Respiratory Insufficiency Clinical Trial
— COUGH-ICUOfficial 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.
Verified date | January 2019 |
Source | Centre Hospitalier Régional d'Orléans |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | CHR d'Orléans | Orléans |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Régional d'Orléans |
France,
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
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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