The Development and Experimental Application of a New Thoracostomy Trocar

Pneumothorax Clinical Trial

— TDEANTT  

Official title:

The Development and Experimental Application of a New Thoracostomy Trocar

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02543138
• Other study ID #: LEE YOON-JE
• Status: Completed
• Phase: N/A
• First received: August 14, 2015
• Last updated: September 3, 2015
• Start date: August 2015
• Est. completion date: August 2015

Study information

• Verified date: September 2015
• Source: Hanyang University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 30 Years

Eligibility

Inclusion Criteria:

• Senior medical students without prior experience with closed thoracostomies

Exclusion Criteria:

• Wrist disease, Pregnancy, Do not want to participate

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Pneumothorax

Intervention

Device:
• Trocar
Closed thoracostomy using the new trocar

Locations

Country	Name	City	State
Korea, Republic of	Hanyang University, College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanyang University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Scale of procedural difficulty	Score range from 0[Easy] to 10 [Difficult]	within 2 minutes	No
Other	Scale of procedural confidence	Score range from 0 [confidence : no] to 10 [confidence : yes]	within 2 minutes	No
Primary	Time to closed thoracostomy		5 minutes	No
Secondary	The accuracy of the position of the tip of the chest tube	Yes or No	5 minutes	No