Cardiac ArrestPhase 2NICANCT03911908
Impact of NIRS-guided Cardiopulmonary Resuscitation After Cardiac Arrest on Resuscitation Rate
A Phase 2 study testing Cerebral oximetry (near infrared) based CPR-Algorithm in people with Cardiac Arrest and Cardiopulmonary Arrest With Successful Resuscitation, run by Dr. Serge Thal at 1 site in Germany.
Trial summary
Sudden cardiac death is one of the main causes of morbidity and mortality worldwide. Cardiac arrest requires prompt intervention by cardiopulmonary resuscitation (CPR). The resuscitation guidelines are the current recommendations for CPR and are revised by expert panels such as the "European Resuscitation Council… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest, Cardiopulmonary Arrest With Successful Resuscitation, Cerebral Oxygenation
- What is being tested?
- Cerebral oximetry (near infrared) based CPR-Algorithm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2019to 5 May 2023
- Phase
- Phase 2
- 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
- Patients with a cardiac arrest from the age of 18 years (in and out-of-hospital cardiac arrest)
Who cannot join
- post-traumatic cardiac arrest
- non-fitting NIRS sensor (size)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Medical Center of the Johannes Gutenberg-University Mainz
Mainz, Rhineland-Palatinate, 55131
About this study
Official title: Impact of a NIRS-guided Cardiopulmonary Resuscitation Algorithm Compared to the Current ERC-guideline Algorithm on ROSC Rate and Patient Outcome After In-hospital and Out-of-hospital Cardiac Arrest
Sudden cardiac death is one of the main causes of morbidity and mortality worldwide. Cardiac arrest requires prompt intervention by cardiopulmonary resuscitation (CPR). The resuscitation guidelines are the current recommendations for CPR and are revised by expert panels such as the "European Resuscitation Council (ERC)".
Up to now, a parameter for assessing the quality of CPR is missing and further monitoring methods are urgently needed.
Read more
Near-infrared spectroscopy (NIRS) is a portable method for measuring regional oxygen levels in the brain. Recent clinical trials suggest that cerebral oxygenation measured by NIRS may correlate with survival and outcome after cardiac arrest.
The investigators propose that NIRS technology may not only be suitable to determine or predict the outcome of the patients, but could also be a useful tool to guide the CPR providers to optimize the CPR techniques and guide the individual treatments/interventions.
The present study was therefore designed to determine if NIRS guided CPR with the aim to optimize NIRS values is superior compared to the current standard practice according to published CPR guidelines (return of spontaneous circulation [ROSC] rate, short and long-term cerebral performance).
- Conditions
- Cardiac Arrest, Cardiopulmonary Arrest With Successful Resuscitation, Cerebral Oxygenation
- Being tested
- Cerebral oximetry (near infrared) based CPR-Algorithm
- Keywords
- near-infrared spectroscopy, cardiopulmonary resuscitation, cardiac arrest, cerebral oximetry
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebral oximetry (near infrared) based CPR-AlgorithmCombination product
If NIRS values do not increase over time until ROSC (target: >40 % after 10 min), interventions are suggested in a modified CPR/NIRS algorithm.
| Study group | Role | What they receive |
|---|---|---|
| ERC guided CPR (intervention/NIRS group) | Active comparator | CPR protocol according to current ERC guidelines (2015) Receives: Combination Product: Cerebral oximetry (near infrared) based CPR-Algorithm |
| ERC-based CPR (control group) | No intervention | modified CPR protocol based on current ERC guidelines (2015), extended by evaluation of NIRS readings and interventions to optimize CPR quality |
What is being measured
The primary outcome is the main question the study is designed to answer.
successful cardiopulmonary resuscitation (CPR)
Influence of the intervention on the number of patients with successful return of spontaneous circulation (ROSC) during cardiopulmonary resuscitation (CPR) [ROSC: yes/no]
Measured: DAY 1
Secondary outcomes (4)
Time-to-ROSC
Time from start of cardiopulmonary resuscitation (CPR) until successful return of spontaneous circulation (ROSC) [min]
Measured: DAY 1
Cerebral Performance Category (CPC) after successful return of spontaneous circulation (ROSC)
Neurofunctional recovery, total score, range: 1-5
Measured: DAY 30, DAY 180, DAY 360
Glasgow Outcome Scale Extended (GOS-E) after successful return of spontaneous circulation (ROSC)
Neurofunctional recovery, total score, range: 1-8
Measured: DAY 30, DAY 180, DAY 360 after successful return of spontaneous circulation (ROSC)
The Bathel-Index (Barthel) after successful return of spontaneous circulation (ROSC)
Neurofunctional recovery, total score, range: 0-100
Measured: Discharge from intensive care unit (variable time point, depending on condition of patient)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start1 Jul 2019
- Primary completion22 May 2022
- Study completion5 May 2023 (estimated)
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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Does near-infrared spectroscopy (NIRS) technology based advanced cardiac life support improve cardiopulmonary resuscitation (CPR) quality in patients (in-house \[IHCA\] and out-of-hospital cardiac arrest \[OHCA\], randomized enrollment immediately with CPR) and thereby improve return of spontaneous circulation (ROSC) rate (primary outcome) and patient outcome compared to European Resuscitation Council (ERC)-based CPR (concealed NIRS recording).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Serge Thal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Serge Thal, Johannes Gutenberg University Mainz
- Investigators
- Serge C Thal, MD, Principal investigator, Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03911908
- Sponsor's protocol ID
- 2018-13666
- Other IDs
- U1111-1231-2797, 2018
- Acronym
- NICA
- Status last verified
- Mar 2023
- First submitted
- 8 Apr 2019
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a NIRS-guided Cardiopulmonary Resuscitation Algorithm Compared to the Current ERC-guideline Algorithm on ROSC Rate and Patient Outcome After In-hospital and Out-of-hospital Cardiac Arrest
- ClinicalTrials.gov ID
- NCT03911908
- Acronym / sponsor ID
- NICA / 2018-13666
- Conditions
- Cardiac Arrest, Cardiopulmonary Arrest With Successful Resuscitation, Cerebral Oxygenation
- Keywords
- near-infrared spectroscopy, cardiopulmonary resuscitation, cardiac arrest, cerebral oximetry
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Dr. Serge ThalUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 22 May 2022 (actual)
- Study completion
- 5 May 2023 (estimated)
- First posted
- 11 Apr 2019 (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.
