Microaspiration and Endotracheal Tubes

NCT07017205 | Not Yet Recruiting DMC

• 1 other identifier: PRIISABA15678
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

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.

  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 (3)

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

  Intraoperative ( surgical procedure)

• Determine the incidence of post-extubation pain.

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

• Determine the incidence of post-extubation dysphonia.

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

Study Arms (2)

Conventional Cuff Pressure Control Group

ACTIVE COMPARATOR

Patients will be intubated by experienced anesthesiologists using a TaperGuard Evac tube (Covidien) with tapered cuff and subglottic suction system. Cuff inflation will be performed using the standard method commonly employed in clinical practice (passive recoil of syringe plunger).

Device: Application of oropharyngeal dye and tracheal aspirate collection

Continuous Cuff Pressure Control Group

EXPERIMENTAL

The intervention group will receive a TaperGuard Evac tube (Covidien) with tapered cuff and subglottic suction system, plus continuous cuff pressure monitoring using the Pressure Easy® device (Medtronic) to maintain 25-30 cmH₂O.

Device: Application of oropharyngeal dye and tracheal aspirate collection

Interventions

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.

Continuous Cuff Pressure Control Group; Conventional Cuff Pressure Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (\>18 years old) scheduled for surgery lasting at least one hour.
• ASA I-III classification.
• Signed informed consent.

You may not qualify if:

• 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.
• Elimination Criteria:
• Accidental extubation.
• Cardiorespiratory arrest or death.

Sponsors & Collaborators

• Argentinian Intensive Care Society: lead

Study Sites (1)

Hospital Britanico de Buenos Aires

CABA, Buenos Aires, 1280, Argentina

Location

Related Publications (3)

• Dullenkopf A, Gerber A, Weiss M. Fluid leakage past tracheal tube cuffs: evaluation of the new Microcuff endotracheal tube. Intensive Care Med. 2003 Oct;29(10):1849-53. doi: 10.1007/s00134-003-1933-6. Epub 2003 Aug 16.

  PMID: 12923620 BACKGROUND

• Lorente L, Lecuona M, Jimenez A, Lorenzo L, Roca I, Cabrera J, Llanos C, Mora ML. Continuous endotracheal tube cuff pressure control system protects against ventilator-associated pneumonia. Crit Care. 2014 Apr 21;18(2):R77. doi: 10.1186/cc13837.

  PMID: 24751286 BACKGROUND

• Blot SI, Poelaert J, Kollef M. How to avoid microaspiration? A key element for the prevention of ventilator-associated pneumonia in intubated ICU patients. BMC Infect Dis. 2014 Nov 28;14:119. doi: 10.1186/1471-2334-14-119.

  PMID: 25430629 BACKGROUND

Central Study Contacts

Gustavo A Plotnikow, BPT; BCs ICU; PhD(c)

CONTACT

+5491164543771; gplotnikow@hbritanico.com.ar

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: In addition to the participants, both the investigator responsible for patient randomization and the evaluator analyzing the samples for microaspiration will be blinded to group allocation. This double-masking approach is intended to minimize bias in both the allocation process and the outcome assessment.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Physical and Respiratory Care Department, ICU

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 12, 2025
• Study Start: February 1, 2026
• Primary Completion: April 30, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

AR (1)