A Phase 3 interventional study of Reactor Device and Tube thoracostomy in Pneumothorax and Hemothorax, sponsored by Crozer-Keystone Health System. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-08.
Sponsored by Crozer-Keystone Health System · Phase 3, Interventional, and Treatment
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.
183 studies on the registry are indexed under Pneumothorax; 41 are open to participants now.
This study's planned enrollment of 54 is below the median of 100 across 111 interventional studies indexed under Pneumothorax.
Browse Pneumothorax studies →Crozer-Keystone Health System is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Procedure: Tube thoracostomy
Device: Reactor Device
The Reactor is a Class II FDA medical device to facilitate the insertion of chest tubes into the thoracic cavity.
Traditional chest tube placement
Patient report of pain
As measured on a 100mm VAS
Time frame: During procedure
Procedure time
Time frame: During procedure
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Crozer-Keystone Health System