Sudden cardiac death is one of the main causes of morbidity and mortality worldwide. Cardiac arrest requires prompt intervention by cardiopulmonary resuscitation (CPR). The resuscitation guidelines are the current recommendations for CPR and are revised by expert panels such as the "European Resuscitation Council (ERC)".
Up to now, a parameter for assessing the quality of CPR is missing and further monitoring methods are urgently needed.
Near-infrared spectroscopy (NIRS) is a portable method for measuring regional oxygen levels in the brain. Recent clinical trials suggest that cerebral oxygenation measured by NIRS may correlate with survival and outcome after cardiac arrest.
The investigators propose that NIRS technology may not only be suitable to determine or predict the outcome of the patients, but could also be a useful tool to guide the CPR providers to optimize the CPR techniques and guide the individual treatments/interventions.
The present study was therefore designed to determine if NIRS guided CPR with the aim to optimize NIRS values is superior compared to the current standard practice according to published CPR guidelines (return of spontaneous circulation [ROSC] rate, short and long-term cerebral performance).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Does near-infrared spectroscopy (NIRS) technology based advanced cardiac life support improve cardiopulmonary resuscitation (CPR) quality in patients (in-house [IHCA] and out-of-hospital cardiac arrest [OHCA], randomized enrollment immediately with CPR) and thereby improve return of spontaneous circulation (ROSC) rate (primary outcome) and patient outcome compared to European Resuscitation Council (ERC)-based CPR (concealed NIRS recording).
| Arm | Type | Receives |
|---|---|---|
| ERC guided CPR (intervention/NIRS group) | Active comparator | Combination Product: Cerebral oximetry (near infrared) based CPR-AlgorithmCPR protocol according to current ERC guidelines (2015) |
| ERC-based CPR (control group) | No intervention | –modified CPR protocol based on current ERC guidelines (2015), extended by evaluation of NIRS readings and interventions to optimize CPR quality |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with a cardiac arrest from the age of 18 years (in and out-of-hospital cardiac arrest)
Key exclusion criteria (2 listed)
- post-traumatic cardiac arrest
- non-fitting NIRS sensor (size)
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 |
|---|---|---|
| Cerebral oximetry (near infrared) based CPR-AlgorithmIf NIRS values do not increase over time until ROSC (target: >40 % after 10 min), interventions are suggested in a modified CPR/NIRS algorithm. | Combination product | ERC guided CPR (intervention/NIRS group) |
Primary outcome
successful cardiopulmonary resuscitation (CPR)
Time frame: DAY 1
Influence of the intervention on the number of patients with successful return of spontaneous circulation (ROSC) during cardiopulmonary resuscitation (CPR) [ROSC: yes/no]
4 secondary outcomes
Time-to-ROSC
Time frame: DAY 1
Cerebral Performance Category (CPC) after successful return of spontaneous circulation (ROSC)
Time frame: DAY 30, DAY 180, DAY 360
Glasgow Outcome Scale Extended (GOS-E) after successful return of spontaneous circulation (ROSC)
Time frame: DAY 30, DAY 180, DAY 360 after successful return of spontaneous circulation (ROSC)
The Bathel-Index (Barthel) after successful return of spontaneous circulation (ROSC)
Time frame: Discharge from intensive care unit (variable time point, depending on condition of patient)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Serge C Thal, MD principal investigator
Department of Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cerebral oximetry (near infrared) based CPR-Algorithm in people with Cardiac Arrest and Cardiopulmonary Arrest With Successful Resuscitation, run by Dr. Serge Thal at 1 site in Germany.
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 1 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: status not confirmed, as of the sponsor's last update on 31 Mar 2023. 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 Germany. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
successful cardiopulmonary resuscitation (CPR) (time frame: DAY 1). 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 31 Mar 2023.