Ignite Creation Date:
2024-05-06 @ 7:36 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06067464
Status:
RECRUITING
Last Update Posted:
2023-10-04
First Post:
2023-08-28
Brief Title:
Evaluation of Perfusion Index as a Prognostication Tool for High Quality Cardiopulmonary Resuscitation
Sponsor:
National Hepatology Tropical Medicine Research Institute
Organization:
National Hepatology Tropical Medicine Research Institute
Study Overview
Official Title:
Evaluation of Peripheral Pulse-oximeter Derived Perfusion Index as a Prognostication Tool for High Quality Cardiopulmonary Resuscitation and Return of Spontaneous Circulation
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In order to monitor and improve cardiopulmonary resuscitationCPR 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 2-25KPa 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 compressionCC during cardiopulmonary resuscitationCPR
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 percentagePI ACIRDCIR100 ie 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 002 very weak to 20 strongPeripheral 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
High quality chest compression will result inETCO2 between 2-25KPa 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 compressionCC during cardiopulmonary resuscitationCPR
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 percentagePI ACIRDCIR100 ie 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 002 very weak to 20 strongPeripheral 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 CommitteeAll demographic data will be obtained including the patients age sex associated co-morbidities eg 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 20211 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 CPRThe medical staff did not alter the patients treatment based on PI results One week and 30 day survival will be followed
Resuscitation for patients will be held according to ERC Advanced life support ALS Algorithm 20211 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 CPRThe medical staff did not alter the patients treatment based on PI results One week and 30 day survival will be followed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None