Death, Sudden, CardiacNCT05383885
Is the Perfusion Index an Accurate Predictor of Return of Spontaneus Circulation in Out-of-hospital Cardiac Arrest
An observational study of Death, Sudden, Cardiac and Perfusion Index, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
Trial summary
The purpose of this pilot feasibility study is to evaluate the ability of the Perfusion Index to predict the return to spontaneous circulation of the out-of-hospital cardiac arrest patient during cardiopulmonary resuscitation. Read more about this study
- Who is it for?
- Ages 12 to 99 years
- Conditions the study is for
- Death, Sudden, Cardiac, Perfusion Index, Return of Spontaneous Circulation
- How many people
- 90 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2022to 31 Dec 2023
- 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 12 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient with out-of-hospital or in-hospital cardiac arrest will be assessed for eligibility. After verifiying inclusion and exclusion criteria patients will be included in the study.
Who may be able to join
- Out of hospital cardiac arrest with an indication to initiate chest compressions
- In hospital cardiac arrest with an indication to initiate chest compressions
Who cannot join
- Pregnant patients
- Prisoners
Trial locations and contacts
1 site in 1 country.
Diane De Longueville, MD contact
Belgium1 site, 1 recruiting
- Recruiting
Centre Hospitalier Saint Pierre
Brussels, 1000
Stefano Malinverni, MD, Ph.D, 0471268267, stefano.malinverni@stpierre-bru.be
About this study
Official title: A Prospective Observational Study of the Perfusion Index an a Predictor of Return of Spontaneus Circulation in Out of Hospital Cardiac Arrest
The purpose of this pilot feasibility study is to evaluate the ability of the Perfusion Index to predict the return to spontaneous circulation of the out-of-hospital cardiac arrest patient during cardiopulmonary resuscitation.
The performance of the perfusion index will also be compared to the current gold standard, end-tidal CO2 (EtCO2).
Read the detailed description
The aim of this observational research is to measure the predictive performance the perfusion index to predict a return of a spontaneous circulation (ROSC) during cardiopulmonary resuscitation (CPR).
The research focuses on patients in out-of-hospital cardiac arrest (OHCA) and in-hospital cardiac arrest (IHCA) treated by the mobile intensive care unit of Saint Pierre University Hospital.
The study will be a pilot observational study during cardiac arrest. During the study period a non-invasive sensor will be connected to the patient's finger to measure continously and non-invasively the perfusion index. This non-invasive measurement is done by means of an infrared light which has no known risks for the health of the patient and which is usually used for the measurement of arterial oxygen saturation (SatO2). No intervention is planned as no decision will be taken on treatment based on the collected values of perfusion index during the arrest and post-arrest care of the participants.
The study will therefore be conducted during conventional advanced life support procedures without rescuers having access to the ongoing measurements.
The study will end when the participant returns to spontaneous circulation (RACS) or when patients is admitted to the emergency ward, whichever comes first in a time frame of maximum two hours.
The decision to stop resuscitation procedures will be made in accordance with the European Resuscitation Council (ERC) recommendations and the Resuscitation Termination Rules (TOR) for cardiac arrest.
Pulsatility index values will be sampled at a 0.5 Hertz frequency. These values will be tested for their ability to predict ROSC within 2 minutes. Similarly, EtCO2 values (as a gold standard) will be analyzed from the time of first measure. The sensitivity and specificity of the collected values of EtCO2 in the prediction of ROSC will be compared, at the end of the study to the diagnostic sensibility and specificity of different thresholds of the perfusion index.
The patient's consent will be requested at the moment when he/she recovers consciousness allowing the comprehension and signature of a consent after the cardiac arrest.
- Keywords
- cardiac arrest, perfusion index, Return of spontaneous circulation, End tidal CO2
- Medical subject headings
- Death, Sudden, Cardiac, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observational cohort | The study is an observational study on a single cohort of consecutive out-of-hospital cardiac arrest patients. All patients in the cohort will be monitored with a non-invasive pletismograph. No intervention will be administered to any patient and no decision on treatment will be based on the collected informations. Treating physicians will be blinded to collected values of perfusion index during the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return of Spontaneous Circulation - Perfusion index - absolute values
Receiver operating characteristic curve of the perfusion index to predict return of spontaneous circulation. Area under the curve of the receiver operating curve will be measured and reported for absolute values.
Measured: From study inclusion until hospital admission or date of death from any cause, whichever came first, assessed up to 2 hours after inclusion
Return of Spontaneous Circulation - Perfusion index - trend values
Receiver operating characteristic curve of the perfusion index to predict return of spontaneous circulation. Area under the curve of the receiver operating curve will be measured and reported for trend values of the pulsatility index.
Measured: From study inclusion until hospital admission or date of death from any cause, whichever came first, assessed up to 2 hours after inclusion
Secondary outcomes (1)
Return of Spontaneous Circulation - EtCO2 - Perfusion index
A receiver operating characteristic curve of the perfusion index to predict return of spontaneous circulation will be plotted against a receiver operating characteristic curve of end-tidal CO2 to predict return of spontaneous circulation. Area under the curve of the two receiver operating curve will be compared and assessed for superiority.
