Early Chest Tube Removal for Lung Surgery

(PROTECTR Trial)

Overseen By Deb Lewis

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Lawson Health Research Institute

Disqualifiers: Low FEV1, Pleurodesis, Cognitive disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

130 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and feasibility of removing a chest tube just three hours after lung surgery performed with small incisions and a camera (VATS). The research compares this early removal approach to the usual practice of keeping the chest tube in longer, aiming to make recovery easier and faster for patients. Suitable participants have planned lung surgery through VATS for removing part of their lung and do not have severe lung function issues. As an unphased trial, this study offers patients the opportunity to contribute to innovative recovery methods that could enhance post-surgical care.

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this protocol is safe for early chest tube removal?

Studies have shown that removing the chest tube soon after lung surgery is safe for many patients. Research indicates that removing the chest tube within hours of surgery does not cause harm, even with some fluid drainage. One study found it safe for patients undergoing video-assisted thoracoscopic surgery (VATS). Another study confirmed that early removal after lung tissue removal is both possible and safe. Overall, evidence supports that early chest tube removal is well-tolerated and doesn't increase the risk of complications for those meeting specific criteria. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about early chest tube removal for lung surgery because it could significantly improve patient comfort and recovery time. Unlike the standard post-operative care, which involves keeping the chest tube in place for extended periods, this new approach removes the tube just three hours after surgery. This method has the potential to reduce pain, lower the risk of infection, and allow patients to return to normal activities sooner. Overall, it represents a shift towards more patient-friendly recovery protocols in lung surgery.

What evidence suggests that early chest tube removal is effective for lung surgery?

This trial will compare early chest tube removal with standard post-operative care. Research has shown that removing chest tubes soon after lung surgery can be safe and beneficial. Studies found that patients who had their chest tubes removed within 6 hours after surgery experienced fewer complications and reduced hospital stays. Another study discovered that same-day chest tube removal often resulted in just a one-day hospital stay. A combined analysis of several studies confirmed that early removal is safe and feasible, even for patients with significant fluid drainage. Overall, these findings suggest that early chest tube removal can enhance recovery after lung surgery. ^{1 2 4 6 7}

Who Is on the Research Team?

Rahul Nayak, MD MSc

Principal Investigator

Western University

Are You a Good Fit for This Trial?

This trial is for patients who have undergone a minimally invasive lung surgery called VATS. It's testing if it's safe and possible to remove the chest tube on the same day of surgery, which could enhance recovery.

Inclusion Criteria

I am scheduled for a specific lung surgery.

Exclusion Criteria

I have had a procedure to fuse the layers of my lung lining.

My surgery was changed to an open chest operation while in progress.

I cannot complete daily tasks due to a cognitive disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo Video Assisted Thoracic Surgery (VATS) with early chest tube removal at 3 hours post-operation

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of complications and quality of life

30 days

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Early Chest Tube Removal

Trial Overview The study is examining the outcomes when chest tubes are removed early after Video Assisted Thoracic Surgery (VATS). The goal is to see if this can be part of an improved recovery protocol.

How Is the Trial Designed?

Group I: Early Chest Tube Removal Experimental Treatment 1 Intervention

early chest tube removal at 3 hours

Group II: Standard of Care Active Control 1 Intervention

Routine post operative chest tube care

Who Is Running the Clinical Trial?

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

678

Recruited

421,000+

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

668

Recruited

424,000+

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

686

Recruited

427,000+

Published Research Related to This Trial

In a study of 136 patients who underwent thoracoscopic lobectomy, early removal of the chest tube the day after surgery was found to be safe, regardless of the drainage volume, as it did not increase the risk of complications.

Factors such as tumor location, advanced disease stage, and the extent of lung resection were more strongly associated with complications than the amount of drainage, suggesting that drainage volume alone should not dictate the timing of chest tube removal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective study of the association between drainage volume within 24 hours after thoracoscopic lobectomy and postoperative morbidity. Nakanishi, R., Fujino, Y., Yamashita, T., et al.[2022]

In a study of 126 patients with stage I lung cancer undergoing uniportal video-assisted thoracic surgery, early removal of the pigtail catheter within 24 hours post-surgery was found to be safe and feasible, with no significant complications requiring tube reinsertion for pneumothorax during the 30-day follow-up.

Patients who had their chest tubes removed within 24 hours experienced significantly less pain on the third postoperative day compared to those who had their tubes removed after 24 hours, suggesting that early removal may enhance recovery comfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The short-term outcomes for the early removal of pigtail catheter drainage within 24 hours of uniportal video-assisted anatomic surgery in patients with lung cancer. Zheng, S., Shi, Q., Ma, Q., et al.[2022]

In a study of 1232 patients who underwent cardiac surgery, early removal of chest tubes (around midnight) was linked to a higher risk of developing postoperative pleural and/or pericardial effusions requiring invasive treatment, with a relative risk of 1.70.

