Pleuropulmonary Echography Versus Standard Chest X-ray in the Post-operative Follow-up of Pleuropulmonary Surgery (REC)

Interest of Pleuropulmonary Echography Versus Standard Chest X-ray in the Post-operative Follow-up of Pleuropulmonary Surgery

In postoperative pleuro-pulmonary surgery, the monitoring of the appearance of complications is guided, depending on the centres, by the systematic daily performance or, in the event of a call point, by chest x-ray at the patient's bed until the drains are ablative.

This repeated performance of radiographs results in irradiation of patients but also of medical staff and a significant cost.

In the thoracic study, ultrasound imaging is a fast, cost-effective, non-irradiating solution that can be performed at the patient's bedside. It could guide the performance of chest x-ray, limit their number, with increased clinical relevance.

Study Overview

• Status: Completed
• Conditions: Pleuro-pulmonary Surgery

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Martinique
  • Fort de France, Martinique, 97261
    • CHU Martinique

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing pleuro-pulmonary surgery

Description

Inclusion Criteria:

• Patient with a higher age to 18 and undergoing pleuro-pulmonary surgery
• Hospitalized patient at Martinique University Hospital
• Patient receiving social security
• Patient giving his free and informed consent orally

Exclusion Criteria:

• Patient minor
• Woman who is pregnant and breast feeding
• Patient no giving his free and informed consent orally

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of pleural disorders identified by each imaging technique	Number	between 2 and 10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of ultrasounds performed/number of chest x-ray performed	Ratio	one year
Proportion of "negative" ultrasounds	Number	one year

Collaborators and Investigators

• Sponsor: University Hospital Center of Martinique
• Investigators: Principal Investigator: Nicolas VENISSAC, MD-PhD, CHU de Martinique

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2019
• Primary Completion (Actual): February 25, 2019
• Study Completion (Actual): July 23, 2019

Study Registration Dates

• First Submitted: October 30, 2018
• First Submitted That Met QC Criteria: February 7, 2019
• First Posted (Actual): February 8, 2019

Study Record Updates

• Last Update Posted (Actual): August 8, 2019
• Last Update Submitted That Met QC Criteria: August 7, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 18_RIPH3-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No