Ignite Creation Date:
2024-05-06 @ 7:35 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06063993
Status:
RECRUITING
Last Update Posted:
2023-10-03
First Post:
2023-08-28
Brief Title:
Evaluation of Perfusion Index Change Post Passive Leg Raising for Fluid Responsiveness in Critically Ill
Sponsor:
National Hepatology Tropical Medicine Research Institute
Organization:
National Hepatology Tropical Medicine Research Institute
Study Overview
Official Title:
Evaluation of Pulse-oximetry Derived Perfusion Index Change Post Passive Leg Raising for Fluid Responsiveness in Critically Ill Patients
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:
Peripheral Perfusion Index PI has been investigated for its use in hemodynamic monitoring The PI is derived from the photoelectric plethysmographic signal of the pulse oximeter The changes in the PI reflect changes in peripheral vasomotor tone
In critically ill patients the same value was found to represent a very sensitive cutoff point for determining abnormal peripheral perfusion as defined by a prolonged Capillary Refill Time CRT However age gender and ambient temperature have all been shown to affect the measure of CRT in normal volunteers and the presence of a CRT 2 or 3 seconds was not predictive of blood loss in phlebotomized volunteers In addition the CRT has been shown to have poor intra-observer agreement when a cutoff a two seconds was used in adult emergency room patients13 Therefore PI can be used for monitoring peripheral perfusion in critically ill patients14PI 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 strong
As non-invasive CO monitors ICON is not available in many centers in our country due to its high cost we try to validate other simple non-invasive method to be used to assess FR in critically ill patients
The purpose of this study is to investigate the efficacy of pulse-oximeter derived PI measurement in assessment of fluid responsiveness in critically ill patients in comparison with CO response
In critically ill patients the same value was found to represent a very sensitive cutoff point for determining abnormal peripheral perfusion as defined by a prolonged Capillary Refill Time CRT However age gender and ambient temperature have all been shown to affect the measure of CRT in normal volunteers and the presence of a CRT 2 or 3 seconds was not predictive of blood loss in phlebotomized volunteers In addition the CRT has been shown to have poor intra-observer agreement when a cutoff a two seconds was used in adult emergency room patients13 Therefore PI can be used for monitoring peripheral perfusion in critically ill patients14PI 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 strong
As non-invasive CO monitors ICON is not available in many centers in our country due to its high cost we try to validate other simple non-invasive method to be used to assess FR in critically ill patients
The purpose of this study is to investigate the efficacy of pulse-oximeter derived PI measurement in assessment of fluid responsiveness in critically ill patients in comparison with CO response
Detailed Description:
After approval by NHTMRI-IRB Ethical CommitteeAll demographic data will be obtained including the patients age sexassociated co-morbidities diabetes mellitus hypertension
Continuous blood pressure continuous electrocardiogram heart rate HR and SpO2 measured by pulse oximetry
Patients who are eligible and have signs of hemodynamic instability PLR will be performed by adjusting the bed and not by manually raising the patients legs Bronchial secretions must be carefully aspirated before PLR If awake the patient should be informed of what the test involvesPLR should start from the semi-recumbent and not the supine position Adding trunk lowering tosupine position and leg raisingfor 45 for 60 seconds this mobilizes venous blood from the large splanchnic compartment thus magnifying the increasing effects of leg elevation on cardiac preload18COand PI measurements will be recorded in the same patients
Continuous blood pressure continuous electrocardiogram heart rate HR and SpO2 measured by pulse oximetry
Patients who are eligible and have signs of hemodynamic instability PLR will be performed by adjusting the bed and not by manually raising the patients legs Bronchial secretions must be carefully aspirated before PLR If awake the patient should be informed of what the test involvesPLR should start from the semi-recumbent and not the supine position Adding trunk lowering tosupine position and leg raisingfor 45 for 60 seconds this mobilizes venous blood from the large splanchnic compartment thus magnifying the increasing effects of leg elevation on cardiac preload18COand PI measurements will be recorded in the same patients
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