Cardiac SurgeryNCT02208479
Cardiac Surgery and Diaphragm Function
An observational study of Cardiac Surgery, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Diaphragm dysfunction is common after cardiac surgery and may delay weaning from mechanical ventilation and cause respiratory distress. The investigators' main objective is to determine the incidence of diaphragm dysfunction ( using the non-invasive ultrasonic method by calculating the inspiratory diaphragmatic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- Non invasive ultrasound measurement of the diaphragm thickness during breathing
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2014to Nov 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patient admitted in Intensive Care Unit (ICU) after planned cardiac surgery
Who may be able to join
- 18 years old and older
- planned surgery
- ready for weaning from mechanical ventilation
Who cannot join
- protected patient
- patient refusal
Trial locations and contacts
1 site in 1 country.
France1 site
Unité de Réanimation Cardio-vasculaire et Thoracique
Grenoble, 38043
About this study
Official title: Diaphragmatic Dysfunction in Cardiac Surgery: Observational Study
Diaphragm dysfunction is common after cardiac surgery and may delay weaning from mechanical ventilation and cause respiratory distress.
The investigators' main objective is to determine the incidence of diaphragm dysfunction ( using the non-invasive ultrasonic method by calculating the inspiratory diaphragmatic thickening fraction) in a selected population of cardiac surgery patients during weaning from mechanical ventilation.
The second endpoints are to determine the associated risk factors to post-operative diaphragm weakness and the consequence on the patient outcome.
- Conditions
- Cardiac Surgery
- Being tested
- Non invasive ultrasound measurement of the diaphragm thickness during breathing
- Keywords
- cardiac surgery, diaphragm dysfunction, mechanical ventilation weaning, respiratory paralysis, muscle weakness, cardiac bypass, valvular surgery, respiratory insufficiency
- Medical subject headings
- Respiratory Paralysis, Muscle Weakness, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non invasive ultrasound measurement of the diaphragm thickness during breathingOther
| Study group | Role | What they receive |
|---|---|---|
| cardiac surgery | Not described Receives: Other: Non invasive ultrasound measurement of the diaphragm thickness during breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragm inspiratory thickening fraction
Measured: At the begining of the spontaneous breathing trial (around 4hours after surgery)
Secondary outcomes (4)
Diaphragm dysfunction before surgery
Measured: the day before surgery
Severity score (Euroscore)
Measured: the day before surgery
extracorporeal circulation duration
Measured: peroperative
left ventricular ejection fraction
Measured: the day before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2014 (estimated)
- Study startJun 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiac SurgeryStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02208479
- Sponsor's protocol ID
- 2014-13
- Status last verified
- Sep 2015
- First submitted
- 1 Aug 2014
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
DiNino E, Gartman EJ, Sethi JM, McCool FD. Diaphragm ultrasound as a predictor of successful extubation from mechanical ventilation. Thorax. 2014 May;69(5):423-7. doi: 10.1136/thoraxjnl-2013-204111. Epub 2013 Dec 23.
PubMed 24365607McCool FD, Tzelepis GE. Dysfunction of the diaphragm. N Engl J Med. 2012 Mar 8;366(10):932-42. doi: 10.1056/NEJMra1007236. No abstract available.
PubMed 22397655Jaber S, Petrof BJ, Jung B, Chanques G, Berthet JP, Rabuel C, Bouyabrine H, Courouble P, Koechlin-Ramonatxo C, Sebbane M, Similowski T, Scheuermann V, Mebazaa A, Capdevila X, Mornet D, Mercier J, Lacampagne A, Philips A, Matecki S. Rapidly progressive diaphragmatic weakness and injury during mechanical ventilation in humans. Am J Respir Crit Care Med. 2011 Feb 1;183(3):364-71. doi: 10.1164/rccm.201004-0670OC. Epub 2010 Sep 2.
