Clinical trial NCT02208479: Cardiac Surgery and Diaphragm Function
Official title: Diaphragmatic Dysfunction in Cardiac Surgery: Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Surgery
Keywords: cardiac surgery
diaphragm dysfunction
mechanical ventilation weaning
respiratory paralysis
muscle weakness
cardiac bypass
valvular surgery
respiratory insufficiency
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2014-08-05
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient admitted in Intensive Care Unit (ICU) after planned cardiac surgery

Brief 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* protected patient
* patient refusal

Primary outcomes:
measure: Diaphragm inspiratory thickening fraction
timeFrame: At the begining of the spontaneous breathing trial (around 4hours after surgery)
Secondary outcomes:
measure: Diaphragm dysfunction before surgery
timeFrame: the day before surgery
measure: Severity score (Euroscore)
timeFrame: the day before surgery
measure: extracorporeal circulation duration
timeFrame: peroperative
measure: left ventricular ejection fraction
timeFrame: the day before surgery
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Unité de Réanimation Cardio-vasculaire et Thoracique
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.