Study of Diaphragm Mobility on Tissue Doppler

NCT03295344 | Completed

• 1 other identifier: BOUARD ELLOUZE 2016
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

Diaphragm dysfunction is found in 10 to 90% of patients following heart surgery. In current practice diaphragm dysfunction is evaluated by 2D ultrasonography. Tissue Doppler is a validated technique to study heart contractility. Its use in the analysis of diaphragm function must be evaluated to determine its interest as a diagnostic tool. Better understanding of diaphragm dysfunction following heart surgery will lead to earlier management of post-operative respiratory complications and the implementation of preventive pre-operative measures. We intend to look for correlations between the TM (Time-Movement) mode and tissue Doppler in the assessment of diaphragm mobility.

Conditions

Heart Surgery

Outcome Measures

Primary Outcomes (1)

• Measure diaphragm movement in TM (Time-Movement), in tissue Doppler

  At baseline

Study Arms (2)

Patients

Other: Diaphragm ultrasonography

Healthy volunteers

Other: Tissue Doppler

Interventions

Diaphragm ultrasonography OTHER

Spontaneously breathing patients in the ½ seated position Heart transducer at the medio axillary position, parallel to the axis of the body, last intervertebral spaces US mode: 2D = Evaluation of the pulmonary parenchyma Time-Movement (TM) = Evaluation of diaphragm muscle shortening in the apposition zone + Evaluation of diaphragm mobility in the posterior 1/3 of the diaphragm dome Tissue Doppler Imaging (TDI) = Evaluation of diaphragm mobility in the diaphragm dome Collection of different daily clinical data

Patients

Tissue Doppler OTHER

Determine the threshold value for diaphragm mobility

Healthy volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients in the post-operative period following heart surgery

You may qualify if:

• Post-operative period following heart surgery

You may not qualify if:

• Patients younger than 18 years old
• Existence of a neuro-muscular disease
• Widened surgical approach
• Refusal of the patient
• Impossibility to see diaphragm movement

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourogne

Dijon, France

Location

Study Design

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

Study Record Dates

• First Submitted: September 25, 2017
• First Posted: September 27, 2017
• Study Start: May 2, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: February 28, 2023

Record last verified: 2023-02

Locations

FR (1)