The Relationship Between the Frequency of Intraoperative Hypothermia and Fragility Scores

August 21, 2