NCT02709122

Brief Summary

The study aims to determine the level of knowledge and skills to recognize and decompression of tension pneumothorax

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2016

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2016

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 15, 2016

Completed
Last Updated

March 15, 2016

Status Verified

March 1, 2016

Enrollment Period

29 days

First QC Date

February 22, 2016

Last Update Submit

March 9, 2016

Conditions

Tension Pneumothorax

Outcome Measures

Primary Outcomes (1)

  • physiological parameter

    study correctness diagnose of pneumothorax by listening to it with a stethoscope and palpation method. The sounds will be issued by the software of manikin. Correct interpretation of the physiological parameters will be recorded in the survey questionnaire

    intraoperative

Secondary Outcomes (3)

  • Procedure of Pneumothorax decompression

    intraoperative

  • duration of the procedure

    intraoperative

  • Ease-of-use assessed on a visual analog scale

    1 day

Study Arms (2)

With Tension pneumothorax

EXPERIMENTAL

evaluation of the patient with the existing tension pneumothorax during a simulated CPR - breathing

Device: ThoraQuik atraumatic set for pneumothorax decompression

Without Tension pneumothorax

EXPERIMENTAL

evaluation of the patient without the existing tension pneumothorax during a simulated CPR - breathing

Device: ThoraQuik atraumatic set for pneumothorax decompression

Interventions

ThoraQuik atraumatic set for pneumothorax decompressionDEVICE

pneumothorax decompression in case it is found in accordance with the actually recommendations

With Tension pneumothoraxWithout Tension pneumothorax

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • give voluntary consent to participate in the study
  • maximum 1 year of work experience in medicine
  • paramedics, nurses, physicians

You may not qualify if:

  • not meet the above criteria
  • wrist or low back diseases
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Warsaw, Department of Emergency Medicine

Warsaw, Masovia, 02-005, Poland

RECRUITING

MeSH Terms

Conditions

Pneumothorax

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract Diseases

Central Study Contacts

Lukasz Szarpak, PhD

CONTACT

+48500186225lukasz.szarpak@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lukasz Szarpak

Study Record Dates

First Submitted

February 22, 2016

First Posted

March 15, 2016

Study Start

February 1, 2016

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

March 15, 2016

Record last verified: 2016-03

Locations

PL(1)