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

Completed

• Conditions: Respiratory Insufficiency; Ventilator Weaning

• Registration Number: NCT03357198
• Lead Sponsor: Centre Hospitalier Régional d'Orléans

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-24
• Study First Submitted QC: 2017-11-24
• Study First Posted: 2017-11-29
• Study Start: 2017-12-08
• Primary Completion: 2018-08-29
• Study Completion: 2018-08-29
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-30
• Last Update Posted: 2019-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation coefficient for the two CPF assessment methods, on extubation day	Within 1 hour before mechanical ventilation termination (extubation)	Correlation coefficient for the two CPF assessment methods, on extubation day

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHR d'Orléans; 🇫🇷 Orléans, France