Iatrogenic InjuryPPcTNCT07148661
A Novel Technique to Remove Iatrogenic Pulmonary Parenchymal Chest Tube (PPcT): A Retrospective Analysis From a Tertiary Care Thoracic Surgery Centre
An observational study of Iatrogenic Injury and Iatrogenic Disease, run by University of Health Sciences Lahore at 1 site in Pakistan.
Trial summary
Iatrogenic Pulmonary Parenchymal chest Tube (PPcT) placement is a recognized but underreported complication of tube thoracostomy, described both in the subcontinent and worldwide. This complication occurs when the chest tube inadvertently traverses the pleural cavity and penetrates the lung parenchyma. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Iatrogenic Injury, Iatrogenic Disease
- What is being tested?
- Removal of PPcT
- Type of treatment
- Surgery or procedure
- How many people
- 163 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2024to 31 Jul 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients diagnosed with PPcT after chest tube thoracostomy either admitted to the thoracic surgery ward, emergency department, outpatient department and referred to Thoracic surgery department during the study period will be included.
Who may be able to join
- All Participants having PPcT diagnosed on radiological basis is included in this study.
Who cannot join
- Participnts having normally placed pleural chest tubes. Participants having chest tubes placed in fissures of the lung diagnosed on CT Scan of chest.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Services Institute of Medical Sciences(SIMS), Services Hospital.
Lahore, Punjab Province
About this study
Iatrogenic Pulmonary Parenchymal chest Tube (PPcT) placement is a recognized but underreported complication of tube thoracostomy, described both in the subcontinent and worldwide. This complication occurs when the chest tube inadvertently traverses the pleural cavity and penetrates the lung parenchyma. Patients with underlying lung pathology are at increased risk of having iatrogenic pulmonary parenchymal chest tube. In this study we describe the safe and minimally invasive technique to remove the PPcT without the need of video assisted thoracic surgery (VATS) or thoracotomy.
Read the detailed description
Patients with reduced pulmonary compliance, underlying lung consolidation, or dense pleural adhesions are particularly vulnerable because these conditions limit the normal displacement of the lung away from the chest wall, predisposing it to injury during tube placement.
Diagnosing PPcT is often challenging because the clinical presentation and radiographic findings are nonspecific, and the condition may be overlooked, particularly in patients with pre-existing pulmonary disease. Computed tomography (CT) of the chest remains the gold standard for accurate diagnosis.
At our institution, we have developed and successfully implemented a stepwise, minimally invasive technique for the safe removal of PPcT over the last 19 years (since 2006), thereby avoiding thoracotomy or other invasive procedures. Once PPcT is confirmed by CT scan-while carefully differentiating true parenchymal tube placement from tubes merely located within fissures-we adopt a three-stage removal strategy:
Initial healing phase: The tube is left in situ for approximately two weeks to allow for local fibrosis and healing around the injured parenchyma, which reduces the risk of bleeding and air leak during subsequent manipulation.
Gradual staged retraction: After this period, the tube is retracted by approximately 2 cm and secured again. In cases where the tube is tightly adherent, it is rotated 360° along its axis to release any fibrous adhesions. The patient is then observed for 24 hours, with close monitoring for hemodynamic instability, hemorrhage, or air leak, and a chest radiograph is obtained to confirm tube position.
Subsequent retractions: If the patient remains stable, they are discharged and readmitted at 7-day intervals for further staged retractions of approximately 2 cm each. This process continues until the fenestrations ("eyes") of the tube exit the pleural cavity, at which point the tube is safely removed. In many cases, the tube can be removed after the first or second stage if the fenestrations have already cleared the pleural space, thereby preventing pneumothorax.
This technique has consistently yielded excellent results in our experience, allowing safe removal of PPcT while minimizing morbidity and eliminating the need for thoracotomy or video-assisted thoracoscopic surgery (VATS) for tube retrieval.
- Conditions
- Iatrogenic Injury, Iatrogenic Disease
- Being tested
- Removal of PPcT
- Keywords
- Pulmonary Parenchymal chest Tube PPcT, Lung Parenchymal Injury, hemodynamic Instability, Removal of Chest Tube, Video Assisted Thoracoscopic Surgery (VATS), Thoracotomy
- Medical subject headings
- Iatrogenic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Removal of PPcTProcedure or surgery
Iatrogenic Pulmonary Parenchymal Chest Tube is removed as a staged procedure in which gradual retraction of 2cm of chest tube is done from lung parenchyma keeping an eye on the hemodynamic status of Patient.
| Study group | Role | What they receive |
|---|---|---|
| PPcT Group | Participants that have been diagnosed with Iatrogenic injury to lung in case of Pulmonary Parenchymal chest tube (PPcT) Receives: Procedure: Removal of PPcT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamic Instability
Hemodynamic Instability after staged removal of chest tube is defined as pulse rate of greater than 120/min, systolic Blood pressure of less than 80 mm of Hg, respiratory rate of greater than 24/min, hemorrhage and persistent air leak in the chest tube. Participants were observed for these above mentioned changes after every staged retraction of chest tube and responses recorded. For the participants who develop hemodynamic instability, thoracotomy was performed and underlying cause for hemodynamic instability is addressed.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start1 May 2024
- Primary completion30 Apr 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iatrogenic InjuryStudies of the same condition, open and under way.
- More trials run by University of Health Sciences LahoreThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Health Sciences Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeeshan Sarwar, University of Health Sciences Lahore
- Investigators
- Muhammad Shoaib Nabi, Clinical Professor, Principal investigator, Services Institute of Medical Sciences (SIMS), Services Hospital, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07148661
- Sponsor's protocol ID
- IRB/2025/1654/SIMS
- Acronym
- PPcT
- Status last verified
- Aug 2025
- First submitted
- 23 Aug 2025
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Technique to Remove Iatrogenic Pulmonary Parenchymal Chest Tube (PPcT): A Retrospective Analysis From a Tertiary Care Thoracic Surgery Centre
- ClinicalTrials.gov ID
- NCT07148661
- Acronym / sponsor ID
- PPcT / IRB/2025/1654/SIMS
- Conditions
- Iatrogenic Injury, Iatrogenic Disease
- Keywords
- Pulmonary Parenchymal chest Tube PPcT, Lung Parenchymal Injury, hemodynamic Instability, Removal of Chest Tube, Video Assisted Thoracoscopic Surgery (VATS), Thoracotomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- University of Health Sciences LahoreUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 29 Aug 2025 (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.
Iatrogenic Pulmonary Parenchymal chest Tube (PPcT) placement is a recognized but underreported complication of tube thoracostomy, described both in the subcontinent and worldwide. This complication occurs when the chest tube inadvertently traverses the pleural cavity and penetrates the lung parenchyma. Patients with underlying lung pathology are at increased risk of having iatrogenic pulmonary parenchymal chest tube. In this study we describe the safe and minimally invasive technique to remove the PPcT without the need of video assisted thoracic surgery (VATS) or thoracotomy.
Detailed description
Patients with reduced pulmonary compliance, underlying lung consolidation, or dense pleural adhesions are particularly vulnerable because these conditions limit the normal displacement of the lung away from the chest wall, predisposing it to injury during tube placement.
Diagnosing PPcT is often challenging because the clinical presentation and radiographic findings are nonspecific, and the condition may be overlooked, particularly in patients with pre-existing pulmonary disease. Computed tomography (CT) of the chest remains the gold standard for accurate diagnosis.
At our institution, we have developed and successfully implemented a stepwise, minimally invasive technique for the safe removal of PPcT over the last 19 years (since 2006), thereby avoiding thoracotomy or other invasive procedures. Once PPcT is confirmed by CT scan-while carefully differentiating true parenchymal tube placement from tubes merely located within fissures-we adopt a three-stage removal strategy:
Initial healing phase: The tube is left in situ for approximately two weeks to allow for local fibrosis and healing around the injured parenchyma, which reduces the risk of bleeding and air leak during subsequent manipulation.
Gradual staged retraction: After this period, the tube is retracted by approximately 2 cm and secured again. In cases where the tube is tightly adherent, it is rotated 360° along its axis to release any fibrous adhesions. The patient is then observed for 24 hours, with close monitoring for hemodynamic instability, hemorrhage, or air leak, and a chest radiograph is obtained to confirm tube position.
Subsequent retractions: If the patient remains stable, they are discharged and readmitted at 7-day intervals for further staged retractions of approximately 2 cm each. This process continues until the fenestrations ("eyes") of the tube exit the pleural cavity, at which point the tube is safely removed. In many cases, the tube can be removed after the first or second stage if the fenestrations have already cleared the pleural space, thereby preventing pneumothorax.
This technique has consistently yielded excellent results in our experience, allowing safe removal of PPcT while minimizing morbidity and eliminating the need for thoracotomy or video-assisted thoracoscopic surgery (VATS) for tube retrieval.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PPcT Group | – | Procedure: Removal of PPcTParticipants that have been diagnosed with Iatrogenic injury to lung in case of Pulmonary Parenchymal chest tube (PPcT) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients diagnosed with PPcT after chest tube thoracostomy either admitted to the thoracic surgery ward, emergency department, outpatient department and referred to Thoracic surgery department during the study period will be included.
Key inclusion criteria (1 listed)
- All Participants having PPcT diagnosed on radiological basis is included in this study.
Key exclusion criteria (1 listed)
- Participnts having normally placed pleural chest tubes. Participants having chest tubes placed in fissures of the lung diagnosed on CT Scan of chest.
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 |
|---|---|---|
| Removal of PPcTIatrogenic Pulmonary Parenchymal Chest Tube is removed as a staged procedure in which gradual retraction of 2cm of chest tube is done from lung parenchyma keeping an eye on the hemodynamic status of Patient. | Procedure or surgery | PPcT Group |
Primary outcome
Hemodynamic Instability
Time frame: 24 hours
Hemodynamic Instability after staged removal of chest tube is defined as pulse rate of greater than 120/min, systolic Blood pressure of less than 80 mm of Hg, respiratory rate of greater than 24/min, hemorrhage and persistent air leak in the chest tube. Participants were observed for these above mentioned changes after every staged retraction of chest tube and responses recorded. For the participants who develop hemodynamic instability, thoracotomy was performed and underlying cause for hemodynamic instability is addressed.
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 29 Aug 2025.
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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.
Muhammad Shoaib Nabi, Clinical Professor principal investigator
Services Institute of Medical Sciences (SIMS), Services Hospital, Lahore
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 Iatrogenic Injury and Iatrogenic Disease, run by University of Health Sciences Lahore at 1 site in Pakistan.
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 1 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 29 Aug 2025. 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 Pakistan. 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?
Hemodynamic Instability (time frame: 24 hours). 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 29 Aug 2025.