Perfusion IndexNCT06998849
The Impact of Intraoperative Change in the Body Temperature on the Perfusion Index
An observational study of Perfusion Index and Hypothermia; Anesthesia, run by Ain Shams University at 1 site in Egypt.
Trial summary
The goal of this observational study is to learn about the impact of intraoperative change in temperature in adult patients undergoing surgeries under general anaesthesia. The main question it aims to answer is: Is the change in core body temperature reflected by changes in the prfusion index? Patients' core… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Perfusion Index, Hypothermia; Anesthesia
- What is being tested?
- Perfusion index
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2024to 5 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing elective surgery under general anesthesia in the months between April 2024 and June 2024 at Ain Shams University Hospitals
Who may be able to join
- Patients undergoing elective surgery under general anaesthesia
- Patients aged between 20 and 70 years old.
Who cannot join
- Patients who decline to give a written informed consent.
- Patients with psychiatric disorders that lead to inability to cooperate, speak, or read.
- BMI between <20 kg/m2 or >35 kg/m2.
- Patients undergoing emergency surgeries.
- Patients with peripheral vascular disease or rheumatoid disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Intraoperative Change in the Body Temperature on the Perfusion Index: : A Cross-sectional Study
The goal of this observational study is to learn about the impact of intraoperative change in temperature in adult patients undergoing surgeries under general anaesthesia. The main question it aims to answer is:
Is the change in core body temperature reflected by changes in the prfusion index? Patients' core temperature, peripheral temperature and perfusion indices will be recorded throughout the span of the procedure.
Read the detailed description
Perioperative hypothermia increases the risk of postoperative morbidity and mortality. Almost 50-90% of the patients experience perioperative hypothermia. This involves a decrease in core temperature to ≤ 36°C, which results in an increased rate of surgical site infection, haemorrhagic tendency, and ischemic heart disease, making it a serious perioperative complication.
Early hypothermia during general anaesthesia is mainly caused by the redistribution of body heat from the central to peripheral compartments, due to vasodilation following use of the anaesthetics. The degree of redistribution of body heat may be affected by the peripheral perfusion state, which differs across patients and results in a difference in gradient between temperature of the central and peripheral compartments. Low peripheral perfusion state can lead to low peripheral body temperature, thus lowering the overall core body temperature.
It was previously reported that the risk factors for intraoperative hypothermia are age, BMI, preoperative systolic blood pressure, heart rate, baseline core temperature, ASA-PS score, the type of anaesthesia and surgery, the duration of preparation and surgery, and ambient temperature.
Previous studies did not include the PI as a risk factor for intraoperative hypothermia. Therefore, further studies are needed to assess the relationship between PI and hypothermia to generate a more accurate predictive score of perioperative hypothermia.
- Conditions
- Perfusion Index, Hypothermia; Anesthesia
- Being tested
- Perfusion index
- Keywords
- Cross sectional, Observational, Hypothermia, Anaesthesia, Anesthesia, General Anaesthesia, General Anesthesia, General surgery
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perfusion indexDiagnostic test
The perfusion index (PI) is defined as the ratio of pulsatile light absorption to continuous light absorption, denoted as AC/DC. Initially used as a quality signal indicator in pulse oximetry, PI has increasingly been recognized for its potential in non-invasive hemodynamic monitoring. Since PI changes with peripheral blood flow, it may reflect peripheral temperature gradients and, consequently, thermoregulatory responses like peripheral vasoconstriction. Studies have reported that the core-to-peripheral temperature difference correlates with peripheral PI. The findings suggest that both peripheral and core temperatures contribute to the threshold for shivering and that PI reflects the vasoconstriction induced by thermoregulatory responses that precede shivering
| Study group | Role | What they receive |
|---|---|---|
| Adult patients undergoing general surgery | Adult patients undergoing elective general surgery Receives: Diagnostic Test: Perfusion index |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the change of PI associated with change in core and peripheral body temperatures as measured by the oropharyngeal probe and the pattern of this change
The PI was recorded by attaching a sensor to the patient's finger (Ultralife Pulse Oximeter JPD-500D). The baseline body temperature (T1) was measured using a Granzia GT-3 Digital thermometer. Subsequently, the PI was recorded and assessed every 15 min until completion of the surgery.
Measured: Through study completion, 3 months from April 2024 to June 2024
Secondary outcomes (2)
To detect the change of PI with the change in temperature gradient (it is defined as the difference between the skin temperature and the core temperature)
Measured: Through study completion, 3 months from April 2024 to June 2024
To detect the incidence of a low reading of PI and the increase in serum lactate level in an arterial blood gases sample.
A baseline ABG (B1) was drawn, and serum lactate value was recorded. A follow up ABG (B2) was drawn at PI values <0.2%, and serum lactate was recorded again.
