Reactor Thoracostomy

Pneumothorax Clinical Trial

— UNCUT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03734471
• Other study ID #: 18-025
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: January 1, 2019
• Est. completion date: November 1, 2019

Study information

• Verified date: November 2018
• Source: Crozer-Keystone Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 54
• Est. completion date: November 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemothorax
• Pneumothorax

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Crozer-Keystone Health System

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient report of pain	As measured on a 100mm VAS	During procedure
Secondary	Procedure time		During procedure