Pneumothorax Iatrogenic PostproceduralLUNG_US_SIMPNCT07854340
Clinical Value of Routine Chest Radiography and Point-of-Care Lung Ultrasound Following Ambulatory Thoracic Sympathectomy
An observational study of Pneumothorax Iatrogenic Postprocedural, run by Clinica Alemana de Santiago at 1 site in Chile.
Trial summary
The goal of this observational study is to find out whether routine chest X-rays after surgery actually change patient care, and whether lung ultrasound could be a suitable alternative for detecting important postoperative findings in adults undergoing same-day bilateral thoracic sympathectomy for primary… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumothorax Iatrogenic Postprocedural
- How many people
- 200 participants
- Where
- 1 siteChile
- Study dates
- 1 Oct 2026to 31 Oct 2027
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: The study population consists of adult patients aged 18 years or older who are scheduled to undergo outpatient bilateral thoracic sympathectomy for primary hyperhidrosis or facial flushing, with same-day discharge planned. The study is focused on patients treated in a single institution under routine clinical practice, where postoperative chest X-ray is part of the current standard of care. Only patients who provide written informed consent are included. This population is intended to represent ambulatory adults undergoing elective bilateral thoracic sympathectomy, while excluding patients with conditions that could interfere with standardized postoperative lung ultrasound assessment or alter the usual outpatient pathway, such as previous thoracic surgery, significant chest wall deformity, or intraoperative complications requiring hospitalization.
Who may be able to join
- Adults aged 18 years or older with a scheduled bilateral thoracic sympathectomy for primary hyperhidrosis or facial flushing.
- Same-day discharge surgery planned.
- Signed informed consent.
Who cannot join
- Previous ipsilateral or bilateral thoracic surgery.
- Chest wall deformity
- Post-inclusion elimination criteria
- Intraoperative conversion.
- Complication requiring hospitalization.
- Technically non-interpretable ultrasound examination in both hemithoraces.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chile1 site
Clínica Alemana Santiago
Santiago
Alonso Blanch, MD, +56934600652, blanchx4@gmail.com
About this study
Official title: Clinical Value of Routine Chest Radiography and Point-of-Care Lung Ultrasound Following Ambulatory Thoracic Sympathectomy"
The goal of this observational study is to find out whether routine chest X-rays after surgery actually change patient care, and whether lung ultrasound could be a suitable alternative for detecting important postoperative findings in adults undergoing same-day bilateral thoracic sympathectomy for primary hyperhidrosis or facial flushing. The main questions it aims to answer are:
How often does a routine postoperative chest X-ray change clinical management? Can lung ultrasound detect relevant postoperative findings as effectively as chest X-ray? Researchers will compare lung ultrasound results and the treatment decision that would have been made based on ultrasound alone with the actual treatment decision based on chest X-ray to see if using lung ultrasound first, with chest X-ray only when needed, could reduce radiation exposure and imaging costs without affecting care.
Read more
Participants will:
Have a routine chest X-ray after surgery. Have a lung ultrasound exam in the recovery unit before the chest X-ray result is known.
Have their postoperative care recorded based on the actual chest X-ray result. Be monitored for short-term outcomes after discharge.
Read the detailed description
Participants will:
Have a routine chest X-ray after surgery. Have a lung ultrasound exam in the recovery unit before the chest X-ray result is known.
Have their postoperative care recorded based on the actual chest X-ray result. Be monitored for short-term outcomes after discharge.
- Conditions
- Pneumothorax Iatrogenic Postprocedural
- Keywords
- thoracic surgery, PocUS, PNEUMOTHORAX, LUNG SLIDING
- Medical subject headings
- Pneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patient after sympathectomy | Participants will: Undergo a routine postoperative chest X-ray as part of the current standard of care. Receive an additional lung ultrasound examination performed by the treating anesthesiologist on arrival in the recovery unit, before the chest X-ray result is available. Have the anesthesiologist record the hypothetical clinical decision that would have been made based only on the ultrasound findings. Be followed for postoperative outcomes, including unplanned hospitalization, emergency consultation within 24 hours, and pleural intervention or readmission within 30 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung US
Features of Lung US examination; Presence the lung sliding in 2D mode and seashore sign in M-mode. The probe will be placed in 3 points of examination per side according blue protocol for lung US ( anterior area, mid anterior and postero lateral ).
Measured: In PACU area using Sonosite US with curve probe. During the first 30 minutes after extubation.
Chest X-RAY
Chest X-RAY report by radiologist with the presence of one of the following:
Visceral Pleural Line: A crisp, thin, hair-like white line contouring the edge of the lung parenchyma, separated from the inner thoracic wall.
