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Reactor Thoracostomy (UNCUT)

C

Crozer Health

Status and phase

Unknown
Phase 3

Conditions

Pneumothorax
Hemothorax

Treatments

Procedure: Tube thoracostomy
Device: Reactor Device

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

54 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

54 participants in 2 patient groups

Traditional
Active Comparator group
Treatment:
Procedure: Tube thoracostomy
Reactor Device
Experimental group
Treatment:
Device: Reactor Device

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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