Reactor Thoracostomy

Pneumothorax Clinical Trial

— UNCUT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03769727
• Other study ID #: 2013215 MU
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: December 9, 2019

Study information

• Verified date: March 2020
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 9, 2019
• Est. primary completion date: October 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects age = 18 years old

• Attending physician determination of need for urgent tube thoracostomy for treatment of traumatic pneumothorax, hemothorax, or hemopneumothorax.

• Hemodynamically stable

Exclusion Criteria:

• Pregnant patients

• Prisoners

• Need for emergency thoracostomy

• Hemodynamic instability

• Respiratory distress

Related Conditions & MeSH terms

• Hemothorax
• Pneumothorax

Intervention

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

Procedure:
• Tube Thoracostomy
Traditional chest tube placement

Locations

Country	Name	City	State
United States	University of Missouri Health Care	Columbia	Missouri
United States	Crozer-Keystone Health System	Upland	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Missouri-Columbia	Crozer-Keystone Health System, Sharp Medical Products, LLC

Country where clinical trial is conducted

United States, 

References & Publications (7)

Ball CG, Lord J, Laupland KB, Gmora S, Mulloy RH, Ng AK, Schieman C, Kirkpatrick AW. Chest tube complications: how well are we training our residents? Can J Surg. 2007 Dec;50(6):450-8. — View Citation

Cole FJ Jr. Discussion of "Evaluation of a novel thoracic entry device versus needle decompression in a tension pneumothorax swine model". Am J Surg. 2018 May;215(5):836-837. doi: 10.1016/j.amjsurg.2017.11.051. Epub 2018 Jan 13. — View Citation

Hatch Q, Debarros M, Johnson E, Inaba K, Martin M. Standard laparoscopic trocars for the treatment of tension pneumothorax: a superior alternative to needle decompression. J Trauma Acute Care Surg. 2014 Jul;77(1):170-5. doi: 10.1097/TA.0000000000000249. — View Citation

Kuckelman J, Derickson M, Phillips C, Barron M, Marko S, Eckert M, Martin M. Evaluation of a novel thoracic entry device versus needle decompression in a tension pneumothorax swine model. Am J Surg. 2018 May;215(5):832-835. doi: 10.1016/j.amjsurg.2017.12.014. Epub 2018 Jan 5. — View Citation

Laan DV, Vu TD, Thiels CA, Pandian TK, Schiller HJ, Murad MH, Aho JM. Chest wall thickness and decompression failure: A systematic review and meta-analysis comparing anatomic locations in needle thoracostomy. Injury. 2016 Apr;47(4):797-804. doi: 10.1016/j.injury.2015.11.045. Epub 2015 Dec 13. Review. — View Citation

Luketich JD, Kiss M, Hershey J, Urso GK, Wilson J, Bookbinder M, Ginsberg R. Chest tube insertion: a prospective evaluation of pain management. Clin J Pain. 1998 Jun;14(2):152-4. — View Citation

Sethuraman KN, Duong D, Mehta S, Director T, Crawford D, St George J, Rathlev NK. Complications of tube thoracostomy placement in the emergency department. J Emerg Med. 2011 Jan;40(1):14-20. doi: 10.1016/j.jemermed.2008.06.033. Epub 2008 Dec 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient report of pain	As measured on a 100mm Visual Analog Scale (VAS), with a patient reported score of 0 representing no pain and 100 representing the worst pain possible. The patient will draw a line crossing the 100mm VAS at one location, with each millimeter representing a whole number (ex. 25mm = score of 25). Each marking will be measured to achieve the pain score on the VAS.	During procedure
Secondary	Procedure time		During procedure

External Links

•   Reactor