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Microaspiration and Endotracheal Tubes

ConditionsEndotracheal Tube CuffMicroaspirationEndotracheal Tube Cuff Pressure
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorArgentinian Intensive Care Society

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients (>18 years old) scheduled for surgery lasting at least one hour.

ASA I-III classification.

Signed informed consent.

Disqualifiers

Pre-existing airway pathology (e.g., tracheomalacia, granulomas, stenosis, tumors).

Anticipated difficult intubation (Macocha Score > 3 points).

Selective lung ventilation / one-lung ventilation.

Current participation in another clinical trial.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Application of oropharyngeal dye and tracheal aspirate collection

    Device

    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.

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: Conventional Cuff Pressure Control GroupActive comparator 1 intervention
Group B: Continuous Cuff Pressure Control GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Penetration of blue-dyed oropharyngeal secretions into the distal airway

Evaluate the penetration of blue-dyed oropharyngeal secretions into the distal airway in patients undergoing orotracheal intubation.

Time frame
From enrollment to the end of Surgery: Tracheal aspirate samples will be collected at two defined time points: the first between 10 and 30 minutes after intubation and hemodynamic stabilization, and the second immediately prior to extubation.

Secondary outcomes

1

Real-time changes in endotracheal tube cuff pressure during the surgical procedure

Cuff pressure monitoring will be performed at predefined intervals. In the experimental group, continuous cuff pressure monitoring will be conducted using the Pressure Easy® Cuff Pressure Controller. In the control group, cuff pressure will be manually regulated with a manovacuometer, using the syringe-backflow method to adjust pressure.

Time frame
Intraoperative ( surgical procedure)
2

Determine the incidence of post-extubation pain.

Post extubation pain evaluated using the verbal numerical rating scale (0-10).

Time frame
The pain will be assessed at the following post-extubation time points: 1 hour, 2 hours, 3 hours, and 24 hours.
3

Determine the incidence of post-extubation dysphonia.

Post-extubation dysphonia: Assessed using the GRBAS (Grade, Roughness, Breathiness, Asthenia, Strain) clinical scale, with the grade aspect scored from 0 to 3.

Time frame
These dysphonia will be assessed at the following post-extubation time points: 1 hour, 2 hours, 3 hours, and 24 hours.

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Hospital Britanico de Buenos Aires Status unavailable 1280, CABA, Buenos AiresArgentinaArgentina

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Argentinian Intensive Care Society

Lead sponsor

HOSPITAL BRITANICO DE BUENOS AIRES

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: