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OpenTrials
Completed

NCT Number: NCT02543138

The Development and Experimental Application of a New Thoracostomy Trocar

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.

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Key information

Age range

25 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hanyang University, College of Medicine

Seoul, 04763, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Senior medical students without prior experience with closed thoracostomies

Exclusion criteria

  • Wrist disease, Pregnancy, Do not want to participate

Treatment and study plan

Trocar

Device

Closed thoracostomy using the new trocar

Primary outcomes

  1. Time to closed thoracostomy

    Time frame: 5 minutes

Secondary outcomes

  1. The accuracy of the position of the tip of the chest tube

    Time frame: 5 minutes

    Yes or No

Other outcomes

  1. Scale of procedural difficulty

    Time frame: within 2 minutes

    Score range from 0[Easy] to 10 [Difficult]

  2. Scale of procedural confidence

    Time frame: within 2 minutes

    Score range from 0 [confidence : no] to 10 [confidence : yes]

Sponsors and collaborators

Lead sponsor

Hanyang University

Other

Registry information

Acronym: TDEANTT

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Sep 7, 2015
Registry last updated
Sep 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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