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NOT YET RECRUITING
NCT07017205
NA

Microaspiration and Endotracheal Tubes

Sponsor: Argentinian Intensive Care Society

View on ClinicalTrials.gov

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.

Official title: Automated Versus Manual Cuff Pressure Control for Preventing Microaspiration With TaperGuard Endotracheal Tubes in Elective Surgery: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

72

Start Date

2026-02-01

Completion Date

2026-05-31

Last Updated

2025-12-15

Healthy Volunteers

No

Interventions

DEVICE

Application of oropharyngeal dye and tracheal aspirate collection

After intubation, 2 mL of blue dye will be applied to the oropharyngeal mucosa. Once hemodynamically stable (MAP \>65 mmHg), the first tracheal aspirate will be collected within 10 minutes by a blinded investigator for analysis.

Locations (1)

Hospital Britanico de Buenos Aires

CABA, Buenos Aires, Argentina