Measured: Through study completion, 3 months from April 2024 to June 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start1 Apr 2024
- Primary completion30 Jun 2024
- Study completion5 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perfusion IndexStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06998849
- Sponsor's protocol ID
- MS143/2024
- Status last verified
- Apr 2024
- First submitted
- 4 Apr 2025
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Intraoperative Change in the Body Temperature on the Perfusion Index: : A Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06998849
- Acronym / sponsor ID
- MS143/2024
- Conditions
- Perfusion Index, Hypothermia; Anesthesia
- Keywords
- Cross sectional, Observational, Hypothermia, Anaesthesia, Anesthesia, General Anaesthesia, General Anesthesia, General surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 5 Aug 2024 (actual)
- First posted
- 31 May 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.
The goal of this observational study is to learn about the impact of intraoperative change in temperature in adult patients undergoing surgeries under general anaesthesia. The main question it aims to answer is:
Is the change in core body temperature reflected by changes in the prfusion index? Patients' core temperature, peripheral temperature and perfusion indices will be recorded throughout the span of the procedure.
Detailed description
Perioperative hypothermia increases the risk of postoperative morbidity and mortality. Almost 50-90% of the patients experience perioperative hypothermia. This involves a decrease in core temperature to ≤ 36°C, which results in an increased rate of surgical site infection, haemorrhagic tendency, and ischemic heart disease, making it a serious perioperative complication.
Early hypothermia during general anaesthesia is mainly caused by the redistribution of body heat from the central to peripheral compartments, due to vasodilation following use of the anaesthetics. The degree of redistribution of body heat may be affected by the peripheral perfusion state, which differs across patients and results in a difference in gradient between temperature of the central and peripheral compartments. Low peripheral perfusion state can lead to low peripheral body temperature, thus lowering the overall core body temperature.
It was previously reported that the risk factors for intraoperative hypothermia are age, BMI, preoperative systolic blood pressure, heart rate, baseline core temperature, ASA-PS score, the type of anaesthesia and surgery, the duration of preparation and surgery, and ambient temperature.
Previous studies did not include the PI as a risk factor for intraoperative hypothermia. Therefore, further studies are needed to assess the relationship between PI and hypothermia to generate a more accurate predictive score of perioperative hypothermia.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients undergoing general surgery | – | Diagnostic Test: Perfusion indexAdult patients undergoing elective general surgery |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective surgery under general anesthesia in the months between April 2024 and June 2024 at Ain Shams University Hospitals
Key inclusion criteria (2 listed)
- Patients undergoing elective surgery under general anaesthesia
- Patients aged between 20 and 70 years old.
Key exclusion criteria (5 listed)
- Patients who decline to give a written informed consent.
- Patients with psychiatric disorders that lead to inability to cooperate, speak, or read.
- BMI between <20 kg/m2 or >35 kg/m2.
- Patients undergoing emergency surgeries.
- Patients with peripheral vascular disease or rheumatoid disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perfusion indexThe perfusion index (PI) is defined as the ratio of pulsatile light absorption to continuous light absorption, denoted as AC/DC. Initially used as a quality signal indicator in pulse oximetry, PI has increasingly been recognized for its potential in non-invasive hemodynamic monitoring. Since PI changes with peripheral blood flow, it may reflect peripheral temperature gradients and, consequently, thermoregulatory responses like peripheral vasoconstriction. Studies have reported that the core-to-peripheral temperature difference correlates with peripheral PI. The findings suggest that both peripheral and core temperatures contribute to the threshold for shivering and that PI reflects the vasoconstriction induced by thermoregulatory responses that precede shivering | Diagnostic test | Adult patients undergoing general surgery |
Primary outcome
To measure the change of PI associated with change in core and peripheral body temperatures as measured by the oropharyngeal probe and the pattern of this change
Time frame: Through study completion, 3 months from April 2024 to June 2024
The PI was recorded by attaching a sensor to the patient's finger (Ultralife Pulse Oximeter JPD-500D). The baseline body temperature (T1) was measured using a Granzia GT-3 Digital thermometer. Subsequently, the PI was recorded and assessed every 15 min until completion of the surgery.
2 secondary outcomes
To detect the change of PI with the change in temperature gradient (it is defined as the difference between the skin temperature and the core temperature)
Time frame: Through study completion, 3 months from April 2024 to June 2024
To detect the incidence of a low reading of PI and the increase in serum lactate level in an arterial blood gases sample.
Time frame: Through study completion, 3 months from April 2024 to June 2024
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Perfusion Index and Hypothermia; Anesthesia, 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 5 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: finished, as of the sponsor's last update on 31 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To measure the change of PI associated with change in core and peripheral body temperatures as measured by the oropharyngeal probe and the pattern of this change (time frame: Through study completion, 3 months from April 2024 to June 2024). 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 31 May 2025.