Reactor Thoracostomy

NCT03734471 | Unknown Phase 3 FDA Device

• 1 other identifier: 18-025
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pneumothorax; Hemothorax

Outcome Measures

Primary Outcomes (1)

• Patient report of pain

  As measured on a 100mm VAS

  During procedure

Secondary Outcomes (1)

• Procedure time

  During procedure

Study Arms (2)

Traditional

ACTIVE COMPARATOR

Procedure: Tube thoracostomy

Reactor Device

EXPERIMENTAL

Device: Reactor Device

Interventions

Reactor Device DEVICE

The Reactor is a Class II FDA medical device to facilitate the insertion of chest tubes into the thoracic cavity.

Reactor Device

Tube thoracostomy PROCEDURE

Traditional chest tube placement

Traditional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnant patients
• Prisoners
• Need for emergency thoracostomy
• Hemodynamic instability
• Respiratory distress

Sponsors & Collaborators

• Crozer-Keystone Health System: lead

MeSH Terms

Conditions

Pneumothorax; Hemothorax

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Research

Study Record Dates

• First Submitted: November 6, 2018
• First Posted: November 8, 2018
• Study Start: January 1, 2019
• Primary Completion: July 1, 2019
• Study Completion: November 1, 2019
• Last Updated: November 8, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share