Reactor Thoracostomy (UNCUT)
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|ClinicalTrials.gov Identifier: NCT03769727|
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : April 17, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Pneumothorax Hemothorax||Device: Reactor Device Procedure: Tube Thoracostomy||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Use of a Novel Chest Tube Insertion Device for Urgent Thoracostomy in an Emergency Department Setting|
|Estimated Study Start Date :||May 1, 2019|
|Estimated Primary Completion Date :||July 1, 2019|
|Estimated Study Completion Date :||November 1, 2019|
Active Comparator: Traditional
Procedure: Tube thoracostomy Traditional chest tube placement
Procedure: Tube Thoracostomy
Traditional chest tube placement
Experimental: Reactor Device
Device: Reactor Device The Reactor is a Class II FDA medical device to facilitate the insertion of chest tubes into the thoracic cavity.
Device: Reactor Device
The Reactor is a Class II FDA medical device to facilitate the insertion of chest tubes into the thoracic cavity.
- Patient report of pain [ Time Frame: During procedure ]As measured on a 100mm Visual Analog Scale (VAS), with a patient reported score of 0 representing no pain and 100 representing the worst pain possible. The patient will draw a line crossing the 100mm VAS at one location, with each millimeter representing a whole number (ex. 25mm = score of 25). Each marking will be measured to achieve the pain score on the VAS.
- Procedure time [ Time Frame: During procedure ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03769727
|Contact: Kara B. Goddard, PharmD, BCPSemail@example.com|
|Contact: Matthew T. Robinson, MD, FACEP, FAAEMfirstname.lastname@example.org|
|United States, Missouri|
|University of Missouri Health Care||Recruiting|
|Columbia, Missouri, United States, 65212|
|Contact: Kara B. Goddard, PharmD, BCPS|
|Contact: Matthew T. Robinson, MD, FACEP|
|United States, Pennsylvania|
|Crozer-Keystone Health System||Recruiting|
|Upland, Pennsylvania, United States, 19013|
|Contact: Richard Pescatore, DO, FAAEM|
|Principal Investigator:||Richard Pescatore, DO, FAAEM||Crozer-Keystone Health System|