200 Participants Needed

Early Chest Tube Removal for Collapsed Lung

JC
Brian Louie, MD profile photo
Overseen ByBrian Louie, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are taking immunosuppressive medications like chemotherapy or steroids, you may not be eligible to participate.

What data supports the effectiveness of early chest tube removal as a treatment for a collapsed lung?

Research suggests that early chest tube removal after certain surgeries, like video-assisted thoracoscopic surgery (a type of lung surgery), can reduce patient discomfort without increasing risks. This implies that early removal might be safe and beneficial in similar situations, such as treating a collapsed lung.12345

Is early chest tube removal generally safe for humans?

Research suggests that early chest tube removal can be safe and may reduce pain and speed up recovery after surgeries like lung and heart operations. However, there is a risk of fluid buildup in the chest that might need further treatment, so it should be done carefully and under medical supervision.13678

How does early chest tube removal differ from standard chest tube removal for a collapsed lung?

Early chest tube removal is unique because it involves taking out the chest tube sooner than usual, which can reduce pain and speed up recovery, but it may also increase the risk of fluid buildup that requires further treatment. This approach contrasts with the standard practice of waiting longer to remove the tube to ensure all air or fluid is drained from the chest.148910

What is the purpose of this trial?

Video-assisted thoracoscopic surgery (VATS) with blebectomy/wedge resection plus pleurodesis is the standard of care for recurrent primary spontaneous pneumothorax (PSP) or, in certain instances, after the first episode. The chest tube from surgery is typically kept to suction until post-operative day (POD) 2 to allow for scarring of the lung to the chest to prevent recurrence. However, the scarring process takes place over a period of weeks and is there no data to support POD#2 as the best time to remove the chest tube. Also, shorter chest tube duration can lower length of stay, patient discomfort, and hospital cost.The goal of this randomized study is to determine if early removal (POD#1) of chest tube after video-assisted thoracoscopic surgery (VATS) with blebectomy/wedge resection plus chemical pleurodesis for primary spontaneous pneumothorax (PSP):* has no worse 2-year recurrence rate compared to standard removal (POD#2)* will lower length of stay compared to standard removal* will result in less complications or re-interventions compared to standard removalParticipants will be asked to join prior to surgery. Following standard-of-care surgery, participants will be screened for randomization. If still eligible, participants will be randomized for early chest tube removal or standard removal. Early Removal will happen within 24 hours after surgery, with Standard Removal happening day 2 after surgery.Participants will follow-up with the study team for 2 years on the following schedule:* In clinic with a chest x-ray 2 weeks after surgery* By phone 3 months after surgery* In clinic with a chest x-ray 1 year after surgery* In clinic with a chest x-ray 2 years after surgery

Eligibility Criteria

This trial is for individuals who have had a lung collapse, known as primary spontaneous pneumothorax, and are undergoing surgery. Participants should be fit for the study before their operation and willing to follow up for 2 years with visits and phone calls.

Inclusion Criteria

I am having surgery for a collapsed lung using a camera and small cuts.
I am over 18 years old.

Exclusion Criteria

I have had chest radiation or surgery on the same side before.
I am under 18 years old.
Pregnant women
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo VATS with blebectomy/wedge resection and pleurodesis, followed by randomization to early or standard chest tube removal

2 days
Inpatient stay

Follow-up

Participants are monitored for safety and effectiveness after treatment with scheduled follow-ups

2 years
In clinic with chest x-ray at 2 weeks, 1 year, and 2 years; phone call at 3 months

Treatment Details

Interventions

  • Early Chest Tube Removal
  • Standard Chest Tube Removal
Trial Overview The study tests if removing the chest tube early (1 day after surgery) is as effective as the standard practice of removal on day 2. It looks at recurrence rates over two years, patient comfort, hospital stay duration, and any complications or additional treatments needed.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Early Chest Tube RemovalExperimental Treatment2 Interventions
Subjects within the "Early Removal" group will have their chest tube removed on POD#1 within 24 hours from the end of the surgery.
Group II: Standard Chest Tube RemovalActive Control2 Interventions
Subjects in the "Standard Removal" group will have their chest tube kept to suction on POD#1 with removal on POD#2.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Swedish Medical Center

Lead Sponsor

Trials
55
Recruited
8,500+

Findings from Research

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.
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 93 patients undergoing video-assisted thoracoscopic surgery (VATS), early chest tube removal within 2 hours post-surgery significantly reduced pain intensity and analgesic requirements compared to conventional management.
Early chest tube removal did not lead to any postoperative complications, while complications were observed in patients with conventional management, suggesting that this approach may enhance patient safety and comfort.
[Early chest tube removal after video-assisted thoracoscopic surgery. Results of a prospective randomized study].Sienel, W., Mueller, J., Eggeling, S., 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.
[Early removal of the chest tube after lobectomies: a prospective randomized control study].Zhang, Y., Li, H., Hu, B., et al.[2013]

References

Early chest tube removal following cardiac surgery is associated with pleural and/or pericardial effusions requiring invasive treatment. [2015]
[Early chest tube removal after video-assisted thoracoscopic surgery. Results of a prospective randomized study]. [2022]
[Early removal of the chest tube after lobectomies: a prospective randomized control study]. [2013]
Postoperative outpatient chest tube management: initial experience with a new portable system. [2007]
Timing of chest tube removal after coronary artery bypass surgery. [2011]
Postoperative pulmonary complications and thoracocentesis associated with early versus late chest tube removal after thoracic esophagectomy with three-field dissection: a propensity score matching analysis. [2018]
Early postoperative day 0 chest tube removal using a digital drainage device protocol after thoracoscopic major pulmonary resection. [2021]
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]
The value of chest radiography after chest tube removal in nonventilated trauma patients: a post-hoc analysis of a multicenter prospective cohort study. [2023]
Tube Thoracostomy (Chest Tube) Removal in Traumatic Patients: What Do We Know? What Can We Do? [2020]
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