Rectal Temperature Measurement in Detecting Hypothermia During Hip Arthroscopy

Is Rectal Temperature Measurement Quicker in Detecting Hypothermia During Hip Arthroscopy

Irrigation fluids used during hip arthroscopy surgery are generally stored at room temperature and are cooler than the core temperature of the patient. They are used abundantly during hip arthroscopy surgery. The aim of this study is to detect local and then general hypothermia that may occur by monitoring the body temperature from the rectal mucosa of patients undergoing hip arthroscopy, using irrigation fluids of different temperatures and comparing it with the temperature measured from the temporal region.

Study Overview

• Status: Completed
• Conditions: Hypothermia; Orthopedic Disorder; Hip Arthropathy
• Intervention / Treatment: Procedure: Rectal temperature measurement; Procedure: Temporal temperature measurement

Detailed Description

This is a prospective randomized controlled study where sequential randomization will be applied to patients; The first patient will be included in the 1st group, and the second patient will be included into the 2nd group, and so on. All patients scheduled for hip arthroscopy in our institution during the defined study period are eligible for inclusion. While room temperature irrigation fluids will be used routinely for Group 1, irrigation fluids heated up to 36-38 degrees will be used for the other group. Patients will be operated in the same operating room and at the same room temperature with the same type/amount of covering and body warming. At the start of the surgical procedure, a probe inserted into the rectal mucosa will measure the patient's body temperature every 15 minutes. In addition, the temperature of the patients will be measured from their temporal regions with a contactless thermometer, whose batteries will be changed every two operations. The data obtained will be analyzed by a blinded researcher. Mean body temperatures measured from 2 different locations (temporal region and rectal mucosa) between the groups will be compared, and the probability of detecting early local and later general hypothermia from the rectal mucosa will be examined.

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06800
    • Ankara City Hospital - Ankara Şehir Hastanesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

- Patients between the ages of 18-50 undergoing hip arthroscopy and willing to participate

Exclusion Criteria:

• Patients with a previous history of surgery from the same hip
• Patients with a history of thyroid disease (hypo/hyperthyroidism)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Room Group; Room temperature irrigation fluids will be used routinely for Group 1. Patients will be operated in the same operating room and at the same room temperature with the same type/amount of covering and body warming. At the start of the surgical procedure, a probe inserted into the rectal mucosa will measure the patient's body temperature every 15 minutes. In addition, the temperature of the patients will be measured from their temporal regions with a contactless thermometer, whose batteries will be changed every two operations.	Procedure: Rectal temperature measurement; Patients will be operated in the same operating room and at the same room temperature with the same type/amount of covering and body warming. At the start of the surgical procedure, a probe inserted into the rectal mucosa will measure the patient's body temperature every 15 minutes. In addition, the temperature of the patients will be measured from their temporal regions with a contactless thermometer. The data obtained will be analyzed by a blinded researcher. Mean body temperatures measured from 2 different locations (temporal region and rectal mucosa) between the groups will be compared, and the probability of detecting early local and later general hypothermia from the rectal mucosa will be examined; Procedure: Temporal temperature measurement; Patients will be operated in the same operating room and at the same room temperature with the same type/amount of covering and body warming. At the start of the surgical procedure, a probe inserted into the rectal mucosa will measure the patient's body temperature every 15 minutes. In addition, the temperature of the patients will be measured from their temporal regions with a contactless thermometer. The data obtained will be analyzed by a blinded researcher. Mean body temperatures measured from 2 different locations (temporal region and rectal mucosa) between the groups will be compared, and the probability of detecting early local and later general hypothermia from the rectal mucosa will be examined
Active Comparator: Warmed Group; Irrigation fluids heated up to 36-38 degrees will be used for Group 2.Patients will be operated in the same operating room and at the same room temperature with the same type/amount of covering and body warming. At the start of the surgical procedure, a probe inserted into the rectal mucosa will measure the patient's body temperature every 15 minutes. In addition, the temperature of the patients will be measured from their temporal regions with a contactless thermometer, whose batteries will be changed every two operations.	Procedure: Rectal temperature measurement; Patients will be operated in the same operating room and at the same room temperature with the same type/amount of covering and body warming. At the start of the surgical procedure, a probe inserted into the rectal mucosa will measure the patient's body temperature every 15 minutes. In addition, the temperature of the patients will be measured from their temporal regions with a contactless thermometer. The data obtained will be analyzed by a blinded researcher. Mean body temperatures measured from 2 different locations (temporal region and rectal mucosa) between the groups will be compared, and the probability of detecting early local and later general hypothermia from the rectal mucosa will be examined; Procedure: Temporal temperature measurement; Patients will be operated in the same operating room and at the same room temperature with the same type/amount of covering and body warming. At the start of the surgical procedure, a probe inserted into the rectal mucosa will measure the patient's body temperature every 15 minutes. In addition, the temperature of the patients will be measured from their temporal regions with a contactless thermometer. The data obtained will be analyzed by a blinded researcher. Mean body temperatures measured from 2 different locations (temporal region and rectal mucosa) between the groups will be compared, and the probability of detecting early local and later general hypothermia from the rectal mucosa will be examined

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Is rectal temperature measurement more effective in detecting hypothermia?	Throughout the intervention, every 15 minutes, temperature will be measured from the rectum and from the temporal region. Rectal temperature measurements will be compared to temporal measurements in a standardized environment (OR room temperature, noted every 15 min). Comparison will show whether rectal temperature measurement is superior to temporal measurement in detecting intraoperative hypothermia during hip arthroscopy.	During the intervention, every 15 minutes.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Does the usage of warmed irrigation fluids avoid or delay intraoperative hypothermia during hip arthroscopy?	While room temperature irrigation fluids will be used routinely for Group 1, irrigation fluids heated up to 36-38 degrees will be used for the other group. Patients will be operated in the same operating room and at the same room temperature with the same type/amount of covering and body warming. At the start of the surgical procedure, a probe inserted into the rectal mucosa will measure the patient's body temperature every 15 minutes. In addition, the temperature of the patients will be measured from their temporal regions with a contactless thermometer. The secondary outcome of this study is to investigate whether usage of warmed irrigation fluids avoid or delay intraoperative hypothermia during hip arthroscopy.	During the intervention, every 15 minutes.

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent
• Investigators: Study Director: Kasım Kılıçarslan, MD, Ankara City Hospital Bilkent

Publications and helpful links

General Publications

• Simpson JB, Thomas VS, Ismaily SK, Muradov PI, Noble PC, Incavo SJ. Hypothermia in Total Joint Arthroplasty: A Wake-Up Call. J Arthroplasty. 2018 Apr;33(4):1012-1018. doi: 10.1016/j.arth.2017.10.057. Epub 2017 Nov 8.
• Nordgren M, Hernborg O, Hamberg A, Sandstrom E, Larsson G, Soderstrom L. The Effectiveness of Four Intervention Methods for Preventing Inadvertent Perioperative Hypothermia During Total Knee or Total Hip Arthroplasty. AORN J. 2020 Mar;111(3):303-312. doi: 10.1002/aorn.12961.
• Parodi D, Valderrama J, Tobar C, Besomi J, Lopez J, Lara J, Ilic JP. Effect of warmed irrigation solution on core body temperature during hip arthroscopy for femoroacetabular impingement. Arthroscopy. 2014 Jan;30(1):36-41. doi: 10.1016/j.arthro.2013.08.035. Epub 2013 Oct 30.
• Ukrani RD, Arif A, Sadruddin A, Hasan O, Noordin S. Intraoperative hypothermia in patients undergoing Total knee arthroplasty: a cross-sectional study from a developing country. BMC Musculoskelet Disord. 2021 May 31;22(1):504. doi: 10.1186/s12891-021-04390-7.
• Ohki K, Kawano R, Yoshida M, Kanosue I, Yamamoto K. Normothermia is Best Achieved by Warming Above and Below with Pre-warming Adjunct: A Comparison of Conductive Fabric Versus Forced-air and Water. Surg Technol Int. 2019 May 15;34:40-45.
• Williams M, El-Houdiri Y. Inadvertent hypothermia in hip and knee total joint arthroplasty. J Orthop. 2018 Jan 20;15(1):151-158. doi: 10.1016/j.jor.2018.01.035. eCollection 2018 Mar.
• Aksu C, Kus A, Gurkan Y, Solak M, Toker K. Survey on Postoperative Hypothermia Incidence In Operating Theatres of Kocaeli University. Turk J Anaesthesiol Reanim. 2014 Apr;42(2):66-70. doi: 10.5152/TJAR.2014.15010. Epub 2014 Jan 6.

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2021
• Primary Completion (Actual): October 13, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: April 6, 2022
• First Submitted That Met QC Criteria: May 27, 2022
• First Posted (Actual): May 31, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 23, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: hypothermia; femoroacetabular impingement; hip arthroscopy; rectal temperature
• Additional Relevant MeSH Terms: Body Temperature Changes; Musculoskeletal Diseases; Hypothermia
• Other Study ID Numbers: E2-21-862

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: The data will be available at the end of the study for a period of 6 months.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No