Patients who had their chest tubes removed early had a 20% incidence of complications compared to 13% in those who had tubes removed the following morning, suggesting that delaying removal may enhance patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early chest tube removal following cardiac surgery is associated with pleural and/or pericardial effusions requiring invasive treatment. Andreasen, JJ., Sørensen, GV., Abrahamsen, ER., et al.[2015]

In a study of 162 patients undergoing thoracoscopic lung resection, a no-drain policy was found to be safe, with no postoperative mortality or need for redrainage in patients who had their chest tubes removed immediately after surgery.

Patients who did not have chest tubes placed experienced shorter hospital stays and less postoperative pain compared to those who did, suggesting that omitting chest tube drainage can enhance recovery after lung surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Validation of a No-Drain Policy After Thoracoscopic Major Lung Resection. Murakami, J., Ueda, K., Tanaka, T., et al.[2022]

A study involving 70 patients who underwent lobectomies found that early removal of chest tubes (when drainage was less than 300 ml/24 h) is feasible and safe, leading to a shorter chest tube duration (44 hours vs. 67 hours) and reduced hospital stay (5.0 days vs. 6.0 days).

There were no significant differences in complications or pleural effusions between the early removal group and the traditional management group, indicating that early chest tube removal does not increase the risk of postoperative issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Early removal of the chest tube after lobectomies: a prospective randomized control study]. Zhang, Y., Li, H., Hu, B., et al.[2013]

In a study of 126 patients who underwent pulmonary segmentectomy, 75% were safely discharged with a chest tube, demonstrating that outpatient management of chest tubes is feasible and effective.

Out of those discharged with a chest tube, 95% had successful management without life-threatening complications, indicating that this approach can significantly reduce hospital stays while maintaining patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of early discharge with a chest tube after pulmonary segmentectomy. Bao, F., Dimitrovska, NT., Hu, S., et al.[2021]

In a study of 100 patients undergoing thoracoscopic lung surgery, early chest tube removal on postoperative day 0 was found to be safe, with no cases of pneumothorax requiring reinsertion and only one readmission for delayed pleural effusion.

Patients who had their chest tubes removed on POD 0 experienced a shorter hospital stay (median of 1 day) and higher compliance with an opioid-free pain management protocol (75%) compared to those who had tubes removed later, indicating potential benefits for recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early postoperative day 0 chest tube removal using a digital drainage device protocol after thoracoscopic major pulmonary resection. Pfeuty, K., Lenot, B.[2021]

In a study of 162 patients who underwent thoracoscopic lobectomy, early chest tube removal the day after surgery was found to be safe, regardless of the drainage volume, as long as there was no air leakage or problematic pleural effusion.

The research indicated that drainage volume did not correlate with the risk of complications, although patients with a drainage volume of 350 mL or more should be monitored closely.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early chest tube removal after thoracoscopic lobectomy with the aid of an additional thin tube: a prospective multi-institutional study. Nakanishi, R., Fujino, Y., Kato, M., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11170371/

Early chest tube removal within 6 hours after thoracic ... Of the 942 patient charts reviewed, 244 (25.9%) met the criteria for chest tube removal within 6 hours postoperatively. This patient group did ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7049017/

Early removal of chest tubes leads to better short-term ... In light of earlier findings, some surgeons believed that early removal of a chest tube reduces length of hospital stay and decreases complications after VATS ...

3. jtd.amegroups.org jtd.amegroups.org/article/view/99321/html

Early versus late chest tube removal after surgery for primary ... Recent studies showed that chest tube removal on the same day of surgery is safe with a mean postoperative LOS of one day in patients operated for PSP (9,10).

4. sciencedirect.com sciencedirect.com/science/article/pii/S2666273623003005

The process and safety of removing chest tubes 4 to 12 ... In 2018, we removed 29.6% (32/108) of patients' chest tubes within 4 to 12 hours versus 93.3% (194/208) in 2022. The percentage of chest tubes removed early was ...

5. journals.lww.com journals.lww.com/md-journal/fulltext/2023/03240/efficacy_and_safety_of_early_chest_tube_removal.50.aspx

Efficacy and safety of early chest tube removal after... This meta-analysis revealed that it is feasible and safe to remove a chest tube with high-output drainage after pulmonary resection for selected patients.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022522323010073

Early chest tube removal regardless of drainage volume ... Conclusions. Early chest tube removal, regardless of drainage volume, was safe and feasible in patients who underwent anatomic pulmonary resection. Graphical ...

7. jtcvsopen.org jtcvsopen.org/article/S2666-2736(23)00300-5/fulltext

The process and safety of removing chest tubes 4 to 12 ... In 2017, Murakami and colleagues showed that early chest tube removal was feasible and safe after thoracoscopic major pulmonary resection.