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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSwedish Medical Center

About 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 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Adult patients (> 18 years)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Early Chest Tube Removal

    Procedure/Surgery

    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

    Procedure/Surgery

    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

  • Apical Chest Tube

    Device

    A single apical chest tube will be placed and connected to a suction device at least -20 mmHg suction.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Early Chest Tube RemovalExperimental treatment 2 interventions
Group B: Standard Chest Tube RemovalActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Recurrence of Pneumothorax

Time frame
2 years from surgery

Secondary outcomes

1

Postoperative Length of Stay

Postoperative length of stay is defined from the end of the operation until discharge.

Time frame
End of Surgery to Discharge, up to 90 days
2

Total length of stay

Total length of stay is defined as the time from admission until time subject is discharged.

Time frame
Admission to Discharge, up to 90 days
3

Chest Tube Duration

From the end of the operation until the removal of the chest tube placed at the initial VATS with pleurodesis.

Time frame
End of surgery to removal of chest tube, up to 90 days
4

Complications

Complications post-surgery such as pleural separation, pleural effusion, hemothorax, etc.

Time frame
2 years from surgery

Other outcomes

Sponsors and contacts

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