Reactor Thoracostomy (UNCUT)

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

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.

Study Overview

• Status: Unknown
• Conditions: Pneumothorax; Hemothorax
• Intervention / Treatment: Procedure: Tube thoracostomy; Device: Reactor Device

• Study Type: Interventional
• Enrollment (Anticipated): 54
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Traditional	Procedure: Tube thoracostomy; Traditional chest tube placement
Experimental: Reactor Device	Device: Reactor Device; The Reactor is a Class II FDA medical device to facilitate the insertion of chest tubes into the thoracic cavity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient report of pain	As measured on a 100mm VAS	During procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
Procedure time	During procedure

Collaborators and Investigators

• Sponsor: Crozer-Keystone Health System

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2019
• Primary Completion (Anticipated): July 1, 2019
• Study Completion (Anticipated): November 1, 2019

Study Registration Dates

• First Submitted: November 6, 2018
• First Submitted That Met QC Criteria: November 6, 2018
• First Posted (Actual): November 8, 2018

Study Record Updates

• Last Update Posted (Actual): November 8, 2018
• Last Update Submitted That Met QC Criteria: November 6, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Pleural Diseases; Hemorrhage; Pneumothorax; Hemothorax
• Other Study ID Numbers: 18-025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes