (Part A) (VV (A))
2026년 8월 25일 업데이트: Rebecca Baron, Brigham and Women's Hospital
A Bayesian, Operationally Seamless Adaptive Phase 2A/2B, Open-label, Multi-center, Randomized, Two-part Trial to Evaluate the Safety, Efficacy, and Optimal Tidal Volume Distribution of Variable Ventilation (VV) in Participants Undergoing Mechanical Ventilatory Support for Acute Respiratory Distress Syndrome
The goal of this clinical trial is to learn if a breathing machine (ventilator) method called "variable ventilation" can help protect the lungs of adult patients with acute respiratory distress syndrome (ARDS) who need help breathing through a ventilator. In variable ventilation, the size of each breath given by the machine changes slightly from breath to breath, instead of staying the same size in every breath. The study has two parts, A (safety and feasibility) and B (efficacy). This entry will cover the part A (safety study).
The main questions part A aims to answer are:
- Is variable ventilation safe to use in adults with ARDS?
- Is it feasible to deliver this method of ventilation to patients?
Researchers will compare variable ventilation to the standard breathing machine method used today to see if variable ventilation is safe and feasible.
Participants will be placed on an FDA approved ventilator that can deliver conventional mechanical ventilation and variable ventilation. Participants will:
- Have a period of stabilization on conventional ventilation, followed by 24 hours of variable ventilation, followed by 24 hours of conventional ventilation.
- Be checked regularly for breathing, oxygen levels, lung function, and plasma biomarkers.
연구 개요
연구 유형
중재적
등록 (추정된)
20
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Rebecca Baron, MD
- 전화번호: 617-525-6642
- 이메일: rbaron@bwh.harvard.edu
연구 장소
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Alabama
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Birmingham, Alabama, 미국, 35294
- University of Alabama at Birmingham
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연락하다:
- Peter Morris, MD
- 이메일: pmorris@uabmc.edu
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Massachusetts
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Springfield, Massachusetts, 미국, 01199
- Baystate Health
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연락하다:
- Mark Tidswell, MD
- 이메일: mark.tidswell@baystatehealth.org
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New York
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The Bronx, New York, 미국, 10461
- Montefiore Einstein
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연락하다:
- Luke Andrea
- 전화번호: 314-705-0925
- 이메일: landrea@montefiore.org
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연락하다:
- Daniel Ceusters
- 이메일: dceuster@montefiore.org
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Oregon
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Portland, Oregon, 미국, 97239-3098
- Oregon Health & Science University
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Utah
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Murray, Utah, 미국, 84107
- Intermountain Health Intermountain Medical Center
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연락하다:
- Jessica Reimer
- 이메일: Jessica.Reimer@imail.org
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연락하다:
- Emma Murphy
- 이메일: Emma.Murphy@imail.org
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Patients ≥21 years old admitted to the Surgical, Trauma, Burn, Coronary or Medical ICUs with ARDS according to the Berlin criteria [50] and requiring mechanical ventilation will be eligible for inclusion.
- Not more than 96 hours of mechanical ventilation before randomization
- Anticipated need for at least 48 more hours of controlled mechanical ventilation
Intubated and mechanically ventilated for ARDS according to the Berlin criteria
- Hypoxemia of acute onset, within the past 7 days
- Mild or moderate hypoxemia, PaO2/FiO2 ratio 100 - 300 mm Hg
- Presence of a risk factor for ARDS
- Respiratory failure not fully explained by cardiac failure or fluid overload
- Bilateral opacities not explained by effusions, lobar collapse, or nodules
Exclusion Criteria:
Demographic
- Age less than 21 years
- Pregnant or breastfeeding
- Prisoner
- Concurrent participation in another investigational drug study
- Patient, surrogate, or physician not committed to full support (exception: a patient will not be excluded if they would receive all supportive care except for attempts at resuscitation from cardiac arrest)
- No consent or inability to obtain consent or appropriate legal representative not available
- Physician refusal to allow enrollment in the trial
- Moribund patient not expected to survive 24 hours
- Treating team unwilling to use ARDS network low tidal volume strategy or variable ventilation mode
- Use, or planned use of ECMO
- Stroke (ischemic or hemorrhagic) or traumatic brain injury (TBI) within the prior 3 months
- Burns > 40% total body surface area (TBSA)
- Severe airway inhalational injury
- Diffuse alveolar hemorrhage
Any of the following hallmarks of Severe COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) grade 3 or 4
- FEV1 < 50% predicted
- Resting arterial blood gas values PaO2<55, SaO2<88%, or PaCO2>55
- Home invasive or non-invasive ventilation other than for sleep apnea
- Cor Pulmonale
- Candidate for, or has received, lung volume reduction surgery, bronchoscopic intervention to reduce end-expiratory lung volume, or lung transplantation
Any of the following cardiac problems:
- Acute myocardial infarction (MI) or acute coronary syndrome within the last 90 days
- Coronary artery bypass graft (CABG) surgery within 30 days
- Angina pectoris, or use of nitrates, with activities of daily living
- Cardiopulmonary disease classified as NYHA class IV
Physiological Exclusions
- Evidence of current barotrauma (e.g., pneumothorax, pneumomediastinum, or subcutaneous emphysema)
- Hemodynamic instability defined by inability to maintain a mean arterial pressure > 60 mm Hg.
