Cardiac Surgery and Diaphragm Function

Cardiac Surgery Clinical Trial

Official title:

Diaphragmatic Dysfunction in Cardiac Surgery: Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02208479
• Other study ID #: 2014-13
• Status: Completed
• Phase: N/A
• First received: August 1, 2014
• Last updated: September 22, 2015
• Start date: June 2014
• Est. completion date: November 2014

Study information

• Verified date: September 2015
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertésFrance: Ethics Committee
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years old and older

• planned surgery

• ready for weaning from mechanical ventilation

Exclusion Criteria:

• protected patient

• patient refusal

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiac Surgery

Intervention

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

Locations

Country	Name	City	State
France	Unité de Réanimation Cardio-vasculaire et Thoracique	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (3)

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. — View 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. — View Citation

McCool FD, Tzelepis GE. Dysfunction of the diaphragm. N Engl J Med. 2012 Mar 8;366(10):932-42. doi: 10.1056/NEJMra1007236. Review. Erratum in: N Engl J Med. 2012 May 31;366(22):2138. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diaphragm inspiratory thickening fraction		At the begining of the spontaneous breathing trial (around 4hours after surgery)	No
Secondary	Diaphragm dysfunction before surgery		the day before surgery	No
Secondary	Severity score (Euroscore)		the day before surgery	No
Secondary	extracorporeal circulation duration		peroperative	No
Secondary	left ventricular ejection fraction		the day before surgery	No