- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03983044
Comparison of Two Methods for Assessing Cough Capacity in Intensive Care Unit After Cardiac Surgery (DEPT)
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
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Le Plessis-Robinson, France, 92350
- Centre Chirurgical Marie Lannelongue
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
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compare parietal ultrasound with peak expiratory flow rate measurement (PEFD) in patients ventilated less than 48 hours after cardiac surgery with a sternal approach.
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48 hours
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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.
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48 hours
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-A01114-51
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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