PubMed 20813887Moury PH, Cuisinier A, Durand M, Bosson JL, Chavanon O, Payen JF, Jaber S, Albaladejo P. Diaphragm thickening in cardiac surgery: a perioperative prospective ultrasound study. Ann Intensive Care. 2019 Apr 24;9(1):50. doi: 10.1186/s13613-019-0521-z.
PubMed 31016412
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diaphragmatic Dysfunction in Cardiac Surgery: Observational Study
- ClinicalTrials.gov ID
- NCT02208479
- Acronym / sponsor ID
- 2014-13
- Conditions
- Cardiac Surgery
- Keywords
- cardiac surgery, diaphragm dysfunction, mechanical ventilation weaning, respiratory paralysis, muscle weakness, cardiac bypass, valvular surgery, respiratory insufficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 5 Aug 2014 (estimated)
- 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.
Diaphragm dysfunction is common after cardiac surgery and may delay weaning from mechanical ventilation and cause respiratory distress.
The investigators' main objective is to determine the incidence of diaphragm dysfunction ( using the non-invasive ultrasonic method by calculating the inspiratory diaphragmatic thickening fraction) in a selected population of cardiac surgery patients during weaning from mechanical ventilation.
The second endpoints are to determine the associated risk factors to post-operative diaphragm weakness and the consequence on the patient outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cardiac surgery | – | Other: Non invasive ultrasound measurement of the diaphragm thickness during breathing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient admitted in Intensive Care Unit (ICU) after planned cardiac surgery
Key inclusion criteria (3 listed)
- 18 years old and older
- planned surgery
- ready for weaning from mechanical ventilation
Key exclusion criteria (2 listed)
- protected patient
- patient refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non invasive ultrasound measurement of the diaphragm thickness during breathing | Other | cardiac surgery |
Primary outcome
Diaphragm inspiratory thickening fraction
Time frame: At the begining of the spontaneous breathing trial (around 4hours after surgery)
4 secondary outcomes
Diaphragm dysfunction before surgery
Time frame: the day before surgery
Severity score (Euroscore)
Time frame: the day before surgery
extracorporeal circulation duration
Time frame: peroperative
left ventricular ejection fraction
Time frame: the day before surgery
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 Sep 2015.
- Background: PubMed 24365607DiNino E, Gartman EJ, Sethi JM, McCool FD. Diaphragm ultrasound as a predictor of successful extubation from mechanical ventilation. Thorax. 2014 May;69(5):423-7. doi: 10.1136/thoraxjnl-2013-204111. Epub 2013 Dec 23.
- Background: PubMed 22397655McCool FD, Tzelepis GE. Dysfunction of the diaphragm. N Engl J Med. 2012 Mar 8;366(10):932-42. doi: 10.1056/NEJMra1007236. No abstract available.
- Background: PubMed 20813887Jaber S, Petrof BJ, Jung B, Chanques G, Berthet JP, Rabuel C, Bouyabrine H, Courouble P, Koechlin-Ramonatxo C, Sebbane M, Similowski T, Scheuermann V, Mebazaa A, Capdevila X, Mornet D, Mercier J, Lacampagne A, Philips A, Matecki S. Rapidly progressive diaphragmatic weakness and injury during mechanical ventilation in humans. Am J Respir Crit Care Med. 2011 Feb 1;183(3):364-71. doi: 10.1164/rccm.201004-0670OC. Epub 2010 Sep 2.
- Derived from this study: PubMed 31016412Moury PH, Cuisinier A, Durand M, Bosson JL, Chavanon O, Payen JF, Jaber S, Albaladejo P. Diaphragm thickening in cardiac surgery: a perioperative prospective ultrasound study. Ann Intensive Care. 2019 Apr 24;9(1):50. doi: 10.1186/s13613-019-0521-z.
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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 Cardiac Surgery, run by University Hospital, Grenoble 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 3 inclusion and 2 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 Sep 2015. 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?
Diaphragm inspiratory thickening fraction (time frame: At the begining of the spontaneous breathing trial (around 4hours after surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02208479, which also lists 4 linked publications.
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 Sep 2015.