Rapid Rollover for Pneumothorax

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of California, San Francisco, San Francisco, CA
Pneumothorax+1 More
Rapid Rollover - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

Pneumothorax is the most common complication after CT-guided lung biopsy, and several techniques have been proposed to reduce the risk. Among them, rapid rollover is the maneuver to immediately reposition the patient, with biopsy-side down after removal of biopsy needle. It has been theorized that the technique reduces the size of alveoli surrounding the needle tract, leading to airway closure and reduction in the alveolar-to-pleural pressure gradient, thereby preventing pneumothorax. The aim of this study is to evaluate the effectiveness of rapid rollover in reducing the risk of radiographically detectable pneumothorax and the rate of chest tube insertion. Patients undergoing CT-guided lung biopsy for any indication will be recruited and randomized into either rapid rollover group or control group. In the control group, CT guided lung biopsy will be performed per standard protocols; in the rapid rollover group, the biopsy will also be performed per the same protocol with the addition of rapid rollover at the end of the procedure. For both groups, the primary outcome would be new or enlarging pneumothorax detected on post-biopsy radiographs, and the secondary outcome would be the risk of pneumothorax necessitating chest tube insertion, all complications associated with CT guided lung biopsy, time to complication development, and patient experience in each arm.

Eligible Conditions

  • Pneumothorax
  • Lung Cancers

Treatment Effectiveness

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 24 hours for overnight observation

2 hours after biopsy
Radiographically detectable pneumothorax
Hour 24
Chest tube insertion
Hour 2
Enlarging pneumothorax

Trial Safety

Trial Design

2 Treatment Groups

Control
1 of 2
Rapid Rollover
1 of 2
Active Control
Experimental Treatment

126 Total Participants · 2 Treatment Groups

Primary Treatment: Rapid Rollover · No Placebo Group · N/A

Rapid Rollover
Procedure
Experimental Group · 1 Intervention: Rapid Rollover · Intervention Types: Procedure
ControlNoIntervention Group · 1 Intervention: Control · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 hours for overnight observation
Closest Location: University of California, San Francisco · San Francisco, CA
Photo of San Francisco 1Photo of San Francisco 2Photo of San Francisco 3
2008First Recorded Clinical Trial
1 TrialsResearching Pneumothorax
689 CompletedClinical Trials

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,246 Previous Clinical Trials
11,473,548 Total Patients Enrolled
Jae Ho Sohn, MDPrincipal InvestigatorUniversity of California, San Francisco

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References