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

Airway Extubation Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04356625
• Other study ID #: 209LUP0S0/18
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: September 9, 2019

Study information

• Verified date: April 2020
• Source: Hospital Nacional Profesor Alejandro Posadas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 9, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Airway Extubation
• Cough

Intervention

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

Locations

Country	Name	City	State
Argentina	Ladislao Diaz Ballve	Haedo	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Nacional Profesor Alejandro Posadas

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Extubation failure	Endotracheal tube removal failure	72 hours
Primary	Extubation failure	Endotracheal tube removal failure	7 days