Deflated and Inflated Cuff Endotracheal Extubations

NAEnrolling by invitationINTERVENTIONAL
Enrollment

88

Participants

Timeline

Start Date

June 30, 2025

Primary Completion Date

September 30, 2026

Study Completion Date

September 30, 2026

Conditions
Randomized Controlled TrialAirway ContaminationDeflated Cuff ExtubationInflated Cuff ExtubationRespiratory ComplicationsLaryngeal Complications
Interventions
PROCEDURE

Inflated Cuff Extubation

The adjustable pressure limiting valve will be set to 20 centimeters water pressure. To blind the Anesthesiologist Associate Investigator from the patient's group allocation, sham deflation of the endotracheal tube cuff pilot balloon will be performed with a 10 milliliter syringe. The endotracheal tube will be withdrawn into an opaque blue towel while the reservoir bag is simultaneously compressed to generate at least 20 centimeters water pressure positive airway pressure. In the rare event significant resistance is met with attempted extubation, the principal investigator will deflate the cuff in one milliliter increments until extubation is possible. This process does not unblind the Anesthesiologist Associate Investigator.

PROCEDURE

Deflated Cuff Extubation

The adjustable pressure-limiting valve will be set to 20 centimeters water pressure. All air will be removed from the endotracheal tube cuff pilot balloon with a 10 milliliter syringe. The endotracheal tube will be withdrawn into an opaque blue towel, to prevent the Anesthesiologist Associate Investigator from identifying the patient's allocation, while the reservoir bag is simultaneously compressed to generate at least 20 centimeters water pressure positive airway pressure.

Trial Locations (1)

28547

Naval Medical Center Camp Lejeune, Marine Corps Base Camp Lejeune

All Listed Sponsors
lead

Naval Medical Center Camp Lejeune

FED