Reactor Thoracostomy (UNCUT)
Primary Purpose
Pneumothorax, Hemothorax
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Reactor Device
Tube thoracostomy
Sponsored by
About this trial
This is an interventional treatment trial for Pneumothorax
Eligibility Criteria
Inclusion Criteria:
- Subjects age ≥ 18 years old
- Attending physician determination of need for urgent tube thoracostomy for treatment of traumatic pneumothorax, hemothorax, or hemopneumothorax.
- Hemodynamically stable
Exclusion Criteria:
- Pregnant patients
- Prisoners
- Need for emergency thoracostomy
- Hemodynamic instability
- Respiratory distress
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Traditional
Reactor Device
Arm Description
Outcomes
Primary Outcome Measures
Patient report of pain
As measured on a 100mm VAS
Secondary Outcome Measures
Procedure time
Full Information
NCT ID
NCT03734471
First Posted
November 6, 2018
Last Updated
November 6, 2018
Sponsor
Crozer-Keystone Health System
1. Study Identification
Unique Protocol Identification Number
NCT03734471
Brief Title
Reactor Thoracostomy
Acronym
UNCUT
Official Title
Use of a Novel Chest Tube Insertion Device for Urgent Thoracostomy in an Emergency Department Setting
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Anticipated)
Primary Completion Date
July 1, 2019 (Anticipated)
Study Completion Date
November 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Crozer-Keystone Health System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Tube thoracostomy is commonly performed in the emergency department for patients suffering from traumatic hemo- or pneumo-thorax. The procedure involves the use of a scalpel incision at the skin followed by blunt dissection through tissue, penetration into the thoracic cavity, dilation of a tract for tube placement, exploration of the thoracic cavity with a gloved finger, and finally insertion of a sterile tube into the intrathoracic space. The procedure is considered extremely painful despite the routine provision of systemic analgesics and local anesthetics.
Cadaver and animal studies have demonstrated the use of the Reactor chest tube device, a squeeze-activated thoracostomy trochar with placement of a clear sheath for chest tube insertion, to decrease procedure time, incision size, and blood loss. Case series and observational reports suggest lower rates of procedural complication and failure as well as increased patient satisfaction due to pain reduction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumothorax, Hemothorax
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Traditional
Arm Type
Active Comparator
Arm Title
Reactor Device
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Reactor Device
Intervention Description
The Reactor is a Class II FDA medical device to facilitate the insertion of chest tubes into the thoracic cavity.
Intervention Type
Procedure
Intervention Name(s)
Tube thoracostomy
Intervention Description
Traditional chest tube placement
Primary Outcome Measure Information:
Title
Patient report of pain
Description
As measured on a 100mm VAS
Time Frame
During procedure
Secondary Outcome Measure Information:
Title
Procedure time
Time Frame
During procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects age ≥ 18 years old
Attending physician determination of need for urgent tube thoracostomy for treatment of traumatic pneumothorax, hemothorax, or hemopneumothorax.
Hemodynamically stable
Exclusion Criteria:
Pregnant patients
Prisoners
Need for emergency thoracostomy
Hemodynamic instability
Respiratory distress
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Reactor Thoracostomy
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