Reactor Thoracostomy

Phase 3

• Conditions: Pneumothorax; Hemothorax
• Interventions: Procedure: Tube thoracostomy; Device: Reactor Device

• Registration Number: NCT03734471
• Lead Sponsor: Crozer-Keystone Health System

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-11
• Study First Submitted: 2018-11-06
• Study First Submitted QC: 2018-11-06
• Last Update Submitted: 2018-11-06
• Study First Posted: 2018-11-08
• Last Update Posted: 2018-11-08
• Study Start: 2019-01-01
• Primary Completion: 2019-07-01
• Study Completion: 2019-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional	Tube thoracostomy	-
Reactor Device	Reactor Device	-

Primary Outcome Measures

Name	Time	Method
Patient report of pain	During procedure	As measured on a 100mm VAS

Secondary Outcome Measures

Name	Time	Method
Procedure time	During procedure