Mode Of Ventilation During Critical IllnEss Pilot Trial

Respiratory Failure Clinical Trial

— MODE  

Official title:

Mode Of Ventilation During Critical Illness Pilot Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05563779
• Other study ID #: 220446
• Status: Completed
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: August 28, 2023

Study information

• Verified date: August 2023
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 566
• Est. completion date: August 28, 2023
• Est. primary completion date: August 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Other:
• Volume Control mode
Volume Control mode for mechanical ventilation
• Pressure Control mode
Pressure Control mode for mechanical ventilation
• Adaptive Pressure Control mode
Adaptive Pressure Control mode for mechanical ventilation

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Time from enrollment to initiation of assigned mode of mechanical ventilation (Feasibility Outcome)		Enrollment to 28 days
Other	Number of patients with a "Mode Modification Sheet" completed by treating clinicians (Feasibility Outcome)		Enrollment to 28 days
Other	Median daily exhaled tidal volume (mL/kg predicted body weight) on each study day (Exploratory Efficacy and Safety Outcome)		Enrollment to 7 days
Other	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
Other	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
Other	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
Other	Number of blood gas laboratory tests per day while receiving mechanical ventilation (Exploratory Safety and Efficacy Outcome)		Enrollment to 28 days
Other	Pneumomediastinum or pneumothorax during course of mechanical ventilation (Exploratory Efficacy and Safety Outcome)		Enrollment to 28 days
Other	SOFA score daily on the first 7 study days (Exploratory Safety and Efficacy Outcome)		Enrollment to 7 days
Other	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
Other	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
Other	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
Other	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
Primary	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