Intensive Care UnitDEPTNCT03983044
Comparison of Two Methods for Assessing Cough Capacity in Intensive Care Unit After Cardiac Surgery
An observational study of Intensive Care Unit and Cardiac Surgery, run by Centre Chirurgical Marie Lannelongue at 1 site in France.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Intensive Care Unit, Cardiac Surgery
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- 9 Oct 2018to 9 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient admitted to intensive care, intubated after cardiac surgery by sternotomy.
Who may be able to join
- Major patients admitted for intubated resuscitation, ventilated after sternotomy cardiac surgery and having a mechanical ventilation time of less than 48 hours.
Who cannot join
- Pregnant patient
- Recent history of stroke(<6 months )
- Minor patient
- Neurological disorder (Alzheimer's disease, delirium, confusion)
- Emphysemal patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read more
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.
- Conditions
- Intensive Care Unit, Cardiac Surgery
- Keywords
- cough evaluation, intensive care unit, utrasound evaluation
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2019
- Study start9 Oct 2018
- Primary completion9 Jul 2019
- Study completion9 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care UnitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Chirurgical Marie Lannelongue
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03983044
- Sponsor's protocol ID
- 2018-A01114-51
- Acronym
- DEPT
- Status last verified
- May 2019
- First submitted
- 6 Jun 2019
- Last updated
- 23 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Methods for Assessing Cough Capacity in Intensive Care Unit After Cardiac Surgery: Parietal Ultrasound vs. Peak Expiratory Cough Flow
- ClinicalTrials.gov ID
- NCT03983044
- Acronym / sponsor ID
- DEPT / 2018-A01114-51
- Conditions
- Intensive Care Unit, Cardiac Surgery
- Keywords
- cough evaluation, intensive care unit, utrasound evaluation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Centre Chirurgical Marie LannelongueUniversity, hospital or other
- Study start
- 9 Oct 2018 (actual)
- Primary completion
- 9 Jul 2019 (actual)
- Study completion
- 9 Jul 2019 (actual)
- First posted
- 12 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient admitted to intensive care, intubated after cardiac surgery by sternotomy.
Key inclusion criteria (1 listed)
- Major patients admitted for intubated resuscitation, ventilated after sternotomy cardiac surgery and having a mechanical ventilation time of less than 48 hours.
Key exclusion criteria (5 listed)
- Pregnant patient
- Recent history of stroke(<6 months )
- Minor patient
- Neurological disorder (Alzheimer's disease, delirium, confusion)
- Emphysemal patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care Unit and Cardiac Surgery, run by Centre Chirurgical Marie Lannelongue at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
parietal ultrasound (time frame: 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2020.