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CompletedNCT02208479Updated Sep 23, 2015

Cardiac Surgery and Diaphragm Function

An observational study in Cardiac Surgery, sponsored by University Hospital, Grenoble. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-09-23.

Sponsored by University Hospital, Grenoble · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
66
Ages
18 Years and older
Sex
All
01

Study 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 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.

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Conditions studied

  • Cardiac Surgery

Keywords

  • cardiac surgery
  • diaphragm dysfunction
  • mechanical ventilation weaning
  • respiratory paralysis
  • muscle weakness
  • cardiac bypass
  • valvular surgery
  • respiratory insufficiency
03

In context

Lead sponsor

University Hospital, Grenoble is the lead sponsor of 815 studies on the registry; 205 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patient admitted in Intensive Care Unit (ICU) after planned cardiac surgery

Inclusion criteria

  • 18 years old and older
  • planned surgery
  • ready for weaning from mechanical ventilation

Exclusion criteria

Exclusion Criteria:

  • protected patient
  • patient refusal
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
66 participants (actual)
Patient registry
No

Groups and cohorts

  • cardiac surgery

    Other: Non invasive ultrasound measurement of the diaphragm thickness during breathing

Interventions

  • OtherNon invasive ultrasound measurement of the diaphragm thickness during breathing
06

What researchers measure

Primary outcomes

  1. Diaphragm inspiratory thickening fraction

    Time frame: At the begining of the spontaneous breathing trial (around 4hours after surgery)

Secondary outcomes

  1. Diaphragm dysfunction before surgery

    Time frame: the day before surgery

  2. Severity score (Euroscore)

    Time frame: the day before surgery

  3. extracorporeal circulation duration

    Time frame: peroperative

  4. left ventricular ejection fraction

    Time frame: the day before surgery

07

Study locations

1 site
  • Unité de Réanimation Cardio-vasculaire et Thoracique
    Grenoble, 38043, France
08

References and documents

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 24365607 ↗
  • McCool 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. Erratum In: N Engl J Med. 2012 May 31;366(22):2138. PubMed 22397655 ↗
  • Jaber 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 20813887 ↗
  • Moury 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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02208479
Lead sponsor
University Hospital, Grenoble
Responsible party
Sponsor
First posted
Aug 5, 2014
Start date
Jun 2014
Primary completion
Nov 2014
Completion
Nov 2014
Last update
Sep 23, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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