The Impact of Intraoperative Change in the Body Temperature on the Perfusion Index

NCT06998849 | Completed

• 1 other identifier: MS143/2024
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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 temperature, peripheral temperature and perfusion indices will be recorded throughout the span of the procedure.

Conditions

Perfusion Index; Hypothermia; Anesthesia

Keywords

Cross sectional; Observational; Hypothermia; Anaesthesia; Anesthesia; General Anaesthesia; General Anesthesia; General surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  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.

  Through study completion, 3 months from April 2024 to June 2024

Study Arms (1)

Adult patients undergoing general surgery

Adult patients undergoing elective general surgery

Diagnostic Test: Perfusion index

Interventions

Perfusion index DIAGNOSTIC_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

Adult patients undergoing general surgery

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing elective surgery under general anesthesia in the months between April 2024 and June 2024 at Ain Shams University Hospitals

You may qualify if:

• Patients undergoing elective surgery under general anaesthesia
• Patients aged between 20 and 70 years old.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Abbassia, 00202, Egypt

Location

MeSH Terms

Conditions

Hypothermia

Interventions

Perfusion Index

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: May 31, 2025
• Study Start: April 1, 2024
• Primary Completion: June 30, 2024
• Study Completion: August 5, 2024
• Last Updated: May 31, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)