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NCT03295344 Clinical Trial

Study of Diaphragm Mobility on Tissue Doppler

Heart Surgery Clinical Trial

— DD  

Official title:
Study of Diaphragm Mobility on Tissue Doppler (Thoracotomy vs Sternotomy in Diaphragm Dysfunction Following Heart Surgery)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03295344
Other study ID # BOUARD ELLOUZE 2016
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2, 2017
Est. completion date December 31, 2019

Study information
Verified date February 2023
Source Centre Hospitalier Universitaire Dijon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 170
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Post-operative period following heart surgery Exclusion Criteria: - Patients younger than 18 years old - Existence of a neuro-muscular disease - Widened surgical approach - Refusal of the patient - Impossibility to see diaphragm movement

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Diaphragm ultrasonography
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
• Tissue Doppler
Determine the threshold value for diaphragm mobility

Locations
Country Name City State
France Chu Dijon Bourogne Dijon

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Measure diaphragm movement in TM (Time-Movement), in tissue Doppler At baseline
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