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Completed

NCT Number: NCT05550220

A Modified Cuff Leak Test and Reintubation in Mechanically Ventilated Patients

We hypothesized that the accuracy of the modified cuff leak test in predicting re-intubation in tracheal intubated patients is better than that of the conventional balloon leak test, thereby further reducing the re-intubation rate.

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Key information

Conditions

Mechanical Ventilation Complication Airway Obstruction Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Weaning Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bing Sun

Beijing, Beijing Municipality, 100020, China

About this study

The cuff leak test is an effective method for predicting the occurrence of upper airway obstruction in patients with endotracheal intubation after extubation, with high specificity and moderate sensitivity. However, there is still no clear and unified cuff leak test operation specification. A cohort study has proposed a modified method. When the patient is placed in a semi-recumbent position of 60 degrees and the ventilator is set to a low-flow square wave, it is more predictive than conventional methods. We hypothesized that the accuracy of the modified cuff leak test in predicting re-intubation in tracheal intubated patients is better than that of the conventional balloon leak test, thereby further reducing the re-intubation rate.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years old
  • Oral endotracheal intubation and mechanical ventilation > 36 hours
  • Fulfilled the weaning criteria

Exclusion criteria

  • The patient has a chest drainage tube and there is persistent air leak
  • Abnormalities of the larynx: such as tumors or vocal cord paralysis
  • The patient cannot maintain the semi-recumbent position
  • Unconventional weaning, such as awake ECMO, etc
  • Participated in the study during the hospitalization
  • Patients or their relatives refused written informed consent

Treatment and study plan

Cuff Leak Test

Diagnostic Test

Cuff leak test is a simple and convenient tool that can be used to predict upper-airway obstruction after extubation. The CLT is used to assess airway patency through listening for an air leak and observing changes in tidal volume (VT) after the cuff is deflated.

Primary outcomes

  1. fulfilled predefined criteria indicating the need for reintubation within 48 hours following extubation

    Time frame: 48 hours

    The incidence of fulfilled predefined criteria indicating the need for reintubation within 48 hours following extubation

Secondary outcomes

  1. Reintubation within 48 hours after extubation

    Time frame: 48 hours

    The incidence of reintubation within 48 hours after extubation in the ICU.

  2. Post-extubation stridor

    Time frame: 24 hours

    the occurrence of inspiratory stridor within 24 hours following tracheal extubation.

  3. Invasive mechanical ventilation time before first extubation

    Time frame: 28 days

    Invasive mechanical ventilation time before first extubation

  4. length of ICU

    Time frame: 90 days

    the length of patient staying in intensive care unit

  5. length of hospital

    Time frame: 90 days

    the length of patient staying in hosptial

  6. required reintubation within 48 hours following extubation

    Time frame: 48 hours

    The incidence of required reintubation within 48 hours after extubation in the ICU.

Other outcomes

  1. mortality of 90 days

    Time frame: 90 days

    mortality of 90 days

Sponsors and collaborators

Lead sponsor

Beijing Chao Yang Hospital

Other

Registry information

Official study title

A Modified Cuff Leak Test and Reintubation in Mechanically Ventilated Patients: a Multicenter Randomised Controlled Trial

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 22, 2022
Registry last updated
Mar 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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