Maximum Expiratory Pressure in Induced Cough as a Predictor of Extubation Failure
Primary Purpose
Airway Extubation
Status
Completed
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
MEPic
Sponsored by
About this trial
This is an interventional diagnostic trial for Airway Extubation focused on measuring airway extubation, maximal expiratory pressure, induced cough, ventilator weaning
Eligibility Criteria
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.
Sites / Locations
- Ladislao Diaz Ballve
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
MEPic
Arm Description
Ready for extubation (pass SBT) Measurement of maximum expiratory pressure during the induced cough (MEPic)
Outcomes
Primary Outcome Measures
Extubation failure
Endotracheal tube removal failure
Extubation failure
Endotracheal tube removal failure
Secondary Outcome Measures
Full Information
NCT ID
NCT04356625
First Posted
April 20, 2020
Last Updated
April 30, 2020
Sponsor
Hospital Nacional Profesor Alejandro Posadas
1. Study Identification
Unique Protocol Identification Number
NCT04356625
Brief Title
Maximum Expiratory Pressure in Induced Cough as a Predictor of Extubation Failure
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.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
September 1, 2019 (Actual)
Study Completion Date
September 9, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Nacional Profesor Alejandro Posadas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Airway Extubation
Keywords
airway extubation, maximal expiratory pressure, induced cough, ventilator weaning
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single-arm clinical trial to establish diagnostic performance of MEPic
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MEPic
Arm Type
Other
Arm Description
Ready for extubation (pass SBT)
Measurement of maximum expiratory pressure during the induced cough (MEPic)
Intervention Type
Diagnostic Test
Intervention Name(s)
MEPic
Intervention Description
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
Primary Outcome Measure Information:
Title
Extubation failure
Description
Endotracheal tube removal failure
Time Frame
72 hours
Title
Extubation failure
Description
Endotracheal tube removal failure
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ladislao P Diaz-Ballve, Lic.
Organizational Affiliation
Hospital Nacional Profesor Alejandro Posadas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ladislao Diaz Ballve
City
Haedo
State/Province
Buenos Aires
ZIP/Postal Code
1706
Country
Argentina
12. IPD Sharing Statement
Plan to Share IPD
No
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Maximum Expiratory Pressure in Induced Cough as a Predictor of Extubation Failure
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