Clinical Trial

Microaspiration and Endotracheal Tubes

Not Yet Recruiting
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Record status
This record was last updated December 15, 2025 (before its estimated April 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
The goal of this clinical trial is to learn if a new method for managing breathing tube pressure is better at preventing fluid from leaking into patients' lungs during surgery. It will also check if it causes fewer side effects like a sore throat. The main questions it aims to answer are: Does using a continuous pressure controller reduce fluid leakage past the breathing tube cuff compared to the standard manual method? Does the continuous pressure controller lead to fewer and less severe sore throats and voice changes after surgery? Researchers will compare two groups: Group 1: Patients whose breathing tube cuff pressure is managed with a continuous automatic controller. Group 2: Patients whose breathing tube cuff pressure is managed with the standard manual method. Participants will: Be randomly assigned to one of the two groups before their surgery. Receive a small, safe amount of blue dye in their mouth during the procedure to help measure leakage. Have two small secretion samples collected from their breathing tube during surgery. Be asked about sore throat and voice changes at 1, 2, 3, and 24 hours after the breathing tube is removed.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-06-04; most recent amendment 2025-12-05.
Trial Details
NCT Number NCT07017205
Lead Sponsor Argentinian Intensive Care Society
Conditions Endotracheal Tube Cuff, Microaspiration, Endotracheal Tube Cuff Pressure
Enrollment 72 participants
Start Date 2026-02-01
Primary Completion 2026-04-30 (estimated)
Study Completion 2026-05-31 (estimated)
Updated on ClinicalTrials.gov 2025-12-15