## Protocol Section
### Identification Module
**NCT ID:** NCT02208479

**Brief Title:** Cardiac Surgery and Diaphragm Function

**Official Title:** Diaphragmatic Dysfunction in Cardiac Surgery: Observational Study

#### Organization Study ID Info
**ID:** 2014-13
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Grenoble
### Status Module
#### Completion Date
**Date:** 2014-11

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2015-09-23

**Type:** ESTIMATED

**Last Update Submit Date:** 2015-09-22

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2014-11

**Type:** ACTUAL

#### Start Date
**Date:** 2014-06

**Status Verified Date:** 2015-09

#### Study First Post Date
**Date:** 2014-08-05
**Type:** ESTIMATED
**Study First Submit Date:** 2014-08-01
**Study First Submit QC Date:** 2014-08-04
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University Hospital, Grenoble

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Cardiac Surgery

**Keywords:**

- cardiac surgery

- diaphragm dysfunction

- mechanical ventilation weaning

- respiratory paralysis

- muscle weakness

- cardiac bypass

- valvular surgery

- respiratory insufficiency

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 66

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

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

**Label:** cardiac surgery

### Interventions

#### Intervention 1

**Arm Group Labels:**

- cardiac surgery

**Name:** Non invasive ultrasound measurement of the diaphragm thickness during breathing

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Measure:** Diaphragm inspiratory thickening fraction

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

#### Secondary Outcomes

**Measure:** Diaphragm dysfunction before surgery

**Time Frame:** the day before surgery

**Measure:** Severity score (Euroscore)

**Time Frame:** the day before surgery

**Measure:** extracorporeal circulation duration

**Time Frame:** peroperative

**Measure:** left ventricular ejection fraction

**Time Frame:** the day before surgery

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

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

Exclusion Criteria:

* protected patient
* patient refusal

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** patient admitted in Intensive Care Unit (ICU) after planned cardiac surgery

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Grenoble

**Country:** France

**Facility:** Unité de Réanimation Cardio-vasculaire et Thoracique

**Zip:** 38043

### References Module

#### 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.

**PMID:** 24365607

**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. Erratum In: N Engl J Med. 2012 May 31;366(22):2138.

**PMID:** 22397655

**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.

**PMID:** 20813887

**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.

**PMID:** 31016412

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M14968

- Name: Respiratory Insufficiency

- Relevance: LOW

- As Found: Unknown

- ID: M20944

- Name: Muscle Weakness

- Relevance: LOW

- As Found: Unknown

- ID: M13204

- Name: Paresis

- Relevance: LOW

- As Found: Unknown

- ID: M4554

- Name: Asthenia

- Relevance: LOW

- As Found: Unknown

- ID: M13157

- Name: Paralysis

- Relevance: LOW

- As Found: Unknown

- ID: M14970

- Name: Respiratory Paralysis

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
