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

NCT04356625 | Completed DMC

• 1 other identifier: 209LUP0S0/18
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Airway Extubation

Keywords

airway extubation; maximal expiratory pressure; induced cough; ventilator weaning

Outcome Measures

Primary Outcomes (2)

• Extubation failure

  Endotracheal tube removal failure

  72 hours

• Extubation failure

  Endotracheal tube removal failure

  7 days

Study Arms (1)

MEPic

OTHER

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

Diagnostic Test: MEPic

Interventions

MEPic DIAGNOSTIC_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

MEPic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Nacional Profesor Alejandro Posadas: lead

Study Sites (1)

Ladislao Diaz Ballve

Haedo, Buenos Aires, 1706, Argentina

Location

Related Publications (1)

• 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.

  PMID: 37712728 DERIVED

Study Officials

• Ladislao P Diaz-Ballve, Lic.

  Hospital Nacional Profesor Alejandro Posadas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-arm clinical trial to establish diagnostic performance of MEPic

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: April 22, 2020
• Study Start: October 1, 2018
• Primary Completion: September 1, 2019
• Study Completion: September 9, 2019
• Last Updated: May 4, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)