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Microaspiration and Endotracheal Tubes

NCT07017205 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2025-12-15

No results posted yet for this study

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.

Conditions

  • Endotracheal Tube Cuff
  • Microaspiration
  • Endotracheal Tube Cuff Pressure

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.

Sponsors & Collaborators

  • Argentinian Intensive Care Society

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2026-04-30
Completion
2026-05-31

Countries

  • Argentina

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07017205 on ClinicalTrials.gov