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 study is a single centre, prospective clinical trial evaluating the safety and feasibility of implementing a same day chest tube removal protocol in patients undergoing Video Assisted Thoracic Surgery (VATS) anatomical pulmonary surgery.

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.

Is early chest tube removal generally safe for humans?

Research shows that early chest tube removal after lung surgery is generally safe and can help reduce pain and speed up recovery. However, in some cases, like after a complex lung surgery, there might be risks such as air leaks or fluid buildup, which could delay removal. ^{1 2 3 4 5}

How is the treatment of early chest tube removal for lung surgery different from other treatments?

Early chest tube removal after lung surgery is unique because it aims to reduce postoperative pain and speed up recovery by removing the chest tube sooner than traditional methods, which typically involve keeping the tube in place for a longer period to ensure proper drainage. ^{2 4 6 7 8}

What data supports the effectiveness of the treatment Early Chest Tube Removal for Lung Surgery?

Research suggests that early removal of chest tubes after lung surgery can reduce postoperative pain and speed up recovery, as seen in studies involving early removal of pigtail catheters and chest tubes after lung surgeries. ^{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 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]

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]

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 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 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 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 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. Germany pubmed.ncbi.nlm.nih.gov

Early chest tube removal following cardiac surgery is associated with pleural and/or pericardial effusions requiring invasive treatment. [2015]

2. Netherlands pubmed.ncbi.nlm.nih.gov

The Validation of a No-Drain Policy After Thoracoscopic Major Lung Resection. [2022]

3. China 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. [2022]

4. China pubmed.ncbi.nlm.nih.gov

[Early removal of the chest tube after lobectomies: a prospective randomized control study]. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

A prospective study of the association between drainage volume within 24 hours after thoracoscopic lobectomy and postoperative morbidity. [2022]

6. England pubmed.ncbi.nlm.nih.gov

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

7. Germany pubmed.ncbi.nlm.nih.gov

Safety of early discharge with a chest tube after pulmonary segmentectomy. [2021]

8. Japan 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. [2022]