Clinical trial NCT05396924: Rectal Temperature Measurement in Detecting Hypothermia During Hip Arthroscopy
Official title: Is Rectal Temperature Measurement Quicker in Detecting Hypothermia During Hip Arthroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Arthropathy
Hypothermia
Orthopedic Disorder
Keywords: femoroacetabular impingement
hip arthroscopy
hypothermia
rectal temperature
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2022-05-31
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective randomized controlled study with sequential randomization; the first patient will be included in the 1st group, and the second patient will be included into the 2nd group. All patients scheduled for hip arthroscopy 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. 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 thermometer. Mean body temperatures measured from 2 different locations between the groups will be compared, and the probability of detecting early local and later general hypothermia from the rectal mucosa will be examined.
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: Is rectal temperature measurement more effective in detecting hypothermia?
timeFrame: During the intervention, every 15 minutes.
Secondary outcomes:
measure: Does the usage of warmed irrigation fluids avoid or delay intraoperative hypothermia during hip arthroscopy?
timeFrame: During the intervention, every 15 minutes.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital - Ankara Şehir Hastanesi
Study officials:
affiliation: Ankara City Hospital Bilkent
name: Kasım Kılıçarslan, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.