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A Single-center, Prospective Study for Mechanism and Risk Factors of Tracheal Tube-related Tongue Injury

NCT05987293 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 94

Last updated 2024-11-18

No results posted yet for this study

Summary

Article Summary

1. Tracheal tube-related tongue injury is a common clinical complication that would lead to serious events such as dysphagia, respiratory dysfuncion and macroglossia.
2. There is a lack of qualitative and quantitative risk assessment of tracheal tube-related tongue injury.
3. This is a protocol of a single-center, prospective, paralled-group clinical trial based on the measurement of dynamic changes in pressure between the tracheal tube and the tongue in different position during the surgery.
4. The primary endpoint is tracheal tube-related tongue injury, secondary outcomes include the time to first successful recovery of oral intake of fluids and solid food and airway-related events.
5. This trial aims to find the best indicators for tracheal tracheal tube-related tongue injury and to provide solid basis for optimizing airway protection strategies and surgical positioning.

Conditions

  • Tracheal Tube-related Tongue Injury

Interventions

DEVICE

Tracheal tube-tongue pressure is measured using a computerized occlusal analysis system based on T-Scan® technique, suitable for multi-point real-time monitoring of intraoral pressure.

A flexible film sensor with a thickness of 0.11mm is placed between the tongue and the tracheal tube to measure the distribution, join force and dynamic changes of pressure at different site of the tongue. Five channels of pressure values will be recorded separately: (Ch1) the tip of the tongue, (Ch2) the middle of the tongue, (Ch3) the base of the tongue, (Ch4) the right side at the base of the tongue, (Ch5) the left side at the base of the tongue. The pressure values at the following points during the operation will be recorded: (t1) after intubation, (t2) highest pressure during patient positioning, (t3) after position fixed, (t4) at the end of surgery, (t5) before extubation.

Sponsors & Collaborators

  • China-Japan Friendship Hospital

    lead OTHER

Principal Investigators

  • Wei Xia Li, MD · China-Japan Friendship Hospital

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-19
Primary Completion
2024-08-20
Completion
2025-12-31

Countries

  • China

Study Locations

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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 NCT05987293 on ClinicalTrials.gov