Adaptive Pressure Control mode for Respiratory Failure

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Respiratory FailureAdaptive Pressure Control mode - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

Landmark trials in critical care have demonstrated that, among critically ill adults receiving invasive mechanical ventilation, the use of low tidal volumes and low airway pressures prevents lung injury and improves patient outcomes. Limited evidence, however, informs the best method of mechanical ventilation to achieve these targets. To provide mechanical ventilation, clinicians must choose between modes of ventilation that directly control tidal volumes ("volume control"), modes that directly control the inspiratory airway pressure ("pressure control"), and modes that are hybrids ("adaptive pressure control"). Whether the choice of the mode used to target low tidal volumes and low inspiratory plateau pressures affects clinical outcomes for critically ill adults receiving mechanical ventilation is unknown. All three modes of mechanical ventilation are commonly used in clinical practice. A large, multicenter randomized trial comparing available modes of mechanical ventilation is needed to understand the effect of each mode on clinical outcomes. The investigators propose a 9-month cluster-randomized cluster-crossover pilot trial evaluating the feasibility of comparing three modes (volume control, pressure control, and adaptive pressure control) for mechanically ventilated ICU patients with regard to the outcome of days alive and free of invasive mechanical ventilation.

Eligible Conditions
  • Respiratory Failure

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: Enrollment to 72 hours

Enrollment to 28 days
Delirium and coma free days to day 28 (Exploratory Efficacy and Safety Outcome)
Hospital-Free days to study day 28 (Exploratory Clinical Outcome)
Hypoxemia during mechanical ventilation (Exploratory Safety and Efficacy Outcome)
In-hospital mortality to study day 28 (Exploratory Clinical Outcome)
Intensive care unit-free days to study day 28 (Exploratory Clinical Outcome)
Number of blood gas laboratory tests per day while receiving mechanical ventilation (Exploratory Safety and Efficacy Outcome)
Number of patients with a "Mode Modification Sheet" completed by treating clinicians (Feasibility Outcome)
Pneumomediastinum or pneumothorax during course of mechanical ventilation (Exploratory Efficacy and Safety Outcome)
Severe acidemia during mechanical ventilation (Exploratory Safety and Efficacy Outcome)
Mechanical ventilation
Ventilator-free days (VFDs) to day 28 after enrollment
Enrollment to 7 days
Exhaled tidal volumes above target range (Exploratory Efficacy and Safety Outcome)
Median daily exhaled tidal volume on each study day (Exploratory Efficacy and Safety Outcome)
SOFA score daily on the first 7 study days (Exploratory Safety and Efficacy Outcome)
Enrollment to 72 hours
Adherence to study mode in first 3 days (Feasibility Outcome)
Exposure to assigned study mode in first 3 days (Feasibility Outcome)

Trial Safety

Trial Design

3 Treatment Groups

Adaptive Pressure Control mode
1 of 3
Volume Control mode
1 of 3
Pressure Control mode
1 of 3

Active Control

606 Total Participants · 3 Treatment Groups

Primary Treatment: Adaptive Pressure Control mode · No Placebo Group · N/A

Adaptive Pressure Control mode
Other
ActiveComparator Group · 1 Intervention: Adaptive Pressure Control mode · Intervention Types: Other
Volume Control mode
Other
ActiveComparator Group · 1 Intervention: Volume Control mode · Intervention Types: Other
Pressure Control mode
Other
ActiveComparator Group · 1 Intervention: Pressure Control mode · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: enrollment to 72 hours

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
774 Previous Clinical Trials
600,511 Total Patients Enrolled
3 Trials studying Respiratory Failure
2,948 Patients Enrolled for Respiratory Failure
Kevin P. Seitz, MD, MScPrincipal InvestigatorClinical Fellow

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are receiving mechanical ventilation through an endotracheal tube or tracheostomy.