NCT03734471

Reactor Thoracostomy

Use of a Novel Chest Tube Insertion Device for Urgent Thoracostomy in an Emergency Department Setting

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Crozer-Keystone Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pneumothorax
• Hemothorax

Interventions

Type	Name	Description
DEVICE	Reactor Device	The Reactor is a Class II FDA medical device to facilitate the insertion of chest tubes into the thoracic cavity.
PROCEDURE	Tube thoracostomy	Traditional chest tube placement

Timeline

• Start date: 2019-01-01
• Primary completion: 2019-07-01
• Completion: 2019-11-01
• First posted: 2018-11-08
• Last updated: 2018-11-08

Regulatory

• FDA-regulated device study