Rectal Temperature Measurement in Detecting Hypothermia During Hip Arthroscopy

Sponsor
Ankara City Hospital Bilkent (Other)
Overall Status
Recruiting
CT.gov ID
NCT05396924
Collaborator
(none)
100
1
2
24.6
4.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Rectal temperature measurement
  • Procedure: Temporal temperature measurement
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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.
Masking:
Double (Participant, Investigator)
Masking Description:
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.
Primary Purpose:
Prevention
Official Title:
Is Rectal Temperature Measurement Quicker in Detecting Hypothermia During Hip Arthroscopy
Actual Study Start Date :
Oct 13, 2021
Anticipated Primary Completion Date :
Oct 13, 2023
Anticipated Study Completion Date :
Oct 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Is rectal temperature measurement more effective in detecting hypothermia? [During the intervention, every 15 minutes.]

    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.

Secondary Outcome Measures

  1. Does the usage of warmed irrigation fluids avoid or delay intraoperative hypothermia during hip arthroscopy? [During the intervention, every 15 minutes.]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ankara City Hospital - Ankara Şehir Hastanesi Ankara Turkey 06800

Sponsors and Collaborators

  • Ankara City Hospital Bilkent

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ankara City Hospital Bilkent
ClinicalTrials.gov Identifier:
NCT05396924
Other Study ID Numbers:
  • E2-21-862
First Posted:
May 31, 2022
Last Update Posted:
May 31, 2022
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ankara City Hospital Bilkent
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 31, 2022