Absence of Bronchovascular Markings: The peripheral space between the visceral pleural line and the chest wall (the pleural space) is hyperlucent (pure black) and completely devoid of pulmonary vessels and lung architecture.
Increased Volume / Shift of the Collapsed Lung: The underlying lung shrinks toward the hilum, becoming denser (more radiopaque) as alveolar air decreases.
Measured: In PACU during the first 30 minutes after extubation with portable X-ray equipment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pneumothorax Iatrogenic PostproceduralStudies 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
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Clinica Alemana de Santiago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javiera Vargas, Clinica Alemana de Santiago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07854340
- Sponsor's protocol ID
- Pendant
- Acronym
- LUNG_US_SIMP
- Status last verified
- Sep 2026
- First submitted
- 20 Aug 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly. Because of the risk of re-identification, even after de-identification, the dataset will not be made openly available.
Publications
Alrajhi K, Woo MY, Vaillancourt C. Test characteristics of ultrasonography for the detection of pneumothorax: a systematic review and meta-analysis. Chest. 2012 Mar;141(3):703-708. doi: 10.1378/chest.11-0131. Epub 2011 Aug 25.
PubMed 21868468Winberg C, Prager R, Kim CS, Meyer M, Arntfield R. Comparative evaluation of lung ultrasound versus chest X-ray for pneumothorax assessment post-invasive intrathoracic procedures: A case-costing evaluation. Medicine (Baltimore). 2025 Apr 25;104(17):e41959. doi: 10.1097/MD.0000000000041959.
PubMed 40295252Ranganath L, Gowda D, G N M. Diagnostic Accuracy of Point-of-Care Ultrasound in Detecting Pneumothorax: A Systematic Review and Meta-Analysis. Cureus. 2026 Jan 2;18(1):e100652. doi: 10.7759/cureus.100652. eCollection 2026 Jan.
PubMed 41635328Porter ED, Kelly JL, Fay KA, Hasson RM, Millington TM, Finley DJ, Phillips JD. Reducing Unnecessary Chest X-Ray Films After Thoracic Surgery: A Quality Improvement Initiative. Ann Thorac Surg. 2021 Mar;111(3):1012-1018. doi: 10.1016/j.athoracsur.2020.05.161. Epub 2020 Jul 30.
PubMed 32739255Galata C, Cascant Ortolano L, Shafiei S, Hetjens S, Muller L, Stauber RH, Stamenovic D, Roessner ED, Karampinis I. Are Routine Chest X-rays Necessary following Thoracic Surgery? A Systematic Literature Review and Meta-Analysis. Cancers (Basel). 2022 Sep 7;14(18):4361. doi: 10.3390/cancers14184361.
PubMed 36139521
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Value of Routine Chest Radiography and Point-of-Care Lung Ultrasound Following Ambulatory Thoracic Sympathectomy"
- ClinicalTrials.gov ID
- NCT07854340
- Acronym / sponsor ID
- LUNG_US_SIMP / Pendant
- Conditions
- Pneumothorax Iatrogenic Postprocedural
- Keywords
- thoracic surgery, PocUS, PNEUMOTHORAX, LUNG SLIDING
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Clinica Alemana de SantiagoUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 2 Oct 2026 (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 goal of this observational study is to find out whether routine chest X-rays after surgery actually change patient care, and whether lung ultrasound could be a suitable alternative for detecting important postoperative findings in adults undergoing same-day bilateral thoracic sympathectomy for primary hyperhidrosis or facial flushing. The main questions it aims to answer are:
How often does a routine postoperative chest X-ray change clinical management? Can lung ultrasound detect relevant postoperative findings as effectively as chest X-ray? Researchers will compare lung ultrasound results and the treatment decision that would have been made based on ultrasound alone with the actual treatment decision based on chest X-ray to see if using lung ultrasound first, with chest X-ray only when needed, could reduce radiation exposure and imaging costs without affecting care.
Participants will:
Have a routine chest X-ray after surgery. Have a lung ultrasound exam in the recovery unit before the chest X-ray result is known.
Have their postoperative care recorded based on the actual chest X-ray result. Be monitored for short-term outcomes after discharge.
Detailed description
Participants will:
Have a routine chest X-ray after surgery. Have a lung ultrasound exam in the recovery unit before the chest X-ray result is known.
