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Reactor Thoracostomy

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03734471
Acronym
UNCUT
Enrollment
54
Registered
2018-11-08
Start date
2019-01-01
Completion date
2019-11-01
Last updated
2018-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemothorax, Pneumothorax

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.

Interventions

DEVICEReactor Device

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

Traditional chest tube placement

Sponsors

Crozer-Keystone Health System
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Patient report of painDuring procedureAs measured on a 100mm VAS

Secondary

MeasureTime frame
Procedure timeDuring procedure

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026