Correlation of Two Methods for Cough Peak Flow Measurement in Intubated Patients

Respiratory Insufficiency Clinical Trial

— COUGH-ICU  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03357198
• Other study ID #: CHRO-2017-02
• Status: Completed
• Start date: December 8, 2017
• Est. completion date: August 29, 2018

Study information

• Verified date: January 2019
• Source: Centre Hospitalier Régional d'Orléans
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: August 29, 2018
• Est. primary completion date: August 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pulmonary Valve Insufficiency
• Respiratory Insufficiency
• Ventilator Weaning

Locations

Country	Name	City	State
France	CHR d'Orléans	Orléans

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional d'Orléans

Country where clinical trial is conducted

France, 

References & Publications (4)

Macintyre NR. Evidence-based assessments in the ventilator discontinuation process. Respir Care. 2012 Oct;57(10):1611-8. Review. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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