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NCT06411431 · ClinicalTrials.gov registry record · NA
Early Chest Tube Removal After Surgery for Primary Spontaneous Pneumothorax: A Randomized Controlled Trial
A NA study of Primary Spontaneous Pneumothorax, sponsored by Swedish Medical Center.
- Recruiting
- Registry status
- NA
- Development phase
- 200
- Enrollment target
- 1
- Study location
NCT06411431 is a NA study of Primary Spontaneous Pneumothorax that is actively recruiting participants, run by Swedish Medical Center. The registered enrollment target is 200 participants. The trial reports 1 study location across 1 state.
The verdict
NCT06411431, a NA study of Primary Spontaneous Pneumothorax, is actively recruiting participants, sponsored by Swedish Medical Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 200 participants
- Enrollment target
- 1
- Study location
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 Studied
Interventions
- PROCEDURE Early Chest Tube Removal
- PROCEDURE Standard Chest Tube Removal
- DEVICE Apical Chest Tube
Study Locations (1)
Washington
- Swedish Cancer Institute - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2023-10-03 |
| Est. Completion | 2027-12 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06411431
The ClinicalTrials.gov registry entry for NCT06411431 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Swedish Medical Center, which has 30 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Primary Spontaneous Pneumothorax appearing as the primary indexed condition, and to 3 interventions - of which Early Chest Tube Removal is the first listed.
NCT06411431 reports 1 study location spanning 1 distinct geographic area - top geographies include Washington.
Frequently Asked Questions
What is clinical trial NCT06411431 about?
NCT06411431 is a clinical study titled "Early Chest Tube Removal After Surgery for Primary Spontaneous Pneumothorax: A Randomized Controlled 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 d...
What is the current status of trial NCT06411431?
This trial is currently recruiting. It is a NA study. The enrollment target is 200 participants. The study started on 2023-10-03. Estimated completion is 2027-12.
What conditions does trial NCT06411431 study?
This clinical trial studies the following conditions: Primary Spontaneous Pneumothorax.
What interventions are being tested in trial NCT06411431?
The interventions under investigation include: Early Chest Tube Removal (PROCEDURE), Standard Chest Tube Removal (PROCEDURE), Apical Chest Tube (DEVICE).
Who is sponsoring clinical trial NCT06411431?
This trial is sponsored by Swedish Medical Center, which has 30 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06411431 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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