NCT05396924

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 13, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 31, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 13, 2023

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

February 25, 2025

Status Verified

February 1, 2025

Enrollment Period

2 years

First QC Date

April 6, 2022

Last Update Submit

February 23, 2025

Conditions

Hip ArthropathyHypothermiaOrthopedic Disorder

Keywords

femoroacetabular impingementhip arthroscopyhypothermiarectal temperature

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Does the usage of warmed irrigation fluids avoid or delay intraoperative hypothermia during hip arthroscopy?

    During the intervention, every 15 minutes.

Study Arms (2)

Room Group

ACTIVE COMPARATOR

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 measurementProcedure: Temporal temperature measurement

Warmed Group

ACTIVE COMPARATOR

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 measurementProcedure: Temporal temperature measurement

Interventions

Rectal temperature measurementPROCEDURE

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

Room GroupWarmed Group
Temporal temperature measurementPROCEDURE

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

Room GroupWarmed Group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara City Hospital - Ankara Şehir Hastanesi

Ankara, 06800, Turkey (Türkiye)

Location

Related Publications (8)

  • 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.

    PMID: 24183196BACKGROUND

  • 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.

    PMID: 34059046BACKGROUND

  • 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.

    PMID: 32128778BACKGROUND

  • 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.

    PMID: 31037721BACKGROUND

  • 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.

    PMID: 29379254BACKGROUND

  • 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.

    PMID: 29195854BACKGROUND

  • 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.

    PMID: 27366393BACKGROUND

  • 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.

    PMID: 40584085DERIVED

MeSH Terms

Conditions

HypothermiaMusculoskeletal DiseasesFemoracetabular Impingement

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsJoint DiseasesPathologic Processes

Study Officials

  • Kasım Kılıçarslan, MD

    Ankara City Hospital Bilkent

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Enrolled patients and investigator of final output data will be blinded to the study protocol. Care providers (surgeons, nurses and OR personnel) will not be blinded.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 6, 2022

First Posted

May 31, 2022

Study Start

October 13, 2021

Primary Completion

October 13, 2023

Study Completion

October 31, 2023

Last Updated

February 25, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
The data will be available at the end of the study for a period of 6 months.

Locations

TU(1)