Correlation of Two Methods for Cough Peak Flow Measurement in Intubated Patients (COUGH-ICU)

Correlation of Cough Peak Flow Measurement by an Electronic Handheld Spirometer Connected to the Endotracheal Tube and by the Intensive Care Unit Ventilator Flowmeter.

Cough Peak Flow (CPF) seems to be an efficient tool to assess cough capacity for the intensive care unit (ICU) ventilated patient. CPF can be used in the ventilator weaning process, as reflecting the upper airways protection capacity.

CPF requires disconnection of the patient from the ICU ventilator, supplemental material (handheld spirometer, antibacterial filter) and an excellent synchronization between the specialized caregiver and the patient.

We aimed that CPF with the ventilator built-in flow-meter is correlated with CPF using a handheld flowmeter connected to the endotracheal tube.

Study Overview

• Status: Completed
• Conditions: Respiratory Insufficiency; Ventilator Weaning

• Study Type: Observational
• Enrollment (Actual): 62

Contacts and Locations

Study Locations

• France
  • Orléans, France, 45000
    • CHR d'Orléans

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Critically ill patients undergoing invasive mechanical ventilation, sufficiently awake and cooperative to be assessed for their cough strength.

Description

Inclusion Criteria:

• Age > 18 years
• Mechanically ventilated patient > 24 hours
• Weaning ventilator phase (PEEP < 9 cmH2O and Support < 15 cm H2O)
• Richmond Agitation Sedation Scale between -1 and +1
• Patient's agreement to participate

Exclusion Criteria:

• Pregnant women
• Bronchospasm
• FiO2 > 70%
• Thoracic surgery < 7 days
• Abdominal surgery < 7 days
• Thoracic injury with rib fracture < 21 days
• Pneumothorax < 24 hours

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
cough peak flow measurement; All enrolled patients will undergo measurement of cough peak flow by two methods, i.e. using a handheld electronic spirometer, and using the ventilator flowmeter, in a randomized order.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation coefficient for the two CPF assessment methods, on extubation day	Correlation coefficient for the two CPF assessment methods, on extubation day	Within 1 hour before mechanical ventilation termination (extubation)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Discriminatory power of CPF to predict successful weaning of mechanical ventilation, i.e. no reintubation within 72 hours after extubation, or unsuccessful weaning.	Thresholds of CPF will be tested as predictors of weaning success	During the mechanical ventilation until 72 hours post extubation
Assess the correlation between CPF and length of mechanical ventilation	Assess the correlation between CPF and length of mechanical ventilation	During the mechanical ventilation until 72 hours post extubation
3. Correlation between the two CPF assessment methods the days before extubation	3. Correlation between the two CPF assessment methods the days before extubation	During the mechanical ventilation until 72 hours post extubation

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional d'Orléans

Publications and helpful links

General Publications

• Thille AW, Richard JC, Brochard L. The decision to extubate in the intensive care unit. Am J Respir Crit Care Med. 2013 Jun 15;187(12):1294-302. doi: 10.1164/rccm.201208-1523CI.
• Smina M, Salam A, Khamiees M, Gada P, Amoateng-Adjepong Y, Manthous CA. Cough peak flows and extubation outcomes. Chest. 2003 Jul;124(1):262-8. doi: 10.1378/chest.124.1.262.
• Su WL, Chen YH, Chen CW, Yang SH, Su CL, Perng WC, Wu CP, Chen JH. Involuntary cough strength and extubation outcomes for patients in an ICU. Chest. 2010 Apr;137(4):777-82. doi: 10.1378/chest.07-2808. Epub 2010 Jan 22.
• Macintyre NR. Evidence-based assessments in the ventilator discontinuation process. Respir Care. 2012 Oct;57(10):1611-8. doi: 10.4187/respcare.02055.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 8, 2017
• Primary Completion (ACTUAL): August 29, 2018
• Study Completion (ACTUAL): August 29, 2018

Study Registration Dates

• First Submitted: November 24, 2017
• First Submitted That Met QC Criteria: November 24, 2017
• First Posted (ACTUAL): November 29, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 31, 2019
• Last Update Submitted That Met QC Criteria: January 30, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: CHRO-2017-02

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