NCT03357198

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 29, 2017

Completed
9 days until next milestone

Study Start

First participant enrolled

December 8, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2018

Completed
Last Updated

January 31, 2019

Status Verified

January 1, 2019

Enrollment Period

9 months

First QC Date

November 24, 2017

Last Update Submit

January 30, 2019

Conditions

Respiratory InsufficiencyVentilator Weaning

Outcome Measures

Primary Outcomes (1)

  • Correlation coefficient for the two CPF assessment methods, on extubation day

    Correlation coefficient for the two CPF assessment methods, on extubation day

    Within 1 hour before mechanical ventilation termination (extubation)

Secondary Outcomes (3)

  • 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

  • Assess the correlation between CPF and length of mechanical ventilation

    During the mechanical ventilation until 72 hours post extubation

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

    During the mechanical ventilation until 72 hours post extubation

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Critically ill patients undergoing invasive mechanical ventilation, sufficiently awake and cooperative to be assessed for their cough strength.

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant women
  • Bronchospasm
  • FiO2 \> 70%
  • Thoracic surgery \< 7 days
  • Abdominal surgery \< 7 days
  • Thoracic injury with rib fracture \< 21 days
  • Pneumothorax \< 24 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHR d'Orléans

Orléans, 45000, France

Location

Related Publications (4)

  • Smina M, Salam A, Khamiees M, Gada P, Amoateng-Adjepong Y, Manthous CA. Cough peak flows and extubation outcomes. Chest. 2003 Jul;124(1):262-8. doi: 10.1378/chest.124.1.262.

    PMID: 12853532BACKGROUND

  • Su WL, Chen YH, Chen CW, Yang SH, Su CL, Perng WC, Wu CP, Chen JH. Involuntary cough strength and extubation outcomes for patients in an ICU. Chest. 2010 Apr;137(4):777-82. doi: 10.1378/chest.07-2808. Epub 2010 Jan 22.

    PMID: 20097804BACKGROUND

  • Macintyre NR. Evidence-based assessments in the ventilator discontinuation process. Respir Care. 2012 Oct;57(10):1611-8. doi: 10.4187/respcare.02055.

    PMID: 23013898BACKGROUND

  • Thille AW, Richard JC, Brochard L. The decision to extubate in the intensive care unit. Am J Respir Crit Care Med. 2013 Jun 15;187(12):1294-302. doi: 10.1164/rccm.201208-1523CI.

    PMID: 23641924BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Guillaume FOSSAT

    CHR Orléans

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2017

First Posted

November 29, 2017

Study Start

December 8, 2017

Primary Completion

August 29, 2018

Study Completion

August 29, 2018

Last Updated

January 31, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)