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:
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.
Condition or disease |
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Intensive Care Unit Cardiac Surgery |
Study Type : | Observational |
Actual Enrollment : | 44 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Official Title: | Comparison of Two Methods for Assessing Cough Capacity in Intensive Care Unit After Cardiac Surgery: Parietal Ultrasound vs. Peak Expiratory Cough Flow |
Actual Study Start Date : | October 9, 2018 |
Actual Primary Completion Date : | July 9, 2019 |
Actual Study Completion Date : | July 9, 2019 |
Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
France | |
Centre Chirurgical Marie Lannelongue | |
Le Plessis-Robinson, France, 92350 |
Tracking Information | |||||
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First Submitted Date | June 6, 2019 | ||||
First Posted Date | June 12, 2019 | ||||
Last Update Posted Date | January 23, 2020 | ||||
Actual Study Start Date | October 9, 2018 | ||||
Actual Primary Completion Date | July 9, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures | Not Provided | ||||
Original Secondary Outcome Measures | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Comparison of Two Methods for Assessing Cough Capacity in Intensive Care Unit After Cardiac Surgery | ||||
Official Title | Comparison of Two Methods for Assessing Cough Capacity in Intensive Care Unit After Cardiac Surgery: Parietal Ultrasound vs. Peak Expiratory Cough Flow | ||||
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:
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. |
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Detailed Description | Not Provided | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Case-Only Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | Patient admitted to intensive care, intubated after cardiac surgery by sternotomy. | ||||
Condition |
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Intervention | Not Provided | ||||
Study Groups/Cohorts | Not Provided | ||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Completed | ||||
Actual Enrollment |
44 | ||||
Original Estimated Enrollment | Same as current | ||||
Actual Study Completion Date | July 9, 2019 | ||||
Actual Primary Completion Date | July 9, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 100 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | France | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03983044 | ||||
Other Study ID Numbers | 2018-A01114-51 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Centre Chirurgical Marie Lannelongue | ||||
Study Sponsor | Centre Chirurgical Marie Lannelongue | ||||
Collaborators | Not Provided | ||||
Investigators | Not Provided | ||||
PRS Account | Centre Chirurgical Marie Lannelongue | ||||
Verification Date | May 2019 |