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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date November 24, 2017
First Posted Date November 29, 2017
Last Update Posted Date January 31, 2019
Actual Study Start Date December 8, 2017
Actual Primary Completion Date August 29, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 24, 2017)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 29, 2017)
  • 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
  • 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. 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
Original Secondary Outcome Measures
 (submitted: November 24, 2017)
  • Using CPF to predict weaning success [ Time Frame: During the mechanical ventilation until 72 hours post extubation ]
    Thresholds of CPF will be tested as predictors of weaning success
  • 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. 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Correlation of Two Methods for Cough Peak Flow Measurement in Intubated Patients
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.
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Respiratory Insufficiency
  • Ventilator Weaning
Intervention Not Provided
Study Groups/Cohorts 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 24, 2017)
62
Original Estimated Enrollment Same as current
Actual Study Completion Date August 29, 2018
Actual Primary Completion Date August 29, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03357198
Other Study ID Numbers CHRO-2017-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Centre Hospitalier Régional d'Orléans
Study Sponsor Centre Hospitalier Régional d'Orléans
Collaborators Not Provided
Investigators
Principal Investigator: Guillaume FOSSAT CHR Orléans
PRS Account Centre Hospitalier Régional d'Orléans
Verification Date January 2019