Have their postoperative care recorded based on the actual chest X-ray result. Be monitored for short-term outcomes after discharge.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient after sympathectomy | – | –Participants will: Undergo a routine postoperative chest X-ray as part of the current standard of care. Receive an additional lung ultrasound examination performed by the treating anesthesiologist on arrival in the recovery unit, before the chest X-ray result is available. Have the anesthesiologist record the hypothetical clinical decision that would have been made based only on the ultrasound findings. Be followed for postoperative outcomes, including unplanned hospitalization, emergency consultation within 24 hours, and pleural intervention or readmission within 30 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients aged 18 years or older who are scheduled to undergo outpatient bilateral thoracic sympathectomy for primary hyperhidrosis or facial flushing, with same-day discharge planned. The study is focused on patients treated in a single institution under routine clinical practice, where postoperative chest X-ray is part of the current standard of care. Only patients who provide written informed consent are included. This population is intended to represent ambulatory adults undergoing elective bilateral thoracic sympathectomy, while excluding patients with conditions that could interfere with standardized postoperative lung ultrasound assessment or alter the usual outpatient pathway, such as previous thoracic surgery, significant chest wall deformity, or intraoperative complications requiring hospitalization.
Key inclusion criteria (3 listed)
- Adults aged 18 years or older with a scheduled bilateral thoracic sympathectomy for primary hyperhidrosis or facial flushing.
- Same-day discharge surgery planned.
- Signed informed consent.
Key exclusion criteria (6 listed)
- Previous ipsilateral or bilateral thoracic surgery.
- Chest wall deformity
- Post-inclusion elimination criteria
- Intraoperative conversion.
- Complication requiring hospitalization.
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
Lung US
Time frame: In PACU area using Sonosite US with curve probe. During the first 30 minutes after extubation.
Features of Lung US examination; Presence the lung sliding in 2D mode and seashore sign in M-mode. The probe will be placed in 3 points of examination per side according blue protocol for lung US ( anterior area, mid anterior and postero lateral ).
Chest X-RAY
Time frame: In PACU during the first 30 minutes after extubation with portable X-ray equipment.
Chest X-RAY report by radiologist with the presence of one of the following: Visceral Pleural Line: A crisp, thin, hair-like white line contouring the edge of the lung parenchyma, separated from the inner thoracic wall. Absence of Bronchovascular Markings: The peripheral space between the visceral pleural line and the chest wall (the pleural space) is hyperlucent (pure black) and completely devoid of pulmonary vessels and lung architecture. Increased Volume / Shift of the Collapsed Lung: The underlying lung shrinks toward the hilum, becoming denser (more radiopaque) as alveolar air decreases.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Background: PubMed 21868468Alrajhi K, Woo MY, Vaillancourt C. Test characteristics of ultrasonography for the detection of pneumothorax: a systematic review and meta-analysis. Chest. 2012 Mar;141(3):703-708. doi: 10.1378/chest.11-0131. Epub 2011 Aug 25.
- Background: PubMed 40295252Winberg C, Prager R, Kim CS, Meyer M, Arntfield R. Comparative evaluation of lung ultrasound versus chest X-ray for pneumothorax assessment post-invasive intrathoracic procedures: A case-costing evaluation. Medicine (Baltimore). 2025 Apr 25;104(17):e41959. doi: 10.1097/MD.0000000000041959.
- Background: PubMed 41635328Ranganath L, Gowda D, G N M. Diagnostic Accuracy of Point-of-Care Ultrasound in Detecting Pneumothorax: A Systematic Review and Meta-Analysis. Cureus. 2026 Jan 2;18(1):e100652. doi: 10.7759/cureus.100652. eCollection 2026 Jan.
- Background: PubMed 32739255Porter ED, Kelly JL, Fay KA, Hasson RM, Millington TM, Finley DJ, Phillips JD. Reducing Unnecessary Chest X-Ray Films After Thoracic Surgery: A Quality Improvement Initiative. Ann Thorac Surg. 2021 Mar;111(3):1012-1018. doi: 10.1016/j.athoracsur.2020.05.161. Epub 2020 Jul 30.
- Background: PubMed 36139521Galata C, Cascant Ortolano L, Shafiei S, Hetjens S, Muller L, Stauber RH, Stamenovic D, Roessner ED, Karampinis I. Are Routine Chest X-rays Necessary following Thoracic Surgery? A Systematic Literature Review and Meta-Analysis. Cancers (Basel). 2022 Sep 7;14(18):4361. doi: 10.3390/cancers14184361.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly. Because of the risk of re-identification, even after de-identification, the dataset will not be made openly available.
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.
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 Pneumothorax Iatrogenic Postprocedural, run by Clinica Alemana de Santiago at 1 site in Chile.
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 3 inclusion and 6 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: opening soon, as of the sponsor's last update on 2 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 Chile. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ALONSO BLANCH, MD (+56934600652, blanchx4@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung US (time frame: In PACU area using Sonosite US with curve probe. During the first 30 minutes after extubation.). The study lists 2 primary outcomes in all. 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 NCT07854340, which also lists 5 linked publications.
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 2 Oct 2026.