- Other respiratory instability PEEP ≥18 cmH2O, suctioning more than hourly, Pplateau > 35 cm H2O, severe respiratory acidosis pH<7.25.
- Increased ICP > 20 cmH2O or mechanism of injury leading to concern for increased ICP
- Active bleeding with hemodynamic instability.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 순차적 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Variable Ventilation
Strategy of mechanical ventilation based on varying tidal volume breath to breath to provide therapeutic benefits in patients with ARDS.
The variable ventilation (VV) strategy will be implemented on a commercially available ventilator.
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Strategy of mechanical ventilation based on varying tidal volume breath to breath to provide therapeutic benefits in patients with ARDS.
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위약 비교기: Conventional Ventilation
Standard strategy of mechanical ventilation based on constant size low tidal volume implemented on a commercially available ventilator.
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Strategy of mechanical ventilation based on delivery of a constant size low tidal volume.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Safety assessed by the incidence of pre-specified AEs over the first 24 hours
기간: Maximum of 24 hours of VV
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Barotrauma
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Maximum of 24 hours of VV
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Safety assessed by the incidence of pre-specified AEs over the first 24 hours
기간: Maximum of 24 hours of VV
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Worsening Hypoxemia
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Maximum of 24 hours of VV
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Safety assessed by the incidence of pre-specified AEs over the first 24 hours
기간: Maximum of 24 hours of VV
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Worsening ventilation
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Maximum of 24 hours of VV
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Safety assessed by the incidence of pre-specified AEs over the first 24 hours
기간: Maximum of 24 hours of VV
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New onset arrhythmia requiring cardioversion
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Maximum of 24 hours of VV
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Safety assessed by the incidence of pre-specified AEs over the first 24 hours
기간: Maximum of 24 hours of VV
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Hemodynamic instability
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Maximum of 24 hours of VV
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Safety assessed by the incidence of pre-specified AEs over the first 24 hours
기간: Maximum of 24 hours of VV
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ST-segment elevation myocardial infarction
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Maximum of 24 hours of VV
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Safety assessed by the incidence of pre-specified AEs over the first 24 hours
기간: Maximum of 24 hours of VV
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Self-extubation
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Maximum of 24 hours of VV
|
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Safety assessed by the incidence of pre-specified AEs over the first 24 hours
기간: Maximum of 24 hours of VV
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Stroke
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Maximum of 24 hours of VV
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Safety assessed by the incidence of pre-specified AEs over the first 24 hours
기간: Maximum of 24 hours of VV
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Death
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Maximum of 24 hours of VV
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Lung mechanics
기간: Every 12 hours to maximum of 24 hours of VV
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Lung compliance, airways resistance, peak and plateau pressures
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Every 12 hours to maximum of 24 hours of VV
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Gas exchange
기간: Every 12 hours to maximum of 24 hours of VV
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SpO2, PaO2/FiO2 ratio, oxygenation index, dead space, and lung injury score.
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Every 12 hours to maximum of 24 hours of VV
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Feasibility of VV implementation.
기간: Every 12 hours during 24 hours of VV
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Qualitative feedback from Research and Clinical staff of the device and implementation in the ICU setting.
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Every 12 hours during 24 hours of VV
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
수사관
- 수석 연구원: Rebecca Baron, MD, Brigham and Women's Hospital
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Dellaca RL, Aliverti A, Lo Mauro A, Lutchen KR, Pedotti A, Suki B. Correlated variability in the breathing pattern and end-expiratory lung volumes in conscious humans. PLoS One. 2015 Mar 24;10(3):e0116317. doi: 10.1371/journal.pone.0116317. eCollection 2015.
