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

NCT06411431 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-05-16

No results posted yet for this study

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

Conditions

  • Primary Spontaneous Pneumothorax

Interventions

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

PROCEDURE

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.

Sponsors & Collaborators

  • Swedish Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-03
Primary Completion
2025-12-31
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06411431 on ClinicalTrials.gov