Rectal Temperature Measurement in Detecting Hypothermia During Hip Arthroscopy

February 23, 2025 updated by: Enejd Veizi, MD, Ankara City Hospital Bilkent

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
116

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Is rectal temperature measurement more effective in detecting hypothermia?
Time Frame: 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.
During the intervention, every 15 minutes.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Does the usage of warmed irrigation fluids avoid or delay intraoperative hypothermia during hip arthroscopy?
Time Frame: 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.
During the intervention, every 15 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ankara City Hospital Bilkent

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Kasım Kılıçarslan, MD, Ankara City Hospital Bilkent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 13, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 13, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 6, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 31, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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