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

NCT ID: NCT03357198

Last Updated: 2019-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

62 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-08

Study Completion Date

2018-08-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Respiratory Insufficiency Ventilator Weaning

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier Régional d'Orléans

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Guillaume FOSSAT

Role: PRINCIPAL_INVESTIGATOR

CHR Orléans

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHR d'Orléans

Orléans, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 12853532 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20097804 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 23013898 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23641924 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CHRO-2017-02

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.