Cough Peak Flow for Extubation Prediction

Extubation in ICU Patients Clinical Trial

— CPF  

Official title:

Assessing Cough Peak Flow (CPF) Using Ventilator built-in Flow-meter to Predict Extubation Success: A Single Centre Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02847221
• Other study ID #: 69HCL16_0495
• Status: Completed
• Phase: N/A
• First received: July 25, 2016
• Last updated: July 25, 2016
• Start date: November 2014
• Est. completion date: November 2015

Study information

• Verified date: July 2016
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial Summary

Successful weaning from mechanical ventilation in ICU patients depends on patient ability to breathe spontaneously and on cough efficiency. Previous studies found that cough peak flow (CPF) at 60 L/min threshold predicted extubation failure. These studies measured CPF using a dedicated flow-meter that required patient disconnection from the ventilator, limiting the generalizability of this procedure. This study aimed to predict extubation outcome in a consecutive series of patients by measuring CPF from the ventilator flow-meter. CPF measurements were done by freezing ventilator screen and scrolling the cursor to the maximal value of CPF during expiration and Tidal Volume (TV) in preceding inspiration.

The objective was to assess the performance of CPF to predict early extubation outcome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: November 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years

• Intubation > 24h

• Eligible for scheduled weaning trial and then scheduled extubation

• Mechanical ventilation from Evita XL ventilator (Dräger, Germany)

• Patient's agreement to participate

Exclusion Criteria:

• Withdrawal decision of life supporting care

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Extubation in ICU Patients

Locations

Country	Name	City	State
France	Medical Intensive care unit, Croix-Rousse Hospital. 103 Grande Rue de la Croix-Rousse	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early extubation success rate (EES rate)	Defining a relation between the CPF/TV ratio before extubation and early extubation success rate	48 hours	No
Secondary	Scheduled weaning trial success rate	Defining a relation between the CPF/TV ratio before weaning trial and scheduled weaning trial success rate	48 hours	No