Reactor Thoracostomy

NCT03734471 — Phase 3, Unknown, 54 participants, Crozer-Keystone Health System

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

Registry	NCT03734471, acronym UNCUT
Status	Unknown
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	54 (Estimated)
Sponsor	Crozer-Keystone Health System (Other)
Conditions	Pneumothorax, Hemothorax
Interventions	Reactor Device, Tube thoracostomy (Device, procedure)
Dates	start 2019-01-01 (estimated), primary completion 2019-07-01 (estimated), completion 2019-11-01 (estimated), first posted 2018-11-08, last updated 2018-11-08

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Traditional	Active comparator	Procedure: Tube thoracostomy
Reactor Device	Experimental	Device: Reactor Device

Reactor Device (Device): The Reactor is a Class II FDA medical device to facilitate the insertion of chest tubes into the thoracic cavity.
Tube thoracostomy (Procedure): Traditional chest tube placement

+Outcome measures

Primary outcomes

Patient report of pain [During procedure]: As measured on a 100mm VAS

Secondary outcomes

Procedure time [During procedure]

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

1. Subjects age ≥ 18 years old
2. Attending physician determination of need for urgent tube thoracostomy for treatment of traumatic pneumothorax, hemothorax, or hemopneumothorax.
3. Hemodynamically stable

Exclusion Criteria:

1. Pregnant patients
2. Prisoners
3. Need for emergency thoracostomy
4. Hemodynamic instability
5. Respiratory distress