Clinical trial NCT05563779: Mode Of Ventilation During Critical IllnEss Pilot Trial
Official title: Mode Of Ventilation During Critical Illness Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Failure
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2022-10-03
Enrollment: 566
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: In the MODE trial, the entire study ICU will be assigned to a single mode for continuous mandatory ventilation and the ICU will switch between volume control, pressure control, and adaptive pressure control every month in a randomly generated sequence (cluster-crossover).
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Receiving mechanical ventilation through an endotracheal tube or tracheostomy
* Admitted to the study ICU

Exclusion Criteria:

* Patient is pregnant
* Patient is a prisoner
* Patient receiving invasive mechanical ventilation at place of residence prior to hospital admission
* Patient receiving extracorporeal membrane oxygenation at the time of admission to the study ICU

Primary outcomes:
measure: Ventilator-free days (VFDs) to day 28 after enrollment
timeFrame: Enrollment to 28 days
Secondary outcomes:
Other outcomes:
measure: Exposure to assigned study mode in first 3 days (Feasibility Outcome)
timeFrame: Enrollment to 72 hours
measure: Adherence to study mode in first 3 days (Feasibility Outcome)
timeFrame: Enrollment to 72 hours
measure: Time from enrollment to initiation of assigned mode of mechanical ventilation (Feasibility Outcome)
timeFrame: Enrollment to 28 days
measure: Number of patients with a "Mode Modification Sheet" completed by treating clinicians (Feasibility Outcome)
timeFrame: Enrollment to 28 days
measure: Median daily exhaled tidal volume (mL/kg predicted body weight) on each study day (Exploratory Efficacy and Safety Outcome)
timeFrame: Enrollment to 7 days
measure: Exhaled tidal volumes above target range (Exploratory Efficacy and Safety Outcome)
timeFrame: Enrollment to 7 days
measure: Hypoxemia during mechanical ventilation (Exploratory Safety and Efficacy Outcome)
timeFrame: Enrollment to 28 days
measure: Severe acidemia during mechanical ventilation (Exploratory Safety and Efficacy Outcome)
timeFrame: Enrollment to 28 days
measure: Number of blood gas laboratory tests per day while receiving mechanical ventilation (Exploratory Safety and Efficacy Outcome)
timeFrame: Enrollment to 28 days
measure: Pneumomediastinum or pneumothorax during course of mechanical ventilation (Exploratory Efficacy and Safety Outcome)
timeFrame: Enrollment to 28 days
measure: SOFA score daily on the first 7 study days (Exploratory Safety and Efficacy Outcome)
timeFrame: Enrollment to 7 days
measure: Delirium and coma free days to day 28 (Exploratory Efficacy and Safety Outcome)
timeFrame: Enrollment to 28 days
measure: Intensive care unit-free days to study day 28 (Exploratory Clinical Outcome)
timeFrame: Enrollment to 28 days
measure: Hospital-Free days to study day 28 (Exploratory Clinical Outcome)
timeFrame: Enrollment to 28 days
measure: In-hospital mortality to study day 28 (Exploratory Clinical Outcome)
timeFrame: Enrollment to 28 days
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Clinical Fellow
name: Kevin P. Seitz, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: