The Variable Ventilation Trial (Part A)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorBrigham and Women's Hospital
About this trial
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:
1. Is variable ventilation safe to use in adults with ARDS? 2. 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Age less than 21 years
Pregnant or breastfeeding
Prisoner
Concurrent participation in another investigational drug study
Trial design
Design model
Sequential
Treatments tested in this trial
Variable Ventilation
DeviceStrategy of mechanical ventilation based on varying tidal volume breath to breath to provide therapeutic benefits in patients with ARDS.
Conventional Ventilation
DeviceStrategy of mechanical ventilation based on delivery of a constant size low tidal volume.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Variable VentilationExperimental treatment 1 intervention
Group B: Conventional VentilationPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Safety assessed by the incidence of pre-specified AEs over the first 24 hours
Barotrauma
Time frame
Maximum of 24 hours of VV2
Safety assessed by the incidence of pre-specified AEs over the first 24 hours
Worsening Hypoxemia
Time frame
Maximum of 24 hours of VV3
Safety assessed by the incidence of pre-specified AEs over the first 24 hours
Worsening ventilation
Time frame
Maximum of 24 hours of VV4
Safety assessed by the incidence of pre-specified AEs over the first 24 hours
New onset arrhythmia requiring cardioversion
Time frame
Maximum of 24 hours of VVSecondary outcomes
1
Lung mechanics
Lung compliance, airways resistance, peak and plateau pressures
Time frame
Every 12 hours to maximum of 24 hours of VV2
Gas exchange
SpO2, PaO2/FiO2 ratio, oxygenation index, dead space, and lung injury score.
Time frame
Every 12 hours to maximum of 24 hours of VV3
Feasibility of VV implementation.
Qualitative feedback from Research and Clinical staff of the device and implementation in the ICU setting.
Time frame
Every 12 hours during 24 hours of VVSponsors and contacts
Click on the lead sponsor to view all of their trials.
Brigham and Women's Hospital
Lead sponsor
Baystate Medical Center
Collaborator
Boston University
Collaborator
Oregon Health and Science University
Collaborator
University of Alabama at Birmingham
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: