COUGH-ICU: Correlation of Two Methods for Cough Peak Flow Measurement in Intubated Patients

Sponsor
Centre Hospitalier Régional d'Orléans (Other)
Overall Status
Completed
CT.gov ID
NCT03357198
Collaborator
(none)
62
1
8.7
7.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    62 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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.
    Actual Study Start Date :
    Dec 8, 2017
    Actual Primary Completion Date :
    Aug 29, 2018
    Actual Study Completion Date :
    Aug 29, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    cough peak flow measurement

    All enrolled patients will undergo measurement of cough peak flow by two methods, i.e. using a handheld electronic spirometer, and using the ventilator flowmeter, in a randomized order.

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. 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

    3. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHR d'Orléans Orléans France 45000

    Sponsors and Collaborators

    • Centre Hospitalier Régional d'Orléans

    Investigators

    • Principal Investigator: Guillaume FOSSAT, CHR Orléans

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Centre Hospitalier Régional d'Orléans
    ClinicalTrials.gov Identifier:
    NCT03357198
    Other Study ID Numbers:
    • CHRO-2017-02
    First Posted:
    Nov 29, 2017
    Last Update Posted:
    Jan 31, 2019
    Last Verified:
    Jan 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 31, 2019