Vanderbilt Clinical Trials

Mode Of Ventilation During Critical IllnEss Pilot Trial

Purpose

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.

Condition

Respiratory Failure

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Crossover Assignment
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
Masking: Single (Outcomes Assessor)
Masking Description: Observer bias will be minimized by use of objective endpoints collected in duplicate by [1] study personnel blinded to group assignment and [2] automated data extraction from the electronic health record.

Arm Groups

Arm	Description	Assigned Intervention
Active Comparator Volume Control mode	During invasive mechanical ventilation in a study location, Volume Control will be used as the mode for continuous mandatory ventilation.	Other: Volume Control mode Volume Control mode for mechanical ventilation
Active Comparator Pressure Control mode	During invasive mechanical ventilation in a study location, Pressure Control will be used as the mode for continuous mandatory ventilation.	Other: Pressure Control mode Pressure Control mode for mechanical ventilation Other: Adaptive Pressure Control mode Adaptive Pressure Control mode for mechanical ventilation
Active Comparator Adaptive Pressure Control mode	During invasive mechanical ventilation in a study location, Adaptive Pressure Control will be used as the mode for continuous mandatory ventilation.	Other: Adaptive Pressure Control mode Adaptive Pressure Control mode for mechanical ventilation

More Details

Status: Completed
Sponsor: Vanderbilt University Medical Center

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.