Evolution of Diaphragm Thickness Under Veno-arterial ECMO

NCT04052230 | Completed

• 2 other identifiers: 38RC19.1422019-A01273-54
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective is to evaluate the evolution of the thickness of the diaphragm (during the first week of treatment) by VA ECMO in the resuscitation patients. The comprehension of the mechanisms involved in the diaphragm ailment will identify modifiable factors that lead to muscle degradation and thus to the deterioration of patients' prognosis.

Conditions

Diaphragm; Extracorporeal Membrane Oxygenation Complication

Keywords

diaphragm; ECMO; ICU

Outcome Measures

Primary Outcomes (1)

• To evaluate the evolution of the trophicity of the diaphragm muscle during the first week of treatment with VA ECMO in patients in intensive care.

  Evaluation of the trophicity of the diaphragm muscle at the end of the expiration from the first day in the intensive care unit after the ECMO implementation until the D7 of the hospitalization with ultrasound. A change greater than 10% of the thickness will define three groups of patients (loss of thickness, stability and thickness gain). The first day that this value is reached will determine the allocation in one or the other group.

  Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7

Secondary Outcomes (27)

• To evaluate the evolution of the performance of the diaphragm muscle in patients in intensive care.

  Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7

• To evaluate the link between the evolution of respiratory physiological variables and the diaphragm evolution in patients in intensive care.

  Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7

• To evaluate the link between the evolution of respiratory physiological variables and the diaphragm evolution in patients in intensive care.

  Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7

• To evaluate the link between the evolution of respiratory physiological variables and the diaphragm evolution in patients in intensive care.

  Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7

• To evaluate the link between the evolution of respiratory physiological variables and the diaphragm evolution in patients in intensive care.

  Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, and Day 7

Interventions

ultrasound measure OTHER

Admission to the intensive care unit, and setting up an ECMO Daily monitoring from D1 to D7, follow up at D60

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population is adult patients hospitalized in intensive care for circulatory insufficiency requiring assistance with ECMO VA.

You may qualify if:

• Patient hospitalized in intensive care
• Patient under veno-arterial ECMO
• Non-opposition of the patient or relatives
• Affiliation to a health insurance

You may not qualify if:

• Subject under guardianship or subject deprived of liberty
• Pregnant or lactating woman

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

CHU Grenoble Alpes

Grenoble, 38000, France

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2019
• First Posted: August 9, 2019
• Study Start: October 13, 2019
• Primary Completion: February 18, 2022
• Study Completion: April 19, 2022
• Last Updated: May 12, 2023

Record last verified: 2023-05

Locations

FR (1)