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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03357198
Other study ID # CHRO-2017-02
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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