Comparison of Two Methods for Assessing Cough Capacity in Intensive Care Unit After Cardiac Surgery (DEPT)

January 21, 2020 updated by: Centre Chirurgical Marie Lannelongue

Comparison of Two Methods for Assessing Cough Capacity in Intensive Care Unit After Cardiac Surgery: Parietal Ultrasound vs. Peak Expiratory Cough Flow

Weaning from mechanical ventilation represents 50% of the time spent under mechanical ventilation (1). The risk factors identified in the failure to wean from mechanical ventilation are:

  • left heart dysfunction with LVEF < 30%.
  • an ineffective cough
  • presence of resuscitation neuromyopathy
  • mechanical ventilation time >7 days
  • presence of a delirium
  • age >65 years old
  • abundant bronchial secretion
  • presence of underlying lung pathology An ineffective cough is found in 40% of patients requiring reintubation. However, cough assessment is most often approximate, based on a subjective assessment of cough strength by asking the patient to cough spontaneously on his or her tube).

The objective evaluation of cough is based on the measurement of the peak expiratory flow rate at cough, commonly referred to as peak expiratory flow rate at cough (PEFD), the patient is asked to take a deep breath and then cough as hard as possible.

Subjective cough assessment does not predict the occurrence of ventilatory withdrawal failure. Conversely, all studies that objectively assessed the strength of cough before extubation by measuring the PEFD found a significant association with the outcome of extubation: a low PEFD increases the risk of extubation failure by a factor of 5 to 9.

The investigators hypothesize that the increase in parietal abdominal muscle contraction obtained by using a non-invasive ultrasound method indicates an effective cough. Conversely, an ineffective cough can be detected by this simple ultrasound criterion, which can be performed at the patient's bedside and extrapolated to all intensive care units equipped with an ultrasound scanner. This evaluation will be carried out before extubation: during the spontaneous ventilation test on a tube in a half-seated position (>45°) and within 24 hours after extubation.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

44

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Le Plessis-Robinson, France, 92350
        • Centre Chirurgical Marie Lannelongue

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient admitted to intensive care, intubated after cardiac surgery by sternotomy.

Description

Inclusion Criteria:

  • Major patients admitted for intubated resuscitation, ventilated after sternotomy cardiac surgery and having a mechanical ventilation time of less than 48 hours.

Exclusion Criteria:

  • Pregnant patient
  • Recent history of stroke(<6 months )
  • Minor patient
  • Neurological disorder (Alzheimer's disease, delirium, confusion)
  • Emphysemal patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
parietal ultrasound
Time Frame: 48 hours
compare parietal ultrasound with peak expiratory flow rate measurement (PEFD) in patients ventilated less than 48 hours after cardiac surgery with a sternal approach.
48 hours
peak expiratory flow rate
Time Frame: 48 hours
compare parietal ultrasound with peak expiratory flow rate measurement (PEFD) in patients ventilated less than 48 hours after cardiac surgery with a sternal approach.
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2018

Primary Completion (Actual)

July 9, 2019

Study Completion (Actual)

July 9, 2019

Study Registration Dates

First Submitted

June 6, 2019

First Submitted That Met QC Criteria

June 11, 2019

First Posted (Actual)

June 12, 2019

Study Record Updates

Last Update Posted (Actual)

January 23, 2020

Last Update Submitted That Met QC Criteria

January 21, 2020

Last Verified

May 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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