Cardiac ArrestNCT04363788
Needle Stick Injuries in Emergency Medical Service Practice
An observational study of Cardiac Arrest and Needle Stick, run by Lazarski University at 1 site in Poland.
Trial summary
During the pandemic era, medical personnel should wear full protective suits. However, they limit the performance of medical procedures. One of the main questions is whether to use double gloves. The study was based on dying gloves used during resuscitation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiac Arrest, Needle Stick, Injuries
- What is being tested?
- double gloves
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 sitePoland
- Study dates
- 28 Feb 2020to 24 Apr 2020
- Phase
- Observational
- 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 Any age
- Child, Adult, Older adult
Study population: Medical profession (paramedics, nurses, physicians) working in Emergency Medical Service performing prehospital advance life support
Who may be able to join
- Give voluntary consent to participate in the study
- Medical profession (paramedics, nurses, physicians) working in Emergency Medical Service
Who cannot join
- Not meet the above criteria
- Wrist or low back diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Should we Use Double Gloves During Procedures With Suspected/Confirmed COVID-19 Patient?
During the pandemic era, medical personnel should wear full protective suits. However, they limit the performance of medical procedures. One of the main questions is whether to use double gloves. The study was based on dying gloves used during resuscitation. The gloves were secured with disposable hermetically sealed pouches and described by one of the EMS team members - each time after resuscitation was completed.
- Conditions
- Cardiac Arrest, Needle Stick, Injuries, Glowe
- Being tested
- double gloves
- Keywords
- needle stick injuries, SARS-CoV-2, COVID-19, personal protective equipment, paramedic, emergency medical service
- Medical subject headings
- Heart Arrest, Needlestick Injuries, Wounds and Injuries, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
double glovesProcedure or surgery
Also called DL
The study was based on dying gloves used during resuscitation. The gloves were secured with disposable hermetically sealed pouches and described by one of the EMS team members - each time after resuscitation was completed.
| Study group | Role | What they receive |
|---|---|---|
| Cardiopulmonary resuscitation | The study was based on dying gloves used during resuscitation. The gloves were secured with disposable hermetically sealed pouches and described by one of the EMS team members - each time after resuscitation was completed. Receives: Procedure: double gloves |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of visible puncture
visible puncture
Measured: 1 day
Secondary outcomes (1)
WLT
Water leak test was used to checking unnoticed gloves damage
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 posted27 Apr 2020
- Study start28 Feb 2020
- Primary completion24 Apr 2020
- Study completion24 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lazarski University
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Bialystok, Poznan University of Medical Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04363788
- Sponsor's protocol ID
- OH_PPE_1
- Status last verified
- Apr 2020
- First submitted
- 23 Apr 2020
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: data will be part of manuscript
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Should we Use Double Gloves During Procedures With Suspected/Confirmed COVID-19 Patient?
- ClinicalTrials.gov ID
- NCT04363788
- Acronym / sponsor ID
- OH_PPE_1
- Conditions
- Cardiac Arrest, Needle Stick, Injuries, Glowe
- Keywords
- needle stick injuries, SARS-CoV-2, COVID-19, personal protective equipment, paramedic, emergency medical service
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Lazarski UniversityUniversity, hospital or other
- Collaborators
- Medical University of Bialystok, Poznan University of Medical Sciences
- Study start
- 28 Feb 2020 (actual)
- Primary completion
- 24 Apr 2020 (actual)
- Study completion
- 24 Apr 2020 (actual)
- First posted
- 27 Apr 2020 (actual)
- 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.
During the pandemic era, medical personnel should wear full protective suits. However, they limit the performance of medical procedures. One of the main questions is whether to use double gloves. The study was based on dying gloves used during resuscitation. The gloves were secured with disposable hermetically sealed pouches and described by one of the EMS team members - each time after resuscitation was completed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiopulmonary resuscitation | – | Procedure: double glovesThe study was based on dying gloves used during resuscitation. The gloves were secured with disposable hermetically sealed pouches and described by one of the EMS team members - each time after resuscitation was completed. |
Who may qualify
- Age groups
- Child, Adult, Older adult
- Study population
- Medical profession (paramedics, nurses, physicians) working in Emergency Medical Service performing prehospital advance life support
Key inclusion criteria (2 listed)
- Give voluntary consent to participate in the study
- Medical profession (paramedics, nurses, physicians) working in Emergency Medical Service
Key exclusion criteria (2 listed)
- Not meet the above criteria
- Wrist or low back diseases
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 |
|---|---|---|
| double glovesAlso: DLThe study was based on dying gloves used during resuscitation. The gloves were secured with disposable hermetically sealed pouches and described by one of the EMS team members - each time after resuscitation was completed. | Procedure or surgery | Cardiopulmonary resuscitation |
Primary outcome
Number of visible puncture
Time frame: 1 day
visible puncture
1 secondary outcome
WLT
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
- Individual participant dataSharing planned: Undecided. data will be part of manuscript
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest and Needle Stick, run by Lazarski University 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 28 Apr 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of visible puncture (time frame: 1 day). 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 28 Apr 2020.