Airway ExtubationNCT04356625
Maximum Expiratory Pressure in Induced Cough as a Predictor of Extubation Failure
A study testing MEPic in people with Airway Extubation, run by Hospital Nacional Profesor Alejandro Posadas at 1 site in Argentina.
Trial summary
Clinical trial for the evaluation of diagnostic tests. The sample was composed of adults under mechanical ventilation who passed the spontaneous breathing trial and was ready to be extubated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Airway Extubation
- What is being tested?
- MEPic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Oct 2018to 9 Sep 2019
- 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
- Under mechanical ventilation via endotracheal tube in a period greater than 48 hours
- Passing the spontaneous breathing trial an be ready for extubation.
- Agree to participate in the study and sign the informed consent by the patient or family member
Who cannot join
- tracheostomized prior to admission to mechanical ventilation
- history of neuromuscular disease
- presence of unstable heart disease
- received upper digestive surgery
- presence of uncontained enterocutaneous fistula
- candidates for non-invasive ventilation as a modality of interface exchange for extubation or as a preventive modality
- patients who did not reach a MEP (habitual) of 30 cmH20 since they are not extubated by the extubation protocol of our institution.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Maximum Expiratory Pressure in Induced Cough as a Predictor of Extubation Failure in Intensive Care Unit Patients on Mechanical Ventilation Ready to Extubate. A Single-arm Open Clinical Trial.
Clinical trial for the evaluation of diagnostic tests. The sample was composed of adults under mechanical ventilation who passed the spontaneous breathing trial and was ready to be extubated. The maximum expiratory pressure measured in the usual way and the maximum expiratory pressure generated during the induced cough were taken as predictor variables. The outcome variable was extubation failure, measured at 72 hours and at 7 days.
Read the detailed description
After completing the spontaneous breathing trial (SBT), with the extubation decision defined by the physician in charge of the patient and maximal expiratory pressure (MEP) as usually measured greater than 30 centimeters of water (cmH2O). Following this, the patient was allowed to rest for 5 minutes in the same condition. With the patient in the supine position sitting 45 ° to 60 °, the closed suction catheter was removed, an elbow was placed at 90 ° and a bacterial filter in series with the endotracheal tube (ET), an adapter was also coupled with a outlet port to the aneroid pressure gauge. In series an inspiratory unidirectional valve was placed that did not allow expiration. Immediately 2 ml of physiological solution was slowly instilled through the port in the 90º elbow to trigger the cough reflex. The presence or absence of reflex cough and the MEP during induced cough (MEPic) value were verified.
As a safety method, the procedures were stopped if the patient presented signs of intolerance such as respiratory rate (RF)> 35 breaths per minute, saturation <90%, heart rate (HR)> 140 beats per minute or increase of 20 % of resting levels.
- Conditions
- Airway Extubation
- Being tested
- MEPic
- Keywords
- airway extubation, maximal expiratory pressure, induced cough, ventilator weaning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEPicDiagnostic test
- patient in the supine position sitting 45° to 60°,
- closed suction catheter was removed
- a 90° elbow was placed and a bacterial filter in series with endotracheal tube
- adapter was also coupled to the aneroid pressure gauge
- in series an inspiratory unidirectional valve was placed that did not allow expiration
- 2 ml of physiological solution was slowly instilled through the port in the 90º elbow to cause induced cough
| Study group | Role | What they receive |
|---|---|---|
| MEPic | Other | * Ready for extubation (pass SBT)
* Measurement of maximum expiratory pressure during the induced cough (MEPic) Receives: Diagnostic Test: MEPic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extubation failure
Endotracheal tube removal failure
Measured: 72 hours
Extubation failure
Endotracheal tube removal failure
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start1 Oct 2018
- Primary completion1 Sep 2019
- Study completion9 Sep 2019
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 Airway ExtubationStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm clinical trial to establish diagnostic performance of MEPic
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Nacional Profesor Alejandro Posadas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ladislao P Diaz-Ballve, Lic., Principal investigator, Hospital Nacional Profesor Alejandro Posadas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04356625
- Sponsor's protocol ID
- 209LUP0S0/18
- Status last verified
- Apr 2020
- First submitted
- 20 Apr 2020
- Last updated
- 4 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carrera M, Urrutia JG, Ardariz CB, Porra ML, Gamarra C, Ballve LPD. Maximal expiratory pressure compared with maximal expiratory pressure during induced cough as a predictor of extubation failure. Crit Care Sci. 2023 Mar 1;35(1):37-43. doi: 10.5935/2965-2774.20230275-en.
