Reactor Thoracostomy

NCT ID: NCT03734471

Last Updated: 2018-11-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2019-11-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Traditional

Group Type: ACTIVE_COMPARATOR

Tube thoracostomy

Intervention Type: PROCEDURE

Traditional chest tube placement

Reactor Device

Group Type: EXPERIMENTAL

Reactor Device

Intervention Type: DEVICE

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

Interventions

Reactor Device

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

Intervention Type: DEVICE

Tube thoracostomy

Traditional chest tube placement

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Crozer-Keystone Health System

OTHER

Sponsor Role: lead

Responsible Party

Richard Pescatore

Director of Clinical Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

18-025

Identifier Type: -

Identifier Source: org_study_id

NCT03769727

Identifier Type: -

Identifier Source: nct_alias