Tension PneumothoraxNCT02709122
Are EMS Personnel Prepared to Identify and Decompression of Tension Pneumothorax
A study testing ThoraQuik atraumatic set for pneumothorax decompression in people with Tension Pneumothorax, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
The study aims to determine the level of knowledge and skills to recognize and decompression of tension pneumothorax Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tension Pneumothorax
- What is being tested?
- ThoraQuik atraumatic set for pneumothorax decompression
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePoland
- Study dates
- Feb 2016to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- give voluntary consent to participate in the study
- maximum 1 year of work experience in medicine
- paramedics, nurses, physicians
Who cannot join
- not meet the above criteria
- wrist or low back diseases
- pregnancy
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Medical University of Warsaw, Department of Emergency Medicine
Warsaw, Masovia, 02-005
Lukasz Szarpak, PhD, +48500186225, lukasz.szarpak@gmail.com
About this study
Official title: Are EMS Personnel Prepared to Identify and Decompression of Tension Pneumothorax: A Randomized, Crossover Manikin Trial
The study aims to determine the level of knowledge and skills to recognize and decompression of tension pneumothorax
- Conditions
- Tension Pneumothorax
- Being tested
- ThoraQuik atraumatic set for pneumothorax decompression
- Medical subject headings
- Pneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThoraQuik atraumatic set for pneumothorax decompressionDevice
pneumothorax decompression in case it is found in accordance with the actually recommendations
| Study group | Role | What they receive |
|---|---|---|
| With Tension pneumothorax | Experimental | evaluation of the patient with the existing tension pneumothorax during a simulated CPR - breathing Receives: 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 Receives: Device: ThoraQuik atraumatic set for pneumothorax decompression |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: intraoperative
Secondary outcomes (3)
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.
Measured: intraoperative
duration of the procedure
The time starts from the moment of finding of pneumothorax and ends after its proper decompression
Measured: intraoperative
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)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionMar 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tension PneumothoraxStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Łukasz Szarpak, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02709122
- Sponsor's protocol ID
- 02.010.1MR
- Status last verified
- Mar 2016
- First submitted
- 22 Feb 2016
- Last updated
- 15 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are EMS Personnel Prepared to Identify and Decompression of Tension Pneumothorax: A Randomized, Crossover Manikin Trial
- ClinicalTrials.gov ID
- NCT02709122
- Acronym / sponsor ID
- 02.010.1MR
- Conditions
- Tension Pneumothorax
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 15 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to determine the level of knowledge and skills to recognize and decompression of tension pneumothorax
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With Tension pneumothorax | Experimental | Device: ThoraQuik atraumatic set for pneumothorax decompressionevaluation of the patient with the existing tension pneumothorax during a simulated CPR - breathing |
| Without Tension pneumothorax | Experimental | Device: ThoraQuik atraumatic set for pneumothorax decompressionevaluation of the patient without the existing tension pneumothorax during a simulated CPR - breathing |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- give voluntary consent to participate in the study
- maximum 1 year of work experience in medicine
- paramedics, nurses, physicians
Key exclusion criteria (3 listed)
- not meet the above criteria
- wrist or low back diseases
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThoraQuik atraumatic set for pneumothorax decompressionpneumothorax decompression in case it is found in accordance with the actually recommendations | Device | With Tension pneumothorax, Without Tension pneumothorax |
Primary outcome
physiological parameter
Time frame: intraoperative
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
3 secondary outcomes
Procedure of Pneumothorax decompression
Time frame: intraoperative
duration of the procedure
Time frame: intraoperative
Ease-of-use assessed on a visual analog scale
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2016.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ThoraQuik atraumatic set for pneumothorax decompression in people with Tension Pneumothorax, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lukasz Szarpak, PhD (+48500186225, lukasz.szarpak@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
physiological parameter (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2016.