Thoracic UltrasoundEchTHorNCT05545566
Evaluation of Thoracic Ultrasound in Monitoring Pleural Drainage in Postoperative Thoracic Surgery
A study testing Thoracic ultrasound versus chest X-ray in people with Thoracic Ultrasound and Pleural Drain Removal, run by University Hospital, Limoges at 1 site in France.
Trial summary
The investigator would like to conduct a study in patients undergoing thoracic surgery to evaluate the effectiveness of thoracic ultrasound in the decision to discharge the patient after pleural drain removal. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Ultrasound, Pleural Drain Removal
- What is being tested?
- Thoracic ultrasound versus chest X-ray
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 5 Sep 2022to 28 Feb 2023
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing thoracic surgery (lung resection, pleural symphysis, biopsy or resection of a mediastinal tumor or ganglion, pleural decortication/decalcification) admitted immediately after surgery in the thoracic surgery department (standard care or continuous care) of the University Hospital of Limoges.
Who cannot join
- Admission to the intensive care unit after thoracic surgery.
- Pneumonectomy
- Chest wall surgery
- Patients <18 years old
- Not affiliated to social security
- Under guardianship or curatorship
- Pregnant women
- Not knowing the French language
Trial locations and contacts
1 site in 1 country.
About this study
The investigator would like to conduct a study in patients undergoing thoracic surgery to evaluate the effectiveness of thoracic ultrasound in the decision to discharge the patient after pleural drain removal.
Read the detailed description
Thoracic drainage is a common and almost systematic practice after thoracic surgery requiring daily management and monitoring until and after its removal.
It allows, after opening the pleura, the evacuation of liquid and/or air retained in the pleural cavity.
The overall monitoring of the patient after thoracic surgery is based on clinical vigilance combined with thoracic imaging, in particular the chest X-ray which remains the Gold Standard (reference examination).
The removal of the drain is decided according to the quantity and appearance of the evacuated fluid, the persistence of air leaks, etc… A few hours after the removal of the drain, it is routine to perform a chest X-ray before authorizing a possible discharge from the department.
This practice does not correspond to an established scientific protocol but is systematically performed in our department before discharge.
Several studies have defended the place of ultrasound in thoracic imaging and its contribution to the detection of postoperative and intensive care complications.
Unlike radiography, this technique is non-irradiating, less expensive and more readily available. It allows the detection of pneumothorax, pleural effusions and other complications detectable on X-ray.
To our knowledge, the contribution of thoracic ultrasound has not been studied in the decision to authorize the discharge of the patient after removal of the thoracic drain.
- Conditions
- Thoracic Ultrasound, Pleural Drain Removal
- Being tested
- Thoracic ultrasound versus chest X-ray
- Keywords
- postoperative thoracic surgery, discharge decision, thoracic ultrasound, pleural drain removal, chest X-ray, thoracic surgery monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic ultrasound versus chest X-rayProcedure or surgery
Perform un ultrasound test, in addition to Chest X-Ray (usual practice), few hours after the surgery (D0), the next day (D1) and 4 to 6 hours after drain removal.
The data are collected in the standardized protocol for the two type of imaging.
The thoracic ultrasound and the Chest X-Ray are performed, blindly each other, in the same position for the patient and the same suction level of drain.
| Study group | Role | What they receive |
|---|---|---|
| All patients | Experimental | Not described Receives: Procedure: Thoracic ultrasound versus chest X-ray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Theoretical patient discharge
Theoretical patient discharge based on imaging data (pleural ultrasound or chest x-ray):
- YES: Score ≤ 2 on each of the 4 items assessed AND total score ≤ 4.
- NO: Score ≥ 3 on each of the items assessed and/or total score ≥ 5.
Measured: At the study completion, an average of 10 days
Secondary outcomes (5)
Pain du to examination
To compare the pain generated by each examination (thoracic radiography and pleural ultrasound) with Visual Analogic Scale (0 to 10) at Day 0, Day 1 and post-drainage)
Measured: Day 0, Day 1 and At the study completion, an average of 10 days
Subcutaneous emphysema
Evaluation of the concordance of pleural ultrasound data and chest radiography on the presence of subcutaneous emphysema at D0, D1 and post drain removal.
Measured: Day 0, Day 1 and At the study completion, an average of 10 days
Pneumothorax
Evaluation of the concordance of pleural ultrasound data and chest radiography on the presence of Pneumothorax at D0, D1 and post drain removal.
Measured: Day 0, Day 1 and At the study completion, an average of 10 days
Pleural effusion
Evaluation of the concordance of pleural ultrasound data and chest radiography on the presence of Pleural effusion at D0, D1 and post drain removal.
Measured: Day 0, Day 1 and At the study completion, an average of 10 days
Pulmonary Condensation
Evaluation of the concordance of pleural ultrasound data and chest radiography on the presence of Pulmonary Condensation at D0, D1 and post drain removal.
