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Completed

NCT Number: NCT03357198

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

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.

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Key information

Conditions

Respiratory Insufficiency Respiration Disorders Respiratory Tract Diseases Ventilator Weaning

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHR d'Orléans

Orléans, 45000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

    • Correlation between the two CPF assessment methods the days before extubation

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional d'Orléans

Other

Registry information

Official study 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.

Acronym: COUGH-ICU

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 29, 2017
Registry last updated
Jan 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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