Pleuro-pulmonary Surgery Clinical Trial
— RECOfficial title:
Interest of Pleuropulmonary Echography Versus Standard Chest X-ray in the Post-operative Follow-up of Pleuropulmonary Surgery
| NCT number | NCT03835130 |
| Other study ID # | 18_RIPH3-06 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 25, 2019 |
| Est. completion date | July 23, 2019 |
| Verified date | July 2019 |
| Source | University Hospital Center of Martinique |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | July 23, 2019 |
| Est. primary completion date | February 25, 2019 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 18 Months and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Martinique | CHU Martinique | Fort de France |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital Center of Martinique |
Martinique,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of pleural disorders identified by each imaging technique | Number | between 2 and 10 days | |
| Secondary | Number of ultrasounds performed/number of chest x-ray performed | Ratio | one year | |
| Secondary | Proportion of "negative" ultrasounds | Number | one year |