Cardiac Surgery and Diaphragm Function

September 22, 2015 updated by: University Hospital, Grenoble

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

66

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • protected patient
  • patient refusal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
cardiac surgery
Other: Non invasive ultrasound measurement of the diaphragm thickness during breathing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Diaphragm inspiratory thickening fraction
Time Frame: At the begining of the spontaneous breathing trial (around 4hours after surgery)
At the begining of the spontaneous breathing trial (around 4hours after surgery)

Secondary Outcome Measures

Outcome Measure
Time Frame
Diaphragm dysfunction before surgery
Time Frame: the day before surgery
the day before surgery
Severity score (Euroscore)
Time Frame: the day before surgery
the day before surgery
extracorporeal circulation duration
Time Frame: peroperative
peroperative
left ventricular ejection fraction
Time Frame: the day before surgery
the day before surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

August 1, 2014

First Submitted That Met QC Criteria

August 4, 2014

First Posted (Estimate)

August 5, 2014

Study Record Updates

Last Update Posted (Estimate)

September 23, 2015

Last Update Submitted That Met QC Criteria

September 22, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2014-13

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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