Cardiac ArrestNCT06067464
Evaluation of Perfusion Index as a Prognostication Tool for High Quality Cardiopulmonary Resuscitation
An observational study of Cardiac Arrest, run by National Hepatology & Tropical Medicine Research Institute at 1 site in Egypt.
Trial summary
In order to monitor and improve cardiopulmonary resuscitation(CPR) quality, there is need for tools that provide real time feedback to responders. The use of invasive arterial pressure monitoring and end tidal carbon dioxide (ETCO2) as quality measures of CPR. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cardiac Arrest
- How many people
- 47 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Aug 2023to Jan 2025
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Resuscitation for patients will be held according to ERC (Advanced life support) ALS Algorithm 2021.1 Electrocardiogram of manual defibrillator, pulse oximeter (Nihon-Kohden, Mindray) will be attached to the middle finger or thumb7 and the capnography will be attached between endotracheal tube and Bag mask valve. Both readings of the ETCO2 and pulse oximeter derived perfusion index will be recorded every minute till the end of CPR.The medical staff did not alter the patient's treatment based on PI results. One week and 30 day survival will be followed.
Who may be able to join
- The subjects are adults aged between 18 \& 75years who developed in-hospital cardiac arrest and cardiopulmonary resuscitation for at least 3 minutes either in emergency departments or wards or Intensive care units in the National Hepatology and Tropical Medicine Research Institute (NHTMRI) and Alexandria University
Who cannot join
- Patients will be excluded from the study ifpregnant,known peripheral vascular disease or >2 vasopressors with the maximum doses or in the presence of nail polish as readings from pulse oximeter will be distorted .
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
NHTMRI
Cairo, 4260010
Eman Ibrahim El-Desoki Mahmoud, MD, +201227409501, eman18350@gmail.com
About this study
Official title: Evaluation of Peripheral Pulse-oximeter Derived Perfusion Index as a Prognostication Tool for High Quality Cardiopulmonary Resuscitation and Return of Spontaneous Circulation
In order to monitor and improve cardiopulmonary resuscitation(CPR) quality, there is need for tools that provide real time feedback to responders. The use of invasive arterial pressure monitoring and end tidal carbon dioxide (ETCO2) as quality measures of CPR. Invasive pressure measurements are timeconsuming and cumbersome in resuscitation situations, and are very rarely practical. ETCO2 measurements require presence of a capnometer with an advanced airway.
High quality chest compression will result inETCO2 between 2-2.5KPa. A rapid increase in ETCO2 on waveform capnography may enable ROSC to be detected while continuing chest compression and can be used as a tool to withhold the next dose of bolus adrenaline injection.
Read more
Pulse oximetry, which noninvasively detects the blood flow of peripheral tissue, has achieved widespread clinical use. It was noticed that the pulse waveform frequency can reflect the rate and interruption time of chest compression(CC) during cardiopulmonary resuscitation(CPR).
The perfusion index (PI) is obtained from pulse oximetry and is computed as the ratio of the pulsatile (alternating current) signal to the non-pulsatile (direct current) signal of infra-red light, expressed as a percentage;PI =ACIR/DCIR∗100% (i.e. AC = pulsatile component of the signal, DC = non-pulsatile component of the signal, IR = infrared light).
PI shows the perfusion status of the tissue in the applied area for an instant and a certain time interval. The PI value ranges from 0.02% (very weak) to 20% (strong).Peripheral PI has been proposed for different clinical uses with some applications in critical patients.
The purpose of this study is to evaluate the role of pulse-oximeter derived perfusion index for high quality CPR and as aprognostication tool of ROSC during in-hospital cardiac arrest in comparison to ETCO2 reading.
Read the detailed description
After approval by NHTMRI-IRB Ethical Committee.All demographic data will be obtained including the patients' age, sex, associated co-morbidities (e.g. diabetes mellitus \& hypertension), cause of cardiac arrest, and duration of CPR.
Resuscitation for patients will be held according to ERC (Advanced life support) ALS Algorithm 2021.1 Electrocardiogram of manual defibrillator, pulse oximeter (Nihon-Kohden, Mindray) will be attached to the middle finger or thumb7 and the capnography will be attached between endotracheal tube and Bag mask valve. Both readings of the ETCO2 and pulse oximeter derived perfusion index will be recorded every minute till the end of CPR.The medical staff did not alter the patient's treatment based on PI results. One week and 30 day survival will be followed.
- Conditions
- Cardiac Arrest
- Medical subject headings
- Heart Arrest
What is being measured
The primary outcome is the main question the study is designed to answer.
prognostication
evaluate the role of PI as a prognostic tool for high quality CPR in comparison with ETCO2.
