NCT05550220

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
586

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 22, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2024

Completed
Last Updated

March 26, 2024

Status Verified

March 1, 2024

Enrollment Period

1.4 years

First QC Date

September 19, 2022

Last Update Submit

March 24, 2024

Conditions

Mechanical Ventilation ComplicationWeaning FailureAirway Obstruction

Outcome Measures

Primary Outcomes (1)

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

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

    48 hours

Secondary Outcomes (6)

  • Reintubation within 48 hours after extubation

    48 hours

  • Post-extubation stridor

    24 hours

  • Invasive mechanical ventilation time before first extubation

    28 days

  • length of ICU

    90 days

  • length of hospital

    90 days

  • +1 more secondary outcomes

Other Outcomes (1)

  • mortality of 90 days

    90 days

Study Arms (2)

Modified Cuff Leak Test

EXPERIMENTAL

The subject was placed in a semi-recumbent position. The subjects were placed in volume assist-control mode with the following parameters: * respiratory rate 15 breaths/min * original oxygen concentration * PEEP 0 cm H2O * the VT was set according to the subject's stable VT in the previous ventilator mode * inspiratory flow was set at 30 L/min with square waveform Positive cutoff value of the air leak volume was 116 mL and the air leak ratio was 0.32.

Diagnostic Test: Cuff Leak Test

Usual Cuff Leak Test

ACTIVE COMPARATOR

The subjects were placed in volume assist-control mode with the following parameters: * respiratory rate was adapted to patient comfort * original oxygen concentration and PEEP * the VT about 8ml/Kg IBW * inspiratory flow was set at 60 L/min with square waveform Positive cutoff value of the air leak volume was 110 mL and the air leak ratio was 0.15.

Diagnostic Test: Cuff Leak Test

Interventions

Cuff Leak TestDIAGNOSTIC_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.

Modified Cuff Leak TestUsual Cuff Leak Test

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bing Sun

Beijing, Beijing Municipality, 100020, China

Location

Related Publications (1)

  • Tang X, Gu YM, Shi Y, Li ZM, Cao R, Lu SG, Wu YB, Tao YF, Sun ZY, Yin YJ, Liu CY, Tang XB, Gan GF, Qin XJ, Yin D, Zhao HB, Liu CY, Zhang L, Fang P, Du LS, Li L, Tan H, Li M, Zuo YT, Sun B; Chao-Yang Mechanical Ventilation Study Collaboration Group. Modified Cuff Leak Test for Predicting the Risk of Reintubation in Patients With Invasive Mechanical Ventilation: A Multicenter, Single-Anonymized, Randomized Controlled Trial. Chest. 2025 Jul;168(1):119-130. doi: 10.1016/j.chest.2025.01.033. Epub 2025 Feb 6.

    PMID: 39922534DERIVED

MeSH Terms

Conditions

Airway Obstruction

Condition Hierarchy (Ancestors)

Respiratory InsufficiencyRespiration DisordersRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor of treatment

Study Record Dates

First Submitted

September 19, 2022

First Posted

September 22, 2022

Study Start

November 1, 2022

Primary Completion

March 24, 2024

Study Completion

March 24, 2024

Last Updated

March 26, 2024

Record last verified: 2024-03

Locations

CN(1)