Back to results

Are EMS Personnel Prepared to Identify and Decompression of Tension Pneumothorax

Primary Purpose

Tension Pneumothorax

Status

Unknown status

Phase

Not Applicable

Locations

Poland

Study Type

Interventional

Intervention

ThoraQuik atraumatic set for pneumothorax decompression

About this trial

This is an interventional treatment trial for Tension Pneumothorax

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

not meet the above criteria
wrist or low back diseases
pregnancy

Sites / Locations

Medical University of Warsaw, Department of Emergency MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

With Tension pneumothorax

Without Tension pneumothorax

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Procedure of Pneumothorax decompression

Pneumothorax decompression should be in the 2-3 intercostal space at the upper edge of the rib. subject to evaluation will place the introduction of the cannula.

duration of the procedure

The time starts from the moment of finding of pneumothorax and ends after its proper decompression

Ease-of-use assessed on a visual analog scale

To access subjective opinion about the difficulty of pneumothorax decompression, participants were asked to rate it on a visual analog scale (VAS) with a score from 1 (extremely easy) to 10 (extremely difficult)

Full Information

NCT ID

NCT02709122

First Posted

February 22, 2016

Last Updated

March 9, 2016

Sponsor

Medical University of Warsaw

1. Study Identification

Unique Protocol Identification Number

NCT02709122

Brief Title

Are EMS Personnel Prepared to Identify and Decompression of Tension Pneumothorax

Official Title

Are EMS Personnel Prepared to Identify and Decompression of Tension Pneumothorax: A Randomized, Crossover Manikin Trial

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Unknown status

Study Start Date

February 2016 (undefined)

Primary Completion Date

March 2016 (Anticipated)

Study Completion Date

March 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of Warsaw

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tension Pneumothorax

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

With Tension pneumothorax

Arm Type

Experimental

Arm Description

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

Arm Title

Without Tension pneumothorax

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

ThoraQuik atraumatic set for pneumothorax decompression

Intervention Description

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

Primary Outcome Measure Information:

Title

physiological parameter

Description

Time Frame

intraoperative

Secondary Outcome Measure Information:

Title

Procedure of Pneumothorax decompression

Description

Pneumothorax decompression should be in the 2-3 intercostal space at the upper edge of the rib. subject to evaluation will place the introduction of the cannula.

Time Frame

intraoperative

Title

duration of the procedure

Description

The time starts from the moment of finding of pneumothorax and ends after its proper decompression

Time Frame

intraoperative

Title

Ease-of-use assessed on a visual analog scale

Description

Time Frame

1 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: give voluntary consent to participate in the study maximum 1 year of work experience in medicine paramedics, nurses, physicians Exclusion Criteria: not meet the above criteria wrist or low back diseases pregnancy

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lukasz Szarpak, PhD

Phone

+48500186225

lukasz.szarpak@gmail.com

Facility Information:

Facility Name

Medical University of Warsaw, Department of Emergency Medicine

City

Warsaw

State/Province

Masovia

ZIP/Postal Code

02-005

Country

Poland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lukasz Szarpak, PhD

Phone

+48500186225

lukasz.szarpak@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Are EMS Personnel Prepared to Identify and Decompression of Tension Pneumothorax

We'll reach out to this number within 24 hrs