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

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ClinicalTrials.gov Identifier: NCT03357198
Recruitment Status : Completed
First Posted : November 29, 2017
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease
Respiratory Insufficiency Ventilator Weaning

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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 : December 8, 2017
Actual Primary Completion Date : August 29, 2018
Actual Study Completion Date : August 29, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough

Group/Cohort
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.



Primary Outcome Measures :
  1. Correlation coefficient for the two CPF assessment methods, on extubation day [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: During the mechanical ventilation until 72 hours post extubation ]
    3. Correlation between the two CPF assessment methods the days before extubation



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Critically ill patients undergoing invasive mechanical ventilation, sufficiently awake and cooperative to be assessed for their cough strength.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03357198


Locations
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France
CHR d'Orléans
Orléans, France, 45000
Sponsors and Collaborators
Centre Hospitalier Régional d'Orléans
Investigators
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Principal Investigator: Guillaume FOSSAT CHR Orléans

Publications:
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Responsible Party: Centre Hospitalier Régional d'Orléans
ClinicalTrials.gov Identifier: NCT03357198     History of Changes
Other Study ID Numbers: CHRO-2017-02
First Posted: November 29, 2017    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Insufficiency
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases