PneumothoraxChestDrainNCT06958848
16F vs 24F Chest Drain After Minimally Invasive Lobectomy and/or Segmentectomy
A study testing 16 F chest tube, 24 F chest tube and Early removal in people with Pneumothorax and Pleural Effusion, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The aim of the study is to evaluate postoperative pain in patients receiving a small-bore (16F) chest drain compared to those receiving the standard large-bore (24F) chest drain after minimally invasive pulmonary lobectomy and/or segmentectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumothorax, Pleural Effusion
- What is being tested?
- 16 F chest tube, 24 F chest tube and Early removal
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 May 2025to 30 Aug 2027
- Phase
- Interventional
- 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
Who may be able to join
- Informed Consent signed by the patient (all sex and gender)
- Patients' age from ≥ 18 to no age limit at time of study inclusion
- American Society of Anaesthesiologists (ASA) physical status classification I to IV
- Patients with resectable non-small cell lung cancer (NSCLC) deemed operable by minimally invasive surgical technique.
- Minimally invasive anatomical lung resections under general anaesthesia: lobectomy, lobectomy with wedge resection, lobectomy combined with segmentectomy, segmentectomy with wedge resection, bilobectomy
Who cannot join
- Previous thoracic surgery on the same side within 3 months
- Lung cancer complicated with pleural empyema
- Patients with chronic pain who receive opioids/gabapentin/pregabalin
- Patients who consume opiates/benzodiazepines
- Congestive heart failure NYHA Class III or IV
- Liver cirrhosis Child-Pugh Class B and C
Show all 15Show fewer
- Renal insufficiency requiring dialysis and/or estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2
- Patients with coagulopathy or bleeding disorders: von Willebrand disease, Hemophilia; Thrombocytopenia (<50 G/l), requiring platelet transfusion
- Patients with neuralgia
- Chest pain (site of surgery) without taking painkillers, measured by VAS while coughing > 10 mm
- Not consolidated rib fractures (in the last 3 months) on the side of surgical procedure
- Open anatomical lung resection, including pneumonectomy
- Insertion of 2 or more chest tubes
- Need for patient controlled intravenous anaesthesia or patient controlled epidural anaesthesia
- Patients intubated/sedated (not suitable due to difficulties to fill out the pain survey)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Basel
Basel, 4031
Helga Bachmann, MSc Clinical Research, +41 (0)61 328 71 70, helga.bachmann@usb.ch
Mallaev Makhmudbek, MD, +41 (0)61 556 51 89, makhmudbek.mallaev@usb.ch
About this study
Official title: Comparison of 16F Versus 24F Chest Drain After Minimally Invasive Pulmonary Lobectomy and/or Segmentectomy: a Monocentre Prospective Randomized Controlled Trial
The aim of the study is to evaluate postoperative pain in patients receiving a small-bore (16F) chest drain compared to those receiving the standard large-bore (24F) chest drain after minimally invasive pulmonary lobectomy and/or segmentectomy.
Read the detailed description
Lung cancer remains the leading cause of cancer-related death worldwide, and surgical resection remains the treatment of choice for patients with resectable non-small cell lung cancer (NSCLC), particularly in early stages of the disease. Anatomical lung resections such as lobectomy and segmentectomy are commonly performed, increasingly through minimally invasive techniques like video-assisted thoracoscopic surgery (VATS) and robotic-assisted thoracoscopic surgery (RATS). Compared to traditional thoracotomy, VATS and RATS has been associated with better postoperative outcomes, including less pain, shorter hospital stays, faster recovery, and improved quality of life.
After lung resections, the standard postoperative management involves the insertion of a chest drain to remove air and fluid from the pleural space and monitor for complications such as air leaks or bleeding. Traditionally, most thoracic surgery centres use a single large-bore chest tube, typically 24F in size, which remains in place at least until the first postoperative day. However, this practice is not based on strong evidence, and there is currently no consensus on the optimal size of the chest drain. In fact, removal of the chest tube has been shown to significantly improve ventilatory function and reduce pain, particularly in the early postoperative period.
The Chest Drain 16F vs 24F Study investigates whether the use of a smaller-bore chest drain (16F) leads to less postoperative pain compared to the standard large-bore 24F drain in patients undergoing minimally invasive pulmonary lobectomy and/or segmentectomy. In addition to comparing the tube sizes, the trial explores the safety and feasibility of early chest drain removal, defined as removal within 2 to 6 hours after surgery, provided that specific clinical criteria are met (e.g., minimal air leak and no signs of complications). While retrospective data and small prospective studies suggest that early removal and the use of smaller tubes may be beneficial, high-quality prospective data are lacking. This study aims to provide evidence to potentially change clinical practice by reducing patient discomfort without compromising safety.
- Conditions
- Pneumothorax, Pleural Effusion
- Being tested
- 16 F chest tube, 24 F chest tube, Early removal, Standard removal
- Keywords
- Lung Surgery, Chest Drainage, Minimally Invasive Thoracoscopic Lobectomy, Minimally Invasive Thoracoscopic Segmentectomy
- Medical subject headings
- Pneumothorax, Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
16 F chest tubeDevice
Also called Small-bore chest tube
Insertion of 16F chest tube
24 F chest tubeDevice
Also called Large-bore chest tube
Insertion of 24F chest tube
Early removalProcedure or surgery
Removal 2-6h after end of skin closure
Standard removalProcedure or surgery
Removal 1day postoperative
| Study group | Role | What they receive |
|---|---|---|
| 16F - early removal | Experimental | small-bore (16F) chest tubes, removal 2h until 6h after end of skin closure Receives: Device: 16 F chest tube; Procedure: Early removal |
| 16F - standard removal | Experimental | small-bore (16F) chest tubes, removal 1 day postoperative Receives: Device: 16 F chest tube; Procedure: Standard removal |
| 24F - early removal | Experimental | large-bore (24F) chest tubes, removal 2h until 6h after end of skin closure Receives: Device: 24 F chest tube; Procedure: Early removal |
| 24F - standard removal | Active comparator | large-bore (24F) chest tubes, removal 1 day postoperative Receives: Device: 24 F chest tube; Procedure: Standard removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative chest pain
Postoperative pain related to the placed chest drain (16F versus 24F), measured on a visual analogue scale (VAS) while coughing at different time points from skin closure until standard chest drain removal. The VAS is a horizontal line (100 mm) labelled from "no pain" on the left (0 mm) to "most extreme pain experienced" on the right (100 mm). Chest pain intensity is measured and recorded at rest and while coughing. For the current pain rating, the patient must be shown their last rating for comparison. The patient marks their information with a vertical line on the horizontal score line of the sheet paper. If needed, assistance with filling out the form will be provided. The evaluation is carried out by measuring the distance from the low anchor point to the marking; the recorded values are expressed in millimetres (0-100).
Measured: 4 and 6 hours after last suture; twice daily from day 1 to day 3 postoperative or until tube removal; on discharge home; on follow up day 30 and 180.
Postoperative acute pain relief while coughing
Postoperative acute pain relief while coughing in the other 5 pairwise comparisons.
Pain is measured on a visual analogue scale (VAS) while coughing. The VAS is a horizontal line (100 mm) labelled from "no pain" on the left (0 mm) to "most extreme pain experienced" on the right (100 mm).
Measured: 4 and 6 hours after last suture; twice daily from day 1 to day 3 postoperative or until tube removal; on discharge home; on follow up day 30 and 180.
Secondary outcomes (11)
Postoperative acute pain relief at rest
Postoperative acute pain relief at rest measured by an analgesia consumption adjusted pain intensity on a visual analogue scale at different time points in all subgroup comparisons. Pain is measured on a visual analogue scale (VAS) while coughing. The VAS is a horizontal line (100 mm) labelled from "no pain" on the left (0 mm) to "most extreme pain experienced" on the right (100 mm).
Measured: 4 and 6 hours after last suture; twice daily from day 1 to day 3 postoperative or until tube removal; on discharge home; on follow up day 30 and 180.
Analgesia consumption
Intraoperative and postoperative analgesia consumption at different time points.
Measured: 4 and 6 hours after last suture; twice daily from day 1 to day 3 postoperative or until tube removal; on discharge home; on follow up day 30 and 180.
Duration of the thoracic drainage
Duration of the thoracic drainage in hours from skin closure until chest tube removal if the air flow is ≤ 20 ml/min.
Measured: From 2 until 6 hours after last suture; twice daily from day 1 until the chest tube is removed.
Fluid output
Duration of fluid output reported per 24h measured in ml/kg/24h with Medela Thopaz+™ until the chest tube is removed.
Measured: From 2 until 6 hours after last suture; twice daily from day 1 until the chest tube is removed.
Length of hospital stay
Length of hospital stay in nights from the end of the operation to the time when the patient is fit for discharge.
Measured: Patients are discharged from hospital on the 3rd to 7th day, or stay up to the 10th day in case of prolonged air leak or re-operation.
Re-hospitalization
Re-hospitalization due to pleural complications.
Measured: After hospital discharge until 180-day follow up.
Postoperative morbidity
Postoperative morbidity related to the medical device and/or procedure. Respiratory, thoracic, mediastinal and cardiac adverse events (AE). Adverse events are recorded and described according to CTCAE 5.0.
Measured: During hospitalization and follow up until 30-day follow up.
Pleural complications
Pleural complications after early removal of chest tubes.The pleural complications will be graded according to Common Terminology Criteria for Adverse Events (CTCAE 5.0).
Measured: During hospitalization and follow up until 30-day follow up.
Mortality
In-hospital mortality; 30-day and 180-day mortality.
Measured: During hospitalization; 30 and 180 days after hospital discharge.
Chronic pain
Chronic pain intensity and pain quality assessment while coughing and at rest on 30/180-day after hospital discharge.
Measured: 30 and 180 days after hospital discharge.
Quality of life assessment
Quality of life measured by Short Form 12 (SF-12) questionnaire.
Measured: Preoperative and at 30/180-day follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start1 May 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumothoraxStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Didier Lardinois, MD, Study chair, University Hospital, Basel, SwitzerlandMakhmudbek Mallaev, MD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06958848
- Sponsor's protocol ID
- 2025-D0025; kt25Lardinois2
- Acronym
- ChestDrain
- Status last verified
- Apr 2026
- First submitted
- 17 Apr 2025
- Last updated
- 6 May 2026
- 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 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 16F Versus 24F Chest Drain After Minimally Invasive Pulmonary Lobectomy and/or Segmentectomy: a Monocentre Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06958848
- Acronym / sponsor ID
- ChestDrain / 2025-D0025; kt25Lardinois2
- Conditions
- Pneumothorax, Pleural Effusion
- Keywords
- Lung Surgery, Chest Drainage, Minimally Invasive Thoracoscopic Lobectomy, Minimally Invasive Thoracoscopic Segmentectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 6 May 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.
The aim of the study is to evaluate postoperative pain in patients receiving a small-bore (16F) chest drain compared to those receiving the standard large-bore (24F) chest drain after minimally invasive pulmonary lobectomy and/or segmentectomy.
Detailed description
Lung cancer remains the leading cause of cancer-related death worldwide, and surgical resection remains the treatment of choice for patients with resectable non-small cell lung cancer (NSCLC), particularly in early stages of the disease. Anatomical lung resections such as lobectomy and segmentectomy are commonly performed, increasingly through minimally invasive techniques like video-assisted thoracoscopic surgery (VATS) and robotic-assisted thoracoscopic surgery (RATS). Compared to traditional thoracotomy, VATS and RATS has been associated with better postoperative outcomes, including less pain, shorter hospital stays, faster recovery, and improved quality of life.
After lung resections, the standard postoperative management involves the insertion of a chest drain to remove air and fluid from the pleural space and monitor for complications such as air leaks or bleeding. Traditionally, most thoracic surgery centres use a single large-bore chest tube, typically 24F in size, which remains in place at least until the first postoperative day. However, this practice is not based on strong evidence, and there is currently no consensus on the optimal size of the chest drain. In fact, removal of the chest tube has been shown to significantly improve ventilatory function and reduce pain, particularly in the early postoperative period.
The Chest Drain 16F vs 24F Study investigates whether the use of a smaller-bore chest drain (16F) leads to less postoperative pain compared to the standard large-bore 24F drain in patients undergoing minimally invasive pulmonary lobectomy and/or segmentectomy. In addition to comparing the tube sizes, the trial explores the safety and feasibility of early chest drain removal, defined as removal within 2 to 6 hours after surgery, provided that specific clinical criteria are met (e.g., minimal air leak and no signs of complications). While retrospective data and small prospective studies suggest that early removal and the use of smaller tubes may be beneficial, high-quality prospective data are lacking. This study aims to provide evidence to potentially change clinical practice by reducing patient discomfort without compromising safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 16F - early removal | Experimental | Device: 16 F chest tube, Procedure: Early removalsmall-bore (16F) chest tubes, removal 2h until 6h after end of skin closure |
| 16F - standard removal | Experimental | Device: 16 F chest tube, Procedure: Standard removalsmall-bore (16F) chest tubes, removal 1 day postoperative |
| 24F - early removal | Experimental | Device: 24 F chest tube, Procedure: Early removallarge-bore (24F) chest tubes, removal 2h until 6h after end of skin closure |
| 24F - standard removal | Active comparator | Device: 24 F chest tube, Procedure: Standard removallarge-bore (24F) chest tubes, removal 1 day postoperative |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Informed Consent signed by the patient (all sex and gender)
- Patients' age from ≥ 18 to no age limit at time of study inclusion
- American Society of Anaesthesiologists (ASA) physical status classification I to IV
- Patients with resectable non-small cell lung cancer (NSCLC) deemed operable by minimally invasive surgical technique.
- Minimally invasive anatomical lung resections under general anaesthesia: lobectomy, lobectomy with wedge resection, lobectomy combined with segmentectomy, segmentectomy with wedge resection, bilobectomy
Key exclusion criteria (15 listed)
- Previous thoracic surgery on the same side within 3 months
- Lung cancer complicated with pleural empyema
- Patients with chronic pain who receive opioids/gabapentin/pregabalin
- Patients who consume opiates/benzodiazepines
- Congestive heart failure NYHA Class III or IV
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 |
|---|---|---|
| 16 F chest tubeAlso: Small-bore chest tubeInsertion of 16F chest tube | Device | 16F - early removal, 16F - standard removal |
| 24 F chest tubeAlso: Large-bore chest tubeInsertion of 24F chest tube | Device | 24F - early removal, 24F - standard removal |
| Early removalRemoval 2-6h after end of skin closure | Procedure or surgery | 16F - early removal, 24F - early removal |
| Standard removalRemoval 1day postoperative | Procedure or surgery | 16F - standard removal, 24F - standard removal |
Primary outcome
Postoperative chest pain
Time frame: 4 and 6 hours after last suture; twice daily from day 1 to day 3 postoperative or until tube removal; on discharge home; on follow up day 30 and 180.
Postoperative pain related to the placed chest drain (16F versus 24F), measured on a visual analogue scale (VAS) while coughing at different time points from skin closure until standard chest drain removal. The VAS is a horizontal line (100 mm) labelled from "no pain" on the left (0 mm) to "most extreme pain experienced" on the right (100 mm). Chest pain intensity is measured and recorded at rest and while coughing. For the current pain rating, the patient must be shown their last rating for comparison. The patient marks their information with a vertical line on the horizontal score line of the sheet paper. If needed, assistance with filling out the form will be provided. The evaluation is carried out by measuring the distance from the low anchor point to the marking; the recorded values are expressed in millimetres (0-100).
Postoperative acute pain relief while coughing
Time frame: 4 and 6 hours after last suture; twice daily from day 1 to day 3 postoperative or until tube removal; on discharge home; on follow up day 30 and 180.
Postoperative acute pain relief while coughing in the other 5 pairwise comparisons. Pain is measured on a visual analogue scale (VAS) while coughing. The VAS is a horizontal line (100 mm) labelled from "no pain" on the left (0 mm) to "most extreme pain experienced" on the right (100 mm).
11 secondary outcomes
Postoperative acute pain relief at rest
Time frame: 4 and 6 hours after last suture; twice daily from day 1 to day 3 postoperative or until tube removal; on discharge home; on follow up day 30 and 180.
Analgesia consumption
Time frame: 4 and 6 hours after last suture; twice daily from day 1 to day 3 postoperative or until tube removal; on discharge home; on follow up day 30 and 180.
Duration of the thoracic drainage
Time frame: From 2 until 6 hours after last suture; twice daily from day 1 until the chest tube is removed.
Fluid output
Time frame: From 2 until 6 hours after last suture; twice daily from day 1 until the chest tube is removed.
Length of hospital stay
Time frame: Patients are discharged from hospital on the 3rd to 7th day, or stay up to the 10th day in case of prolonged air leak or re-operation.
Re-hospitalization
Time frame: After hospital discharge until 180-day follow up.
Postoperative morbidity
Time frame: During hospitalization and follow up until 30-day follow up.
Pleural complications
Time frame: During hospitalization and follow up until 30-day follow up.
Mortality
Time frame: During hospitalization; 30 and 180 days after hospital discharge.
Chronic pain
Time frame: 30 and 180 days after hospital discharge.
Quality of life assessment
Time frame: Preoperative and at 30/180-day follow up.
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 6 May 2026.
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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.
Didier Lardinois, MD study chair
University Hospital, Basel, Switzerland
Makhmudbek Mallaev, MD principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 16 F chest tube, 24 F chest tube and Early removal in people with Pneumothorax and Pleural Effusion, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 5 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 6 May 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 Switzerland. 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 Helga Bachmann, MSc Clinical Research (+41 (0)61 328 71 70, helga.bachmann@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative chest pain (time frame: 4 and 6 hours after last suture; twice daily from day 1 to day 3 postoperative or until tube removal; on discharge home; on follow up day 30 and 180.). 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?
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 6 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.