Measured: Day 0, Day 1 and At the study completion, an average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start5 Sep 2022
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thoracic UltrasoundStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05545566
- Sponsor's protocol ID
- 87RI22_0022 (EchTHor)
- Acronym
- EchTHor
- Status last verified
- Mar 2023
- First submitted
- 10 Sep 2022
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guesmi Z, Faure M, Ballouhey J, Atlagh L, Bertin F, Chermat A, Rivera C, Vincent F, Aguado B, Tricard J. Assessment of the interobserver reliability in discharge decision-making for patients undergoing thoracic surgery based on chest ultrasound compared to chest X-ray findings. Respir Med Res. 2026 May;89:101265. doi: 10.1016/j.resmer.2026.101265. Epub 2026 Mar 23.
PubMed 41974090
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Thoracic Ultrasound in Monitoring Pleural Drainage in Postoperative Thoracic Surgery
- ClinicalTrials.gov ID
- NCT05545566
- Acronym / sponsor ID
- EchTHor / 87RI22_0022 (EchTHor)
- Conditions
- Thoracic Ultrasound, Pleural Drain Removal
- Keywords
- postoperative thoracic surgery, discharge decision, thoracic ultrasound, pleural drain removal, chest X-ray, thoracic surgery monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 19 Sep 2022 (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.
The investigator would like to conduct a study in patients undergoing thoracic surgery to evaluate the effectiveness of thoracic ultrasound in the decision to discharge the patient after pleural drain removal.
Detailed description
Thoracic drainage is a common and almost systematic practice after thoracic surgery requiring daily management and monitoring until and after its removal.
It allows, after opening the pleura, the evacuation of liquid and/or air retained in the pleural cavity.
The overall monitoring of the patient after thoracic surgery is based on clinical vigilance combined with thoracic imaging, in particular the chest X-ray which remains the Gold Standard (reference examination).
The removal of the drain is decided according to the quantity and appearance of the evacuated fluid, the persistence of air leaks, etc… A few hours after the removal of the drain, it is routine to perform a chest X-ray before authorizing a possible discharge from the department.
This practice does not correspond to an established scientific protocol but is systematically performed in our department before discharge.
Several studies have defended the place of ultrasound in thoracic imaging and its contribution to the detection of postoperative and intensive care complications.
Unlike radiography, this technique is non-irradiating, less expensive and more readily available. It allows the detection of pneumothorax, pleural effusions and other complications detectable on X-ray.
To our knowledge, the contribution of thoracic ultrasound has not been studied in the decision to authorize the discharge of the patient after removal of the thoracic drain.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | Experimental | Procedure: Thoracic ultrasound versus chest X-ray |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing thoracic surgery (lung resection, pleural symphysis, biopsy or resection of a mediastinal tumor or ganglion, pleural decortication/decalcification) admitted immediately after surgery in the thoracic surgery department (standard care or continuous care) of the University Hospital of Limoges.
Key exclusion criteria (8 listed)
- Admission to the intensive care unit after thoracic surgery.
- Pneumonectomy
- Chest wall surgery
- Patients <18 years old
- Not affiliated to social security
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thoracic ultrasound versus chest X-rayPerform un ultrasound test, in addition to Chest X-Ray (usual practice), few hours after the surgery (D0), the next day (D1) and 4 to 6 hours after drain removal. The data are collected in the standardized protocol for the two type of imaging. The thoracic ultrasound and the Chest X-Ray are performed, blindly each other, in the same position for the patient and the same suction level of drain. | Procedure or surgery | All patients |
Primary outcome
Theoretical patient discharge
Time frame: At the study completion, an average of 10 days
Theoretical patient discharge based on imaging data (pleural ultrasound or chest x-ray): * YES: Score ≤ 2 on each of the 4 items assessed AND total score ≤ 4. * NO: Score ≥ 3 on each of the items assessed and/or total score ≥ 5.
5 secondary outcomes
Pain du to examination
Time frame: Day 0, Day 1 and At the study completion, an average of 10 days
Subcutaneous emphysema
Time frame: Day 0, Day 1 and At the study completion, an average of 10 days
Pneumothorax
Time frame: Day 0, Day 1 and At the study completion, an average of 10 days
Pleural effusion
Time frame: Day 0, Day 1 and At the study completion, an average of 10 days
Pulmonary Condensation
Time frame: Day 0, Day 1 and At the study completion, an average of 10 days
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 27 Oct 2026.
- Results publication: PubMed 41974090Guesmi Z, Faure M, Ballouhey J, Atlagh L, Bertin F, Chermat A, Rivera C, Vincent F, Aguado B, Tricard J. Assessment of the interobserver reliability in discharge decision-making for patients undergoing thoracic surgery based on chest ultrasound compared to chest X-ray findings. Respir Med Res. 2026 May;89:101265. doi: 10.1016/j.resmer.2026.101265. Epub 2026 Mar 23.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracic ultrasound versus chest X-ray in people with Thoracic Ultrasound and Pleural Drain Removal, run by University Hospital, Limoges at 1 site in France.
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 1 inclusion and 8 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 27 Oct 2026. 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 France. 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?
Theoretical patient discharge (time frame: At the study completion, an average of 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05545566, which also lists 1 linked publication.
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 27 Oct 2026.