Measured: during 20 minutes of CPR
Secondary outcomes (2)
prognostication
of PI as a prognostication tool for ROSCin comparison to the readings of ETCO2
Measured: during20 minutes of CPR
survival
either higher PI during CPR associated with one week and 30 day survival
Measured: one week and 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start23 Aug 2023
- Primary completionSep 2024 (estimated)
- Study completionJan 2025 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Hepatology & Tropical Medicine Research Institute
- Sponsor type
- Other government
- Responsible party
- Principal investigator, ICU, National Hepatology & Tropical Medicine Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06067464
- Sponsor's protocol ID
- 28-2023
- Status last verified
- Sep 2023
- First submitted
- 28 Aug 2023
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Peripheral Pulse-oximeter Derived Perfusion Index as a Prognostication Tool for High Quality Cardiopulmonary Resuscitation and Return of Spontaneous Circulation
- ClinicalTrials.gov ID
- NCT06067464
- Acronym / sponsor ID
- 28-2023
- Conditions
- Cardiac Arrest
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- National Hepatology & Tropical Medicine Research InstituteOther government
- Study start
- 23 Aug 2023 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 4 Oct 2023 (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.
In order to monitor and improve cardiopulmonary resuscitation(CPR) quality, there is need for tools that provide real time feedback to responders. The use of invasive arterial pressure monitoring and end tidal carbon dioxide (ETCO2) as quality measures of CPR. Invasive pressure measurements are timeconsuming and cumbersome in resuscitation situations, and are very rarely practical. ETCO2 measurements require presence of a capnometer with an advanced airway.
High quality chest compression will result inETCO2 between 2-2.5KPa. A rapid increase in ETCO2 on waveform capnography may enable ROSC to be detected while continuing chest compression and can be used as a tool to withhold the next dose of bolus adrenaline injection.
Pulse oximetry, which noninvasively detects the blood flow of peripheral tissue, has achieved widespread clinical use. It was noticed that the pulse waveform frequency can reflect the rate and interruption time of chest compression(CC) during cardiopulmonary resuscitation(CPR).
The perfusion index (PI) is obtained from pulse oximetry and is computed as the ratio of the pulsatile (alternating current) signal to the non-pulsatile (direct current) signal of infra-red light, expressed as a percentage;PI =ACIR/DCIR∗100% (i.e. AC = pulsatile component of the signal, DC = non-pulsatile component of the signal, IR = infrared light).
PI shows the perfusion status of the tissue in the applied area for an instant and a certain time interval. The PI value ranges from 0.02% (very weak) to 20% (strong).Peripheral PI has been proposed for different clinical uses with some applications in critical patients.
The purpose of this study is to evaluate the role of pulse-oximeter derived perfusion index for high quality CPR and as aprognostication tool of ROSC during in-hospital cardiac arrest in comparison to ETCO2 reading.
Detailed description
After approval by NHTMRI-IRB Ethical Committee.All demographic data will be obtained including the patients' age, sex, associated co-morbidities (e.g. diabetes mellitus \& hypertension), cause of cardiac arrest, and duration of CPR.
Resuscitation for patients will be held according to ERC (Advanced life support) ALS Algorithm 2021.1 Electrocardiogram of manual defibrillator, pulse oximeter (Nihon-Kohden, Mindray) will be attached to the middle finger or thumb7 and the capnography will be attached between endotracheal tube and Bag mask valve. Both readings of the ETCO2 and pulse oximeter derived perfusion index will be recorded every minute till the end of CPR.The medical staff did not alter the patient's treatment based on PI results. One week and 30 day survival will be followed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Resuscitation for patients will be held according to ERC (Advanced life support) ALS Algorithm 2021.1 Electrocardiogram of manual defibrillator, pulse oximeter (Nihon-Kohden, Mindray) will be attached to the middle finger or thumb7 and the capnography will be attached between endotracheal tube and Bag mask valve. Both readings of the ETCO2 and pulse oximeter derived perfusion index will be recorded every minute till the end of CPR.The medical staff did not alter the patient's treatment based on PI results. One week and 30 day survival will be followed.
Key inclusion criteria (1 listed)
- The subjects are adults aged between 18 \& 75years who developed in-hospital cardiac arrest and cardiopulmonary resuscitation for at least 3 minutes either in emergency departments or wards or Intensive care units in the National Hepatology and Tropical Medicine Research Institute (NHTMRI) and Alexandria University
Key exclusion criteria (1 listed)
- Patients will be excluded from the study ifpregnant,known peripheral vascular disease or >2 vasopressors with the maximum doses or in the presence of nail polish as readings from pulse oximeter will be distorted .
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
prognostication
Time frame: during 20 minutes of CPR
evaluate the role of PI as a prognostic tool for high quality CPR in comparison with ETCO2.
2 secondary outcomes
prognostication
Time frame: during20 minutes of CPR
survival
Time frame: one week and 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
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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.
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, run by National Hepatology & Tropical Medicine Research Institute at 1 site in Egypt.
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 1 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 4 Oct 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 Egypt. 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 Eman Ibrahim El-Desoki Mahmoud, MD (+201227409501, eman18350@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prognostication (time frame: during 20 minutes of CPR). 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 4 Oct 2023.