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OpenTrials
Completed

NCT Number: NCT02208479

Cardiac Surgery and Diaphragm Function

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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Key information

Conditions

Cardiac Surgery Muscle Weakness Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Paralysis Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Insufficiency Respiratory Paralysis Respiratory Tract Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Unité de Réanimation Cardio-vasculaire et Thoracique

Grenoble, 38043, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • protected patient
  • patient refusal

Treatment and study plan

Non invasive ultrasound measurement of the diaphragm thickness during breathing

Other

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

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

Diaphragmatic Dysfunction in Cardiac Surgery: Observational Study

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Aug 5, 2014
Registry last updated
Sep 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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