The Development and Experimental Application of a New Thoracostomy Trocar

NCT ID: NCT02543138

Last Updated: 2015-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2015-08-31

Brief Summary

Traditional closed thoracostomy exhibit certain shortcomings. Blind dissection is a lengthy process that is difficult for unskilled physicians, whereas the use of a traditional trocar is relatively likely to damage internal organs. In this study, investigators developed a new trocar and examined its usefulness.

Detailed Description

The new trocar consists of a mold and a stylet; the mold has a hole in its side to ensure that the chest tube proceeds in only one direction. The mold also has a mark to indicate insertion depth. Sixteen participants without experience with thoracostomies observed one closed thoracostomy procedure using the new trocar and then performed three thoracostomies on a cadaver. For each of these thoracostomies, investigators measured the time required for chest tube insertion, the position of the tip of the chest tube within the thoracic cavity, the difficulty associated with the procedure, and the volunteer's confidence after the procedure.

Conditions

Pneumothorax

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: SINGLE

Study Groups

Closed thoracostomy

Closed thoracostomy using the new trocar by novice

Group Type: EXPERIMENTAL

Trocar

Intervention Type: DEVICE

Closed thoracostomy using the new trocar

Interventions

Trocar

Closed thoracostomy using the new trocar

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Senior medical students without prior experience with closed thoracostomies

Exclusion Criteria

• Wrist disease, Pregnancy, Do not want to participate

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hanyang University

OTHER

Sponsor Role: lead

Responsible Party

LEE YOON-JE

Clinical Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

YOON-JE LEE, Master

Role: PRINCIPAL_INVESTIGATOR

Hanyang University

Locations

Hanyang University, College of Medicine

Seoul, , South Korea

Countries

South Korea

References

Lee YJ, Choi HJ, Lim TH, Lee SH, Hwang SJ. The development and experimental application of a new thoracostomy trocar. Am J Emerg Med. 2016 May;34(5):917-20. doi: 10.1016/j.ajem.2016.02.016. Epub 2016 Feb 12. No abstract available.

Reference Type: DERIVED

PMID: 26964824 (View on PubMed)

Other Identifiers

LEE YOON-JE

Identifier Type: -

Identifier Source: org_study_id