Rectal Temperature Measurement in Detecting Hypothermia During Hip Arthroscopy

NCT ID: NCT05396924

Last Updated: 2025-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-13
• Study Completion Date: 2023-10-31

Brief Summary

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.

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.

Conditions

Hip Arthropathy; Hypothermia; Orthopedic Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Rectal temperature measurement

Intervention Type: PROCEDURE

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

Temporal temperature measurement

Intervention Type: PROCEDURE

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

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.

Group Type: ACTIVE_COMPARATOR

Rectal temperature measurement

Intervention Type: PROCEDURE

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

Temporal temperature measurement

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara City Hospital Bilkent

OTHER

Sponsor Role: lead

Responsible Party

Enejd Veizi, MD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kasım Kılıçarslan, MD

Role: STUDY_DIRECTOR

Ankara City Hospital Bilkent

Locations

Ankara City Hospital - Ankara Şehir Hastanesi

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 24183196 (View on PubMed)

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Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

PMID: 29379254 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29195854 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27366393 (View on PubMed)

Firat A, Veizi E, Kalayci I, Sezgin BS, Erdogan Y, Gursoy S, Capurro-Soler B, Koutserimpas C. Heated Irrigation Fluids Did Not Reduce the Prevalence of Rectally Measured Hypothermia During Hip Arthroscopic Surgery Compared With Room-Temperature Fluids: A Prospective Randomized Trial. Orthop J Sports Med. 2025 Jun 26;13(6):23259671251350401. doi: 10.1177/23259671251350401. eCollection 2025 Jun.

Reference Type: DERIVED

PMID: 40584085 (View on PubMed)

Other Identifiers

E2-21-862

Identifier Type: -

Identifier Source: org_study_id