Mode of Ventilation During Critical Illness at Multiple Centers

N/AEnrolling By InvitationNCT07313956

Vanderbilt University Medical Center4,785 enrolled

Overview

The goal of this clinical trial is to learn whether the choice of ventilator mode for patients on breathing machines in the intensive care unit affects their survival and recovery. To do this, researchers will assign the entire participating intensive care unit to one of the three available ventilator modes, alternating which mode is assigned in random sequence every 2 months. The main question it aims to answer is: Does the choice between volume control, pressure control, and adaptive pressure control affect the number of days that patients are alive and free of the breathing machine?

The MODEM trial is a cluster-randomized, cluster-crossover clinical trial comparing the effectiveness of three ventilator modes (volume control vs pressure control vs adaptive pressure control) for mechanical ventilation of critically ill adults at multiple centers. A total of 4,785 critically ill adults receiving invasive mechanical ventilation in intensive care units will be enrolled and included in the primary analysis. Each study unit will be assigned to a ventilator mode and will switch between modes every 2 months in an order determined by randomization. Enrolled patients will be assigned to receive volume control, pressure control, or adaptive pressure control according to the mode assigned to the unit at the time they were enrolled. The primary outcome will be ventilator-free days in the first 28 days, and the secondary outcome will be all-cause, 28-day in-hospital mortality.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

4,785

Conditions

Respiratory Failure

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient is receiving mechanical ventilation through an endotracheal tube or tracheostomy * Patient is physically located in a participating adult ICU Exclusion Criteria: * Patient is known to be less than 18 years old * Patient is known to be a prisoner * Patient is known to have been receiving invasive mechanical ventilation at place of residence prior to hospital admission * Patient is receiving extracorporeal membrane oxygenation at the time when inclusion criteria are first met

Locations (4)

Rush University Medical Center

Chicago, Illinois, United States

The Johns Hopkins Hospital

Baltimore, Maryland, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

Ventilator-free days in the first 28 days

The number of calendar days between enrollment and 28 days after enrollment, on which the patient is alive and free of invasive mechanical ventilation. Receipt of invasive mechanical ventilation will be considered to end when patients undergo the final tracheal extubation or disconnection of the ventilator from a tracheostomy tube between enrollment and day 28.

Time frame: From enrollment to 28 days after enrollment

Secondary Outcomes

All-cause, 28-day, in-hospital mortality

All-cause, 28-day, in-hospital mortality, defined as death from any cause occurring between enrollment and 28 days after enrollment with outcome ascertainment ending at hospital discharge.