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

Sponsor
National Hepatology & Tropical Medicine Research Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT06067464
Collaborator
(none)
47
Enrollment
1
Location
16.3
Anticipated Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    47 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of Peripheral Pulse-oximeter Derived Perfusion Index as a Prognostication Tool for High Quality Cardiopulmonary Resuscitation and Return of Spontaneous Circulation
    Actual Study Start Date :
    Aug 23, 2023
    Anticipated Primary Completion Date :
    Sep 1, 2024
    Anticipated Study Completion Date :
    Jan 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. prognostication [during 20 minutes of CPR]

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

    Secondary Outcome Measures

    1. prognostication [during20 minutes of CPR]

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

    2. survival [one week and 30 days]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:
    • 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 .

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 NHTMRI Cairo Egypt 4260010

    Sponsors and Collaborators

    • National Hepatology & Tropical Medicine Research Institute

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ICU, fellow of intensive care medicine, National Hepatology & Tropical Medicine Research Institute
    ClinicalTrials.gov Identifier:
    NCT06067464
    Other Study ID Numbers:
    • 28-2023
    First Posted:
    Oct 4, 2023
    Last Update Posted:
    Oct 4, 2023
    Last Verified:
    Sep 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Heart Arrest

    Study Results

    No Results Posted as of Oct 4, 2023