Comparison of Two Methods for Assessing Cough Capacity in Intensive Care Unit After Cardiac Surgery
DEPT
1 other identifier
observational
44
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 9, 2018
CompletedFirst Submitted
Initial submission to the registry
June 6, 2019
CompletedFirst Posted
Study publicly available on registry
June 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 9, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 9, 2019
CompletedJanuary 23, 2020
May 1, 2019
9 months
June 6, 2019
January 21, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
parietal ultrasound
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
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
Eligibility Criteria
Patient admitted to intensive care, intubated after cardiac surgery by sternotomy.
You may qualify if:
- Major patients admitted for intubated resuscitation, ventilated after sternotomy cardiac surgery and having a mechanical ventilation time of less than 48 hours.
You may not qualify if:
- Pregnant patient
- Recent history of stroke(\<6 months )
- Minor patient
- Neurological disorder (Alzheimer's disease, delirium, confusion)
- Emphysemal patient
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Chirurgical Marie Lannelongue
Le Plessis-Robinson, 92350, France
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2019
First Posted
June 12, 2019
Study Start
October 9, 2018
Primary Completion
July 9, 2019
Study Completion
July 9, 2019
Last Updated
January 23, 2020
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share