Mode Of Ventilation During Critical IllnEss Pilot Trial (MODE)

Mode Of Ventilation During Critical Illness Pilot Trial

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Failure
• Intervention / Treatment: Other: Volume Control mode; Other: Pressure Control mode; Other: Adaptive Pressure Control mode

• Study Type: Interventional
• Enrollment (Actual): 566
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kevin P. Seitz, MD, MSc; Phone Number: (615) 322-3412; Email: kevin.seitz@vumc.org

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ventilator-free days (VFDs) to day 28 after enrollment	Number of days alive and free from invasive mechanical ventilation between the final liberation from invasive mechanical ventilation before 28 days and study day 28. Patients who continue to receive invasive mechanical ventilation at day 28 or have died prior to day 28 will receive zero VFDs. For patients who return to invasive mechanical ventilation and are subsequently liberated from invasive mechanical ventilation prior to day 28, VFDs will be counted from final liberation from mechanical ventilation.	Enrollment to 28 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from enrollment to initiation of assigned mode of mechanical ventilation (Feasibility Outcome)		Enrollment to 28 days
Number of patients with a "Mode Modification Sheet" completed by treating clinicians (Feasibility Outcome)		Enrollment to 28 days
Severe acidemia during mechanical ventilation (Exploratory Safety and Efficacy Outcome)	Episodes of severe acidemia during mechanical ventilation: pH < 7.1 on blood gas	Enrollment to 28 days
Number of blood gas laboratory tests per day while receiving mechanical ventilation (Exploratory Safety and Efficacy Outcome)		Enrollment to 28 days
Pneumomediastinum or pneumothorax during course of mechanical ventilation (Exploratory Efficacy and Safety Outcome)		Enrollment to 28 days
SOFA score daily on the first 7 study days (Exploratory Safety and Efficacy Outcome)		Enrollment to 7 days
Delirium and coma free days to day 28 (Exploratory Efficacy and Safety Outcome)	Number of days alive and without delirium or coma before 28 days to study day 28	Enrollment to 28 days
Intensive care unit-free days to study day 28 (Exploratory Clinical Outcome)	Number of days alive and free from intensive care unit admission after the final transfer out of the intensive care unit before 28 days to study day 28	Enrollment to 28 days
Hospital-Free days to study day 28 (Exploratory Clinical Outcome)	Number of days alive and free from hospitalization after the final transfer out of the hospital before 28 days to study day 28	Enrollment to 28 days
In-hospital mortality to study day 28 (Exploratory Clinical Outcome)	All-cause mortality prior to discharge from the hospital, assessed at 28 days after enrollment	Enrollment to 28 days
Exposure to assigned study mode in first 3 days (Feasibility Outcome)	Proportion of time in the assigned mode while receiving invasive mechanical ventilation in the study ICU between enrollment and 72 hours after enrollment	Enrollment to 72 hours
Adherence to study mode in first 3 days (Feasibility Outcome)	Proportion of time in the assigned mode while receiving invasive mechanical ventilation in the study ICU with a mandatory mode between enrollment and 72 hours after enrollment (excluding time spent in spontaneous modes)	Enrollment to 72 hours
Median daily exhaled tidal volume (mL/kg predicted body weight) on each study day (Exploratory Efficacy and Safety Outcome)		Enrollment to 7 days
Exhaled tidal volumes above target range (Exploratory Efficacy and Safety Outcome)	Proportion of recorded breaths with exhaled tidal volume values above target range (>8mL/kg predicted body weight) on each study day	Enrollment to 7 days
Hypoxemia during mechanical ventilation (Exploratory Safety and Efficacy Outcome)	Episodes of hypoxemia during mechanical ventilation: SpO2 <85% for more than 5 minutes	Enrollment to 28 days

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Kevin P. Seitz, MD, MSc, Clinical Fellow

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): August 28, 2023
• Study Completion (Actual): August 28, 2023

Study Registration Dates

• First Submitted: September 28, 2022
• First Submitted That Met QC Criteria: September 28, 2022
• First Posted (Actual): October 3, 2022

Study Record Updates

• Last Update Posted (Estimated): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Disease Attributes; Respiratory Insufficiency; Critical Illness
• Other Study ID Numbers: 220446

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported will be made available (including data dictionaries) after de-identification.
• IPD Sharing Time Frame: The data will become available 3 months following publication of primary trial results and will remain available for at least 5 years.

IPD Sharing Access Criteria

Following publication, individual patient data will be made available for sharing to researchers with 1) a signed data access agreement, 2) research testing a hypothesis, 3) a protocol that has been approved by an institutional review board, and 4) a proposal that has received approval from the principal investigator.

Even though the final dataset will be stripped of identifiers prior to release for sharing, the inherent link between the period in which the patient was admitted to the study ICU and group assignment in a cluster-crossover trial introduces a significant risk for deductive disclosure of subjects. Thus, we will make the data available to users only under a data sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No