ClinicalTrials.gg
RecruitingNCT06067464Updated Oct 4, 2023

Evaluation of Perfusion Index as a Prognostication Tool for High Quality Cardiopulmonary Resuscitation

An observational study in Cardiac Arrest, sponsored by National Hepatology & Tropical Medicine Research Institute. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-10-04.

Sponsored by National Hepatology & Tropical Medicine Research Institute · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2024, 2 years 2 months ago, but the record still lists the study as recruiting.
  • Started Aug 2023; still recruiting 3 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
47
Ages
18 Years to 75 Years
Sex
All
01

Study 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. 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.

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.

02

Conditions studied

  • Cardiac Arrest

Browse trials for

03

In context

Heart Arrest

926 studies on the registry are indexed under Heart Arrest; 226 are open to participants now.

This study's planned enrollment of 47 is below the median of 200 across 376 observational studies indexed under Heart Arrest.

Browse Heart Arrest studies →

Lead sponsor

National Hepatology & Tropical Medicine Research Institute is the lead sponsor of 20 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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 .
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
47 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. prognostication

    evaluate the role of PI as a prognostic tool for high quality CPR in comparison with ETCO2.

    Time frame: during 20 minutes of CPR

Secondary outcomes

  1. prognostication

    of PI as a prognostication tool for ROSCin comparison to the readings of ETCO2

    Time frame: during20 minutes of CPR

  2. survival

    either higher PI during CPR associated with one week and 30 day survival

    Time frame: one week and 30 days

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2023 (actual). Primary completion is estimated for Sep 2024, 13 months after the start.

Of 169 non-industry observational studies under Heart Arrest, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 90. This study's planned 13 months is below that.

Counting every sponsor, half of 176 studies reached it within 41 months; a quarter within 18 and three quarters within 90.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 28, 2023
First posted
Oct 4, 2023
StartActual
Aug 23, 2023
Primary completionEst.
Sep 2024
CompletionEst.
Jan 2025
Last update
Oct 4, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 4, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06067464
Lead sponsor
National Hepatology & Tropical Medicine Research Institute
Responsible party
ICU (fellow of intensive care medicine, National Hepatology & Tropical Medicine Research Institute) — Principal investigator
First posted
Oct 4, 2023
Start date
Aug 23, 2023
Primary completion
Sep 2024 (estimated)
Completion
Jan 2025 (estimated)
Last update
Oct 4, 2023

Study contacts

Eman Ibrahim El-Desoki Mahmoud, MD
Contact
eman18350@gmail.com
+201227409501

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion