- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07024108
- Original Trial
Comparison Between Perfusion Index and Pulse Pressure Variability for Prediction of Intravascular Volume During Major Abdominal Surgeries
Study Overview
Status
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
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Cairo, Egypt, 1111
- Ain Shams University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
-
Inclusion Criteria:
ASA 1, 2 Age: 18-65 Undergoing major abdominal surgeries Mechanically ventilated and sedated patients
Exclusion Criteria:
Chronic cardiac arrhythmias High doses of vasopressors Altered myocardial function (left ventricular ejection fraction < 50%) Peripheral vascular disease Severe respiratory disease Pulmonary or intra-abdominal hypertension Open chest
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison between perfusion index and pulse pressure variability for prediction of intravascular volume during major abdominal surgeries
Time Frame: 6 months
|
Comparing 2 percentage; Perfusion index and pulse pressure variability in assessment of intravascular volume and fluid responsiveness of the patient during major abdominal surgeries PI is a ratio of pulsatile light absorption to continuous light absorption, denoted as AC/DC. Normal PI values can vary widely, ranging from less than 1% to greater than 10%. The pulse pressure variation (PPV) is a percentage measure of the respiratory effect on the variation of systemic arterial blood pressure in patients receiving full mechanical ventilation The PI will be monitored by attaching a sensor to the patient's finger (Ultralife Pulse Oximeter JPD-500D). The PPV will be measured using an arterial line in radial artery Patients will receive maintenance and deficit fluids then measuring perfusion index (PI) and pulse pressure variability (PPV) which the cut off value of is higher than 13% for more than 5 min, values of PI in percentage in corresponding time will be measured and recorded |
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Randa Ali Shokry, Faculty of medicine AinShamsU
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- FMASU MS 73/2025
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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