Early Chest Tube Removal After Surgery for Primary Spontaneous Pneumothorax: A Randomized Controlled Trial

Primary Spontaneous Pneumothorax Clinical Trial

Official title:

Early Chest Tube Removal After Surgery for Primary Spontaneous Pneumothorax: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06411431
• Other study ID #: PSP-RCT
• Status: Recruiting
• Phase: N/A
• Start date: October 3, 2023
• Est. completion date: December 2027

Study information

• Verified date: November 2023
• Source: Swedish Medical Center
• Contact: Brian Louie, M.D.
• Phone: 206-215-6800
• Email: brian.louie[@]swedish.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 removal

Participants 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

Description:

This study will be a multicentered randomized controlled trial. The trial will recruit all adult subjects (>18 years old) with PSP who are undergoing VATS blebectomy/wedge resection with chemical pleurodesis from participating centers. Subjects will be identified by the surgical team when evaluating a subject with PSP for surgery. If screened eligible and not meeting an exclusion criterion, the trial will be discussed with them, and consent will be obtained.

Subjects will undergo VATS with resection of all visible disease or an apical wedge resection if none is found. The use of reinforced or non-reinforced staple loads is left to surgeons' preference. For pleurodesis, choice of chemical agent is at the desecration of the surgeon and common practice but limited to 3 agents (talc, dextrose, or a tetracycline antibiotic). Surgeons can choose to perform a mechanical pleurodesis as they deem appropriate. A single apical chest tube will be placed and connected to a suction device set to at least -20 mmHg of suction. Subjects will then be admitted overnight.

Subjects will be re-evaluated on the morning of POD#1. Those without an air leak, with <400 cc of non-bloody chest tube output, and having a maximum 1cm of apical pleural separation (as determined by the surgeon) will be eligible for randomization to either early or standard removal of their chest tube.

Randomization will occur in a 1:1 manner, stratified by participating center. Subjects within the "Early Removal" group will have their chest tube removed on postoperative day 1 within 24 hours from the end of the surgery with a follow-up chest x-ray within 6 hours from removal in addition to monitoring of symptoms. If the subject remains stable without developing symptoms (new oxygen requirement, shortness of breath, etc.) or increased pleural separation on x-ray, they will be eligible for discharge with appropriate follow-up.

Subjects in the "Standard Removal" group will keep their chest tube to suction until postoperative day 2. The chest tube would be removed on POD#2 with a follow up chest x-ray within 6 hours. If the subject remains stable without developing symptoms (new oxygen requirement, shortness of breath, etc.) or growth of pleural separation on chest x-ray, they would be eligible for discharge.

Subjects will then follow up in clinic within 2 weeks of the operation with a chest x-ray. A 3-month follow-up phone call will be performed. At 1-year post-operative, subjects again will have standard clinic follow up and chest x-ray. Finally, a 2 year follow up phone call and chest x-ray will be completed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2027
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient undergoing video assisted thoracoscopic surgery with blebectomy/wedge resection and chemical pleurodesis for primary spontaneous pneumothorax

• Adult patients (> 18 years)

Exclusion Criteria:

• Subjects with history of chest radiation or prior ipsilateral chest surgery

• Tuberculosis or other infectious etiology

• Secondary spontaneous pneumothorax (COPD, cancer, cystic fibrosis, connective tissue disease, sarcoidosis, catamenial, etc.)

• Pneumothorax due to trauma

• Hemothorax or hydropneumothorax

• Immunocompromised subjects: neutropenic, leukopenia, or subjects taking immunosuppressive medication such as chemotherapy, transplant medications, steroid (=5 mg of prednisone or equivalent), etc.

• Interstitial lung disease

• Children (<18)

• Pregnant women

• Adults unable to consent for themselves

• Prisoners

Related Conditions & MeSH terms

• Pneumothorax
• Primary Spontaneous Pneumothorax

Intervention

Procedure:
• Early Chest Tube Removal
Subjects within the "Early Removal" group will have their chest tube removed if the following criteria are met on the morning of POD#1: =1 cm of apical pleural separation and no other areas of pleural separation No air leak No bloody output or concern for bleeding < 400cc of drainage
• Standard Chest Tube Removal
Subjects within the "Standard Removal" group will have their chest tube removal on POD#2 if the following criteria are met on the morning of POD#1: =1 cm of apical pleural separation and no other areas of pleural separation No air leak No bloody output or concern for bleeding < 400cc of drainage

Device:
• Apical Chest Tube
A single apical chest tube will be placed and connected to a suction device at least -20 mmHg suction.

Locations

Country	Name	City	State
United States	Swedish Cancer Institute	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Swedish Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of Pneumothorax		2 years from surgery
Secondary	Postoperative Length of Stay	Postoperative length of stay is defined from the end of the operation until discharge.	End of Surgery to Discharge, up to 90 days
Secondary	Total length of stay	Total length of stay is defined as the time from admission until time subject is discharged.	Admission to Discharge, up to 90 days
Secondary	Chest Tube Duration	From the end of the operation until the removal of the chest tube placed at the initial VATS with pleurodesis.	End of surgery to removal of chest tube, up to 90 days
Secondary	Complications	Complications post-surgery such as pleural separation, pleural effusion, hemothorax, etc.	2 years from surgery
Secondary	Need for interventions	Need for additional interventions post-surgery such as thoracentesis, chest tube placement, etc.	2 years from surgery