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CompletedNCT04356625Updated May 4, 2020

Maximum Expiratory Pressure in Induced Cough as a Predictor of Extubation Failure

An interventional study of MEPic in Airway Extubation, sponsored by Hospital Nacional Profesor Alejandro Posadas. Completed at 1 site in Argentina. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-04.

Sponsored by Hospital Nacional Profesor Alejandro Posadas · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Oct 2018, registered Apr 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Airway Extubation

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Keywords

  • airway extubation
  • maximal expiratory pressure
  • induced cough
  • ventilator weaning
03

In context

Cough

346 studies on the registry are indexed under Cough; 71 are open to participants now.

This study's enrollment of 80 is above the median of 70 across 263 interventional studies indexed under Cough.

Browse Cough studies →

Lead sponsor

Hospital Nacional Profesor Alejandro Posadas is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
80 participants (actual)

Study arms

  • Other
    MEPic

    * Ready for extubation (pass SBT) * Measurement of maximum expiratory pressure during the induced cough (MEPic)

    Diagnostic Test: MEPic

Interventions

  • Diagnostic testMEPic

    * 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

06

What researchers measure

Primary outcomes

  1. Extubation failure

    Endotracheal tube removal failure

    Time frame: 72 hours

  2. Extubation failure

    Endotracheal tube removal failure

    Time frame: 7 days

07

Study locations

1 site
  • Ladislao Diaz Ballve
    Haedo, Buenos Aires 1706, Argentina
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04356625
Lead sponsor
Hospital Nacional Profesor Alejandro Posadas
Responsible party
Sponsor
First posted
Apr 22, 2020
Start date
Oct 1, 2018
Primary completion
Sep 1, 2019
Completion
Sep 9, 2019
Last update
May 4, 2020

Study contacts

Ladislao P Diaz-Ballve, Lic.
principal investigator · Hospital Nacional Profesor Alejandro Posadas

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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