Clinical trial NCT04356625: 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
Overall status: COMPLETED
Phase: NA
Conditions: Airway Extubation
Keywords: airway extubation
maximal expiratory pressure
induced cough
ventilator weaning
Lead sponsor: Hospital Nacional Profesor Alejandro Posadas
Sponsor class: OTHER
First posted: 2020-04-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-arm clinical trial to establish diagnostic performance of MEPic
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Extubation failure
timeFrame: 72 hours
measure: Extubation failure
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Haedo
country: Argentina
facility: Ladislao Diaz Ballve
state: Buenos Aires
Study officials:
affiliation: Hospital Nacional Profesor Alejandro Posadas
name: Ladislao P Diaz-Ballve, Lic.
role: PRINCIPAL_INVESTIGATOR
References: