Emergency MedicineNCT04366947
Intravascular Access in Suspected/Confirmed COVID-19 Patient
A study testing NIO® (Intraosseous access) in people with Emergency Medicine and Cardiopulmonary Arrest, run by Lazarski University at 1 site in Poland.
Trial summary
The current COVID-19 pandemic, this is especially since the transmission of SARS-CoV-2 is thought to occur mainly through respiratory droplets generated by coughing and sneezing, by direct contact with contaminated surfaces and because in a large number of patients COVID-19 disease may be asymptomatic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergency Medicine, Cardiopulmonary Arrest, Shock
- What is being tested?
- NIO® (Intraosseous access)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- 14 Apr 2020to 30 Oct 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Out-of-hospital cardiac arrest (OHCA)
- Adult ≥ 18 years old
- Non-traumatic cause of cardiac arrest
Who cannot join
- Existing do-not-attempt-resuscitation order
- OHCA patients with contraindications to IO access or IV access
- Patients with signs of obvious death, e.g. rigor mortis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Intraosseous Versus Intravenous Access in Suspected/Confirmed COVID-19 Patient in Prehospital Setting
The current COVID-19 pandemic, this is especially since the transmission of SARS-CoV-2 is thought to occur mainly through respiratory droplets generated by coughing and sneezing, by direct contact with contaminated surfaces and because in a large number of patients COVID-19 disease may be asymptomatic. As recommended by the CDC medical personnel should be equipped with full personal protective equipment (PPE) for AGP in contact with suspected/confirmed COVID-19 patient. Therefore, it is reasonable to search for the most effective methods of intravascular access in those conditions.
- Conditions
- Emergency Medicine, Cardiopulmonary Arrest, Shock
- Being tested
- NIO® (Intraosseous access), Standard of Care (Intravenous access)
- Keywords
- intravascular access, intraosseous access, personal protective equipment, cardiopulmonary resuscitation, shock
- Medical subject headings
- Heart Arrest, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIO® (Intraosseous access)Device
Also called IO
obtaining intravascular access using a ready intravenous NIO needle set
Standard of Care (Intravenous access)Device
Also called IV
obtaining intravascular access using a standard intravenous cannula
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care (Intravenous Cannula) | Experimental | obtaining intravascular access using a ready standard intravenous cannula Receives: Device: Standard of Care (Intravenous access) |
| Experimental: IO access using NIO® set | Experimental | receive an IO line in the proximal tibia localization. IO lines are placed using an FDA-approved device called an NIO®. Receives: Device: NIO® (Intraosseous access) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of first intravascular access attempt
successful placement of intravascular device
Measured: 1 day
Secondary outcomes (5)
time to successful access
time to successful access
Measured: 1 day
number of attempts to successful access
number of attempts to successful access
Measured: 1 day
time to infusion
time to therapy including but not limited to time to fluids, antibiotics, and antiarrythmics
Measured: 1 day
complication rates
complication rates
Measured: 1 day
ROSC
the rate of survival to hospital admission
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 posted29 Apr 2020
- Study start14 Apr 2020
- Primary completion20 Sep 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergency MedicineStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lazarski University
- Sponsor type
- University, hospital or other
- Collaborators
- Poznan University of Medical Sciences, Medical University of Bialystok, Wroclaw Medical University
- Responsible party
- Principal investigator, Lukasz Szarpak, Lazarski University
- Investigators
- Lukasz Szarpak, PhD, Study chair, Lazarski University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04366947
- Sponsor's protocol ID
- IO_PPE_1
- Status last verified
- Dec 2020
- First submitted
- 23 Apr 2020
- Last updated
- 19 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: the investigators will decide after study finishing
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intraosseous Versus Intravenous Access in Suspected/Confirmed COVID-19 Patient in Prehospital Setting
- ClinicalTrials.gov ID
- NCT04366947
- Acronym / sponsor ID
- IO_PPE_1
- Conditions
- Emergency Medicine, Cardiopulmonary Arrest, Shock
- Keywords
- intravascular access, intraosseous access, personal protective equipment, cardiopulmonary resuscitation, shock
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Lazarski UniversityUniversity, hospital or other
- Collaborators
- Poznan University of Medical Sciences, Medical University of Bialystok, Wroclaw Medical University
- Study start
- 14 Apr 2020 (actual)
- Primary completion
- 20 Sep 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 29 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.
The current COVID-19 pandemic, this is especially since the transmission of SARS-CoV-2 is thought to occur mainly through respiratory droplets generated by coughing and sneezing, by direct contact with contaminated surfaces and because in a large number of patients COVID-19 disease may be asymptomatic. As recommended by the CDC medical personnel should be equipped with full personal protective equipment (PPE) for AGP in contact with suspected/confirmed COVID-19 patient. Therefore, it is reasonable to search for the most effective methods of intravascular access in those conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (Intravenous Cannula) | Experimental | Device: Standard of Care (Intravenous access)obtaining intravascular access using a ready standard intravenous cannula |
| Experimental: IO access using NIO® set | Experimental | Device: NIO® (Intraosseous access)receive an IO line in the proximal tibia localization. IO lines are placed using an FDA-approved device called an NIO®. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Out-of-hospital cardiac arrest (OHCA)
- Adult ≥ 18 years old
- Non-traumatic cause of cardiac arrest
Key exclusion criteria (3 listed)
- Existing do-not-attempt-resuscitation order
- OHCA patients with contraindications to IO access or IV access
- Patients with signs of obvious death, e.g. rigor mortis
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 |
|---|---|---|
| NIO® (Intraosseous access)Also: IOobtaining intravascular access using a ready intravenous NIO needle set | Device | Experimental: IO access using NIO® set |
| Standard of Care (Intravenous access)Also: IVobtaining intravascular access using a standard intravenous cannula | Device | Standard of Care (Intravenous Cannula) |
Primary outcome
Success rate of first intravascular access attempt
Time frame: 1 day
successful placement of intravascular device
5 secondary outcomes
time to successful access
Time frame: 1 day
number of attempts to successful access
Time frame: 1 day
time to infusion
Time frame: 1 day
complication rates
Time frame: 1 day
ROSC
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 19 Dec 2020.
- Individual participant dataSharing planned: Undecided. the investigators will decide after study finishing
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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.
Lukasz Szarpak, PhD study chair
Lazarski University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIO® (Intraosseous access) in people with Emergency Medicine and Cardiopulmonary Arrest, 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 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: finished, as of the sponsor's last update on 19 Dec 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?
Success rate of first intravascular access attempt (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 19 Dec 2020.