NCT02543138

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

August 14, 2015

Completed
24 days until next milestone

First Posted

Study publicly available on registry

September 7, 2015

Completed
Last Updated

September 7, 2015

Status Verified

September 1, 2015

Enrollment Period

Same day

First QC Date

August 14, 2015

Last Update Submit

September 3, 2015

Conditions

Pneumothorax

Outcome Measures

Primary Outcomes (1)

  • Time to closed thoracostomy

    5 minutes

Secondary Outcomes (1)

  • The accuracy of the position of the tip of the chest tube

    5 minutes

Other Outcomes (2)

  • Scale of procedural difficulty

    within 2 minutes

  • Scale of procedural confidence

    within 2 minutes

Study Arms (1)

Closed thoracostomy

EXPERIMENTAL

Closed thoracostomy using the new trocar by novice

Device: Trocar

Interventions

TrocarDEVICE

Closed thoracostomy using the new trocar

Closed thoracostomy

Eligibility Criteria

Age25 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Senior medical students without prior experience with closed thoracostomies

You may not qualify if:

  • Wrist disease, Pregnancy, Do not want to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanyang University, College of Medicine

Seoul, 04763, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 26964824DERIVED

MeSH Terms

Conditions

Pneumothorax

Interventions

Surgical Instruments

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Surgical EquipmentEquipment and Supplies

Study Officials

  • YOON-JE LEE, Master

    Hanyang University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Fellow

Study Record Dates

First Submitted

August 14, 2015

First Posted

September 7, 2015

Study Start

August 1, 2015

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

September 7, 2015

Record last verified: 2015-09

Locations

KR(1)