Measured: From study inclusion until hospital admission or date of death from any cause, whichever came first, assessed up to 2 hours after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start1 Jan 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Death, Sudden, CardiacStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05383885
- Sponsor's protocol ID
- CE/21-11-01
- Status last verified
- May 2022
- First submitted
- 3 May 2022
- Last updated
- 21 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be available to other researcher as csv excell file one month after publication
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study of the Perfusion Index an a Predictor of Return of Spontaneus Circulation in Out of Hospital Cardiac Arrest
- ClinicalTrials.gov ID
- NCT05383885
- Acronym / sponsor ID
- CE/21-11-01
- Keywords
- cardiac arrest, perfusion index, Return of spontaneous circulation, End tidal CO2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire Saint PierreUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 20 May 2022 (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 purpose of this pilot feasibility study is to evaluate the ability of the Perfusion Index to predict the return to spontaneous circulation of the out-of-hospital cardiac arrest patient during cardiopulmonary resuscitation.
The performance of the perfusion index will also be compared to the current gold standard, end-tidal CO2 (EtCO2).
Detailed description
The aim of this observational research is to measure the predictive performance the perfusion index to predict a return of a spontaneous circulation (ROSC) during cardiopulmonary resuscitation (CPR).
The research focuses on patients in out-of-hospital cardiac arrest (OHCA) and in-hospital cardiac arrest (IHCA) treated by the mobile intensive care unit of Saint Pierre University Hospital.
The study will be a pilot observational study during cardiac arrest. During the study period a non-invasive sensor will be connected to the patient's finger to measure continously and non-invasively the perfusion index. This non-invasive measurement is done by means of an infrared light which has no known risks for the health of the patient and which is usually used for the measurement of arterial oxygen saturation (SatO2). No intervention is planned as no decision will be taken on treatment based on the collected values of perfusion index during the arrest and post-arrest care of the participants.
The study will therefore be conducted during conventional advanced life support procedures without rescuers having access to the ongoing measurements.
The study will end when the participant returns to spontaneous circulation (RACS) or when patients is admitted to the emergency ward, whichever comes first in a time frame of maximum two hours.
The decision to stop resuscitation procedures will be made in accordance with the European Resuscitation Council (ERC) recommendations and the Resuscitation Termination Rules (TOR) for cardiac arrest.
Pulsatility index values will be sampled at a 0.5 Hertz frequency. These values will be tested for their ability to predict ROSC within 2 minutes. Similarly, EtCO2 values (as a gold standard) will be analyzed from the time of first measure. The sensitivity and specificity of the collected values of EtCO2 in the prediction of ROSC will be compared, at the end of the study to the diagnostic sensibility and specificity of different thresholds of the perfusion index.
The patient's consent will be requested at the moment when he/she recovers consciousness allowing the comprehension and signature of a consent after the cardiac arrest.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational cohort | – | –The study is an observational study on a single cohort of consecutive out-of-hospital cardiac arrest patients. All patients in the cohort will be monitored with a non-invasive pletismograph. No intervention will be administered to any patient and no decision on treatment will be based on the collected informations. Treating physicians will be blinded to collected values of perfusion index during the study |
Who may qualify
- Ages
- 12 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient with out-of-hospital or in-hospital cardiac arrest will be assessed for eligibility. After verifiying inclusion and exclusion criteria patients will be included in the study.
Key inclusion criteria (2 listed)
- Out of hospital cardiac arrest with an indication to initiate chest compressions
- In hospital cardiac arrest with an indication to initiate chest compressions
Key exclusion criteria (2 listed)
- Pregnant patients
- Prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Return of Spontaneous Circulation - Perfusion index - absolute values
Time frame: From study inclusion until hospital admission or date of death from any cause, whichever came first, assessed up to 2 hours after inclusion
Receiver operating characteristic curve of the perfusion index to predict return of spontaneous circulation. Area under the curve of the receiver operating curve will be measured and reported for absolute values.
Return of Spontaneous Circulation - Perfusion index - trend values
Time frame: From study inclusion until hospital admission or date of death from any cause, whichever came first, assessed up to 2 hours after inclusion
Receiver operating characteristic curve of the perfusion index to predict return of spontaneous circulation. Area under the curve of the receiver operating curve will be measured and reported for trend values of the pulsatility index.
1 secondary outcome
Return of Spontaneous Circulation - EtCO2 - Perfusion index
Time frame: From study inclusion until hospital admission or date of death from any cause, whichever came first, assessed up to 2 hours after inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
- Individual participant dataSharing planned: Yes. Individual participant data will be available to other researcher as csv excell file one month after publication
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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.
Diane De Longueville, MD contact
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 Death, Sudden, Cardiac and Perfusion Index, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
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: status not confirmed, as of the sponsor's last update on 21 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 Belgium. 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 Stefano Malinverni, MD, Ph.D (+32471268267, stefano.malinverni@stpierre-bru.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Return of Spontaneous Circulation - Perfusion index - absolute values (time frame: From study inclusion until hospital admission or date of death from any cause, whichever came first, assessed up to 2 hours after inclusion). The study lists 2 primary outcomes in all. 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 21 Mar 2023.