Comparison Between Perfusion Index and Pulse Pressure Variability for Prediction of Intravascular Volume During Major Abdominal SurgeriesNCT07024108
Comparison Between Perfusion Index and Pulse Pressure Variability for Prediction of Intravascular Volume During Major Abdominal Surgeries
An observational study of Comparison Between Perfusion Index and Pulse Pressure Variability for Prediction of Intravascular Volume During Major Abdominal Surgeries, run by Ain Shams University at 1 site in Egypt.
Trial summary
Each year, at least 310 million patients undergo major surgery worldwide, procedures that involve the administration of intravenous fluids Intraoperative hemodynamic management is challenging because precise assessment of the adequacy of the intravascular volume is difficult during surgery Achieving optimal IV fluid… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Comparison Between Perfusion Index and Pulse Pressure Variability for Prediction of Intravascular Volume During Major Abdominal Surgeries
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Feb 2025to 30 Aug 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study population: adult patients under general anaesthesia scheduled for major abdominal surgeries between the period from January 2025 to june 2025 will be observed for comparison between PI and PPV in detecting intravascular volume.
Who may be able to join
- -
- ASA 1, 2 Age: 18-65 Undergoing major abdominal surgeries Mechanically ventilated and sedated patients
Who cannot join
- 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
- -
Trial locations and contacts
1 site in 1 country.
About this study
Each year, at least 310 million patients undergo major surgery worldwide, procedures that involve the administration of intravenous fluids Intraoperative hemodynamic management is challenging because precise assessment of the adequacy of the intravascular volume is difficult during surgery Achieving optimal IV fluid therapy should improve perioperative outcomes and is a key component in many perioperative guidelines and pathways. IV fluids, like other medications, should only be given in well-defined protocols according to individual needs More recently, so called dynamic predictors of fluid responsiveness such as pulse pressure variation (PPV), stroke volume variation (SVV), or Perfusion Index (PI) have been used in intraoperative goal directed fluid therapy ( GDT) hemodynamic protocols
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between perfusion index and pulse pressure variability for prediction of intravascular volume during major abdominal surgeries
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start3 Feb 2025
- Primary completion3 Aug 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Comparison Between Perfusion Index and Pulse Pressure Variability for Prediction of Intravascular Volume During Major Abdominal SurgeriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Randa Ali Shokry, Study chair, Faculty of medicine AinShamsU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07024108
- Sponsor's protocol ID
- FMASU MS 73/2025
- Status last verified
- Feb 2025
- First submitted
- 26 Apr 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Perfusion Index and Pulse Pressure Variability for Prediction of Intravascular Volume During Major Abdominal Surgeries
- ClinicalTrials.gov ID
- NCT07024108
- Acronym / sponsor ID
- FMASU MS 73/2025
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 3 Aug 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 17 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Each year, at least 310 million patients undergo major surgery worldwide, procedures that involve the administration of intravenous fluids Intraoperative hemodynamic management is challenging because precise assessment of the adequacy of the intravascular volume is difficult during surgery Achieving optimal IV fluid therapy should improve perioperative outcomes and is a key component in many perioperative guidelines and pathways. IV fluids, like other medications, should only be given in well-defined protocols according to individual needs More recently, so called dynamic predictors of fluid responsiveness such as pulse pressure variation (PPV), stroke volume variation (SVV), or Perfusion Index (PI) have been used in intraoperative goal directed fluid therapy ( GDT) hemodynamic protocols
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- adult patients under general anaesthesia scheduled for major abdominal surgeries between the period from January 2025 to june 2025 will be observed for comparison between PI and PPV in detecting intravascular volume.
Key inclusion criteria (2 listed)
- -
- ASA 1, 2 Age: 18-65 Undergoing major abdominal surgeries Mechanically ventilated and sedated patients
Key exclusion criteria (2 listed)
- 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
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Randa Ali Shokry study chair
Faculty of medicine AinShamsU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Comparison Between Perfusion Index and Pulse Pressure Variability for Prediction of Intravascular Volume During Major Abdominal Surgeries, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison between perfusion index and pulse pressure variability for prediction of intravascular volume during major abdominal surgeries (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.