DD: Study of Diaphragm Mobility on Tissue Doppler

• Sponsor: Centre Hospitalier Universitaire Dijon (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03295344
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 25

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Surgery	Other: Diaphragm ultrasonography; Other: Tissue Doppler

Study Design

• Study Type: Observational
• Anticipated Enrollment: 300 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Study of Diaphragm Mobility on Tissue Doppler (Thoracotomy vs Sternotomy in Diaphragm Dysfunction Following Heart Surgery)
• Actual Study Start Date: Dec 1, 2016
• Anticipated Primary Completion Date: Dec 1, 2017
• Anticipated Study Completion Date: Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Patients	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
Healthy volunteers	Other: Tissue Doppler; Determine the threshold value for diaphragm mobility

Outcome Measures

Primary Outcome Measures

1. Measure diaphragm movement in TM (Time-Movement), in tissue Doppler [At baseline]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chu Dijon Bourogne	Dijon		France

Sponsors and Collaborators

• Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire Dijon
• ClinicalTrials.gov Identifier: NCT03295344
• Other Study ID Numbers: BOUARD ELLOUZE 2016
• First Posted: Sep 27, 2017
• Last Update Posted: Sep 27, 2017
• Last Verified: Sep 1, 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Sep 27, 2017