Clinical trial NCT03357198: Correlation of Two Methods for Cough Peak Flow Measurement in Intubated Patients
Official title: Correlation of Cough Peak Flow Measurement by an Electronic Handheld Spirometer Connected to the Endotracheal Tube and by the Intensive Care Unit Ventilator Flowmeter.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Insufficiency
Ventilator Weaning
Lead sponsor: Centre Hospitalier Régional d'Orléans
Sponsor class: OTHER
First posted: 2017-11-29
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Correlation coefficient for the two CPF assessment methods, on extubation day
timeFrame: Within 1 hour before mechanical ventilation termination (extubation)
Secondary outcomes:
measure: Discriminatory power of CPF to predict successful weaning of mechanical ventilation, i.e. no reintubation within 72 hours after extubation, or unsuccessful weaning.
timeFrame: During the mechanical ventilation until 72 hours post extubation
measure: Assess the correlation between CPF and length of mechanical ventilation
timeFrame: During the mechanical ventilation until 72 hours post extubation
measure: 3. Correlation between the two CPF assessment methods the days before extubation
timeFrame: During the mechanical ventilation until 72 hours post extubation
Other outcomes:
Locations:
city: Orléans
country: France
facility: CHR d'Orléans
Study officials:
affiliation: CHR Orléans
name: Guillaume FOSSAT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Macintyre NR. Evidence-based assessments in the ventilator discontinuation process. Respir Care. 2012 Oct;57(10):1611-8. doi: 10.4187/respcare.02055.
citation: 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.