- Arold SP, Suki B, Alencar AM, Lutchen KR, Ingenito EP. Variable ventilation induces endogenous surfactant release in normal guinea pigs. Am J Physiol Lung Cell Mol Physiol. 2003 Aug;285(2):L370-5. doi: 10.1152/ajplung.00036.2003.
- Arold SP, Mora R, Lutchen KR, Ingenito EP, Suki B. Variable tidal volume ventilation improves lung mechanics and gas exchange in a rodent model of acute lung injury. Am J Respir Crit Care Med. 2002 Feb 1;165(3):366-71. doi: 10.1164/ajrccm.165.3.2010155.
- Bellardine CL, Hoffman AM, Tsai L, Ingenito EP, Arold SP, Lutchen KR, Suki B. Comparison of variable and conventional ventilation in a sheep saline lavage lung injury model. Crit Care Med. 2006 Feb;34(2):439-45. doi: 10.1097/01.ccm.0000196208.01682.87.
- Berry CA, Suki B, Polglase GR, Pillow JJ. Variable ventilation enhances ventilation without exacerbating injury in preterm lambs with respiratory distress syndrome. Pediatr Res. 2012 Oct;72(4):384-92. doi: 10.1038/pr.2012.97. Epub 2012 Jul 17.
- Bartolak-Suki E, Noble PB, Bou Jawde S, Pillow JJ, Suki B. Optimization of Variable Ventilation for Physiology, Immune Response and Surfactant Enhancement in Preterm Lambs. Front Physiol. 2017 Jun 23;8:425. doi: 10.3389/fphys.2017.00425. eCollection 2017.
- Arold SP, Bartolak-Suki E, Suki B. Variable stretch pattern enhances surfactant secretion in alveolar type II cells in culture. Am J Physiol Lung Cell Mol Physiol. 2009 Apr;296(4):L574-81. doi: 10.1152/ajplung.90454.2008. Epub 2009 Jan 9.
- Suki B, Alencar AM, Sujeer MK, Lutchen KR, Collins JJ, Andrade JS Jr, Ingenito EP, Zapperi S, Stanley HE. Life-support system benefits from noise. Nature. 1998 May 14;393(6681):127-8. doi: 10.1038/30130. No abstract available.
- Pillow JJ, Musk GC, McLean CM, Polglase GR, Dalton RG, Jobe AH, Suki B. Variable ventilation improves ventilation and lung compliance in preterm lambs. Intensive Care Med. 2011 Aug;37(8):1352-9. doi: 10.1007/s00134-011-2237-x. Epub 2011 May 13.
- Suki B, Parameswaran H, Imsirovic J, Bartolak-Suki E. Regulatory Roles of Fluctuation-Driven Mechanotransduction in Cell Function. Physiology (Bethesda). 2016 Sep;31(5):346-58. doi: 10.1152/physiol.00051.2015.
- Bartolak-Suki E, Imsirovic J, Parameswaran H, Wellman TJ, Martinez N, Allen PG, Frey U, Suki B. Fluctuation-driven mechanotransduction regulates mitochondrial-network structure and function. Nat Mater. 2015 Oct;14(10):1049-57. doi: 10.1038/nmat4358. Epub 2015 Jul 27.
- Pillow JJ, Bartolak-Suki E, Noble PB, Berry CA, Suki B. Surfactant Protein Production during Maturation Is Enhanced by Natural Variability in Breathing. Am J Respir Cell Mol Biol. 2023 Jul;69(1):115-118. doi: 10.1165/rcmb.2022-0411LE. No abstract available.
- Thammanomai A, Hueser LE, Majumdar A, Bartolak-Suki E, Suki B. Design of a new variable-ventilation method optimized for lung recruitment in mice. J Appl Physiol (1985). 2008 May;104(5):1329-40. doi: 10.1152/japplphysiol.01002.2007. Epub 2008 Mar 13.
- Thammanomai A, Hamakawa H, Bartolak-Suki E, Suki B. Combined effects of ventilation mode and positive end-expiratory pressure on mechanics, gas exchange and the epithelium in mice with acute lung injury. PLoS One. 2013;8(1):e53934. doi: 10.1371/journal.pone.0053934. Epub 2013 Jan 9.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2027년 2월 1일
기본 완료 (추정된)
2031년 2월 1일
연구 완료 (추정된)
2031년 8월 31일
연구 등록 날짜
최초 제출
2026년 8월 25일
QC 기준을 충족하는 최초 제출
2026년 8월 25일
처음 게시됨 (실제)
2026년 8월 27일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 27일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 25일
마지막으로 확인됨
2026년 8월 1일
추가 정보
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