Pleuro-pulmonary SurgeryRECNCT03835130
Pleuropulmonary Echography Versus Standard Chest X-ray in the Post-operative Follow-up of Pleuropulmonary Surgery
An observational study of Pleuro-pulmonary Surgery, run by University Hospital Center of Martinique at 1 site in Martinique.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 months and older
- Conditions the study is for
- Pleuro-pulmonary Surgery
- How many people
- 40 participants
- Where
- 1 siteMartinique
- Study dates
- 25 Jan 2019to 23 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months and older
- All sexes
- Child, Adult, Older adult
Study population: Patients undergoing pleuro-pulmonary surgery
Who may be able to join
- 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
Who cannot join
- Patient minor
- Woman who is pregnant and breast feeding
- Patient no giving his free and informed consent orally
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Pleuro-pulmonary Surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of pleural disorders identified by each imaging technique
Number
Measured: between 2 and 10 days
Secondary outcomes (2)
Number of ultrasounds performed/number of chest x-ray performed
Ratio
Measured: one year
Proportion of "negative" ultrasounds
Number
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start25 Jan 2019
- Primary completion25 Feb 2019
- Study completion23 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleuro-pulmonary SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Center of Martinique
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas VENISSAC, MD-PhD, Principal investigator, CHU de Martinique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03835130
- Sponsor's protocol ID
- 18_RIPH3-06
- Acronym
- REC
- Status last verified
- Jul 2019
- First submitted
- 30 Oct 2018
- Last updated
- 8 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Pleuropulmonary Echography Versus Standard Chest X-ray in the Post-operative Follow-up of Pleuropulmonary Surgery
- ClinicalTrials.gov ID
- NCT03835130
- Acronym / sponsor ID
- REC / 18_RIPH3-06
- Conditions
- Pleuro-pulmonary Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital Center of MartiniqueUniversity, hospital or other
- Study start
- 25 Jan 2019 (actual)
- Primary completion
- 25 Feb 2019 (actual)
- Study completion
- 23 Jul 2019 (actual)
- First posted
- 8 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 months and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing pleuro-pulmonary surgery
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Patient minor
- Woman who is pregnant and breast feeding
- Patient no giving his free and informed consent orally
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of pleural disorders identified by each imaging technique
Time frame: between 2 and 10 days
Number
2 secondary outcomes
Number of ultrasounds performed/number of chest x-ray performed
Time frame: one year
Proportion of "negative" ultrasounds
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2019.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas VENISSAC, MD-PhD principal investigator
CHU de Martinique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pleuro-pulmonary Surgery, run by University Hospital Center of Martinique at 1 site in Martinique.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Martinique. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of pleural disorders identified by each imaging technique (time frame: between 2 and 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2019.