Mechanical Ventilation ComplicationNCT05550220
A Modified Cuff Leak Test and Reintubation in Mechanically Ventilated Patients
A study testing Cuff Leak Test in people with Mechanical Ventilation Complication and Weaning Failure, run by Beijing Chao Yang Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation Complication, Weaning Failure, Airway Obstruction
- What is being tested?
- Cuff Leak Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 586 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2022to 24 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- Oral endotracheal intubation and mechanical ventilation > 36 hours
- Fulfilled the weaning criteria
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Modified Cuff Leak Test and Reintubation in Mechanically Ventilated Patients: a Multicenter Randomised Controlled Trial
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.
Read the detailed description
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.
- Being tested
- Cuff Leak Test
- Medical subject headings
- Airway Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Cuff Leak Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48 hours
Secondary outcomes (6)
Reintubation within 48 hours after extubation
The incidence of reintubation within 48 hours after extubation in the ICU.
Measured: 48 hours
Post-extubation stridor
the occurrence of inspiratory stridor within 24 hours following tracheal extubation.
Measured: 24 hours
Invasive mechanical ventilation time before first extubation
Invasive mechanical ventilation time before first extubation
Measured: 28 days
length of ICU
the length of patient staying in intensive care unit
Measured: 90 days
length of hospital
the length of patient staying in hosptial
Measured: 90 days
required reintubation within 48 hours following extubation
The incidence of required reintubation within 48 hours after extubation in the ICU.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start1 Nov 2022
- Primary completion24 Mar 2024
- Study completion24 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mechanical Ventilation ComplicationStudies of the same condition, open and under way.
- More trials run by Beijing Chao Yang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 586 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bing Sun, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05550220
- Sponsor's protocol ID
- modified CLT
- Status last verified
- Mar 2024
- First submitted
- 19 Sep 2022
- Last updated
- 26 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39922534
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Modified Cuff Leak Test and Reintubation in Mechanically Ventilated Patients: a Multicenter Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05550220
- Acronym / sponsor ID
- modified CLT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 586 participants (actual)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 24 Mar 2024 (actual)
- Study completion
- 24 Mar 2024 (actual)
- First posted
- 22 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified Cuff Leak Test | Experimental | Diagnostic Test: Cuff Leak TestThe 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. |
| Usual Cuff Leak Test | Active comparator | Diagnostic Test: Cuff Leak TestThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years old
- Oral endotracheal intubation and mechanical ventilation > 36 hours
- Fulfilled the weaning criteria
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cuff Leak TestCuff 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. | Diagnostic test | Modified Cuff Leak Test, Usual Cuff Leak Test |
Primary outcome
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
6 secondary outcomes
Reintubation within 48 hours after extubation
Time frame: 48 hours
Post-extubation stridor
Time frame: 24 hours
Invasive mechanical ventilation time before first extubation
Time frame: 28 days
length of ICU
Time frame: 90 days
length of hospital
Time frame: 90 days
required reintubation within 48 hours following extubation
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Derived from this study: PubMed 39922534Tang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cuff Leak Test in people with Mechanical Ventilation Complication and Weaning Failure, run by Beijing Chao Yang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fulfilled predefined criteria indicating the need for reintubation within 48 hours following extubation (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05550220, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.