PubMed 37712728
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maximum Expiratory Pressure in Induced Cough as a Predictor of Extubation Failure in Intensive Care Unit Patients on Mechanical Ventilation Ready to Extubate. A Single-arm Open Clinical Trial.
- ClinicalTrials.gov ID
- NCT04356625
- Acronym / sponsor ID
- 209LUP0S0/18
- Conditions
- Airway Extubation
- Keywords
- airway extubation, maximal expiratory pressure, induced cough, ventilator weaning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hospital Nacional Profesor Alejandro PosadasUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 9 Sep 2019 (actual)
- First posted
- 22 Apr 2020 (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.
Clinical trial for the evaluation of diagnostic tests. The sample was composed of adults under mechanical ventilation who passed the spontaneous breathing trial and was ready to be extubated. The maximum expiratory pressure measured in the usual way and the maximum expiratory pressure generated during the induced cough were taken as predictor variables. The outcome variable was extubation failure, measured at 72 hours and at 7 days.
Detailed description
After completing the spontaneous breathing trial (SBT), with the extubation decision defined by the physician in charge of the patient and maximal expiratory pressure (MEP) as usually measured greater than 30 centimeters of water (cmH2O). Following this, the patient was allowed to rest for 5 minutes in the same condition. With the patient in the supine position sitting 45 ° to 60 °, the closed suction catheter was removed, an elbow was placed at 90 ° and a bacterial filter in series with the endotracheal tube (ET), an adapter was also coupled with a outlet port to the aneroid pressure gauge. In series an inspiratory unidirectional valve was placed that did not allow expiration. Immediately 2 ml of physiological solution was slowly instilled through the port in the 90º elbow to trigger the cough reflex. The presence or absence of reflex cough and the MEP during induced cough (MEPic) value were verified.
As a safety method, the procedures were stopped if the patient presented signs of intolerance such as respiratory rate (RF)> 35 breaths per minute, saturation <90%, heart rate (HR)> 140 beats per minute or increase of 20 % of resting levels.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm clinical trial to establish diagnostic performance of MEPic
| Arm | Type | Receives |
|---|---|---|
| MEPic | Other | Diagnostic Test: MEPic* Ready for extubation (pass SBT) * Measurement of maximum expiratory pressure during the induced cough (MEPic) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Under mechanical ventilation via endotracheal tube in a period greater than 48 hours
- Passing the spontaneous breathing trial an be ready for extubation.
- Agree to participate in the study and sign the informed consent by the patient or family member
Key exclusion criteria (7 listed)
- tracheostomized prior to admission to mechanical ventilation
- history of neuromuscular disease
- presence of unstable heart disease
- received upper digestive surgery
- presence of uncontained enterocutaneous fistula
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 |
|---|---|---|
| MEPic* patient in the supine position sitting 45° to 60°, * closed suction catheter was removed * a 90° elbow was placed and a bacterial filter in series with endotracheal tube * adapter was also coupled to the aneroid pressure gauge * in series an inspiratory unidirectional valve was placed that did not allow expiration * 2 ml of physiological solution was slowly instilled through the port in the 90º elbow to cause induced cough | Diagnostic test | MEPic |
Primary outcome
Extubation failure
Time frame: 72 hours
Endotracheal tube removal failure
Extubation failure
Time frame: 7 days
Endotracheal tube removal failure
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 4 May 2020.
- Derived from this study: PubMed 37712728Carrera M, Urrutia JG, Ardariz CB, Porra ML, Gamarra C, Ballve LPD. Maximal expiratory pressure compared with maximal expiratory pressure during induced cough as a predictor of extubation failure. Crit Care Sci. 2023 Mar 1;35(1):37-43. doi: 10.5935/2965-2774.20230275-en.
- Individual participant dataSharing planned: No
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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.
Ladislao P Diaz-Ballve, Lic. principal investigator
Hospital Nacional Profesor Alejandro Posadas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MEPic in people with Airway Extubation, run by Hospital Nacional Profesor Alejandro Posadas at 1 site in Argentina.
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 7 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 4 May 2020. 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 Argentina. 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?
Extubation failure (time frame: 72 hours). The study lists 2 primary outcomes in all. 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 NCT04356625, 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 4 May 2020.