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

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.

Study Overview

• Status: Completed
• Conditions: Airway Extubation
• Intervention / Treatment: Diagnostic test: MEPic

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires
    • Haedo, Buenos Aires, Argentina, 1706
      • Ladislao Diaz Ballve

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Diagnostic test: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extubation failure	Endotracheal tube removal failure	72 hours
Extubation failure	Endotracheal tube removal failure	7 days

Collaborators and Investigators

• Sponsor: Hospital Nacional Profesor Alejandro Posadas
• Investigators: Principal Investigator: Ladislao P Diaz-Ballve, Lic., Hospital Nacional Profesor Alejandro Posadas

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): September 9, 2019

Study Registration Dates

• First Submitted: April 20, 2020
• First Submitted That Met QC Criteria: April 20, 2020
• First Posted (Actual): April 22, 2020

Study Record Updates

• Last Update Posted (Actual): May 4, 2020
• Last Update Submitted That Met QC Criteria: April 30, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: ventilator weaning; airway extubation; maximal expiratory pressure; induced cough
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Cough
• Other Study ID Numbers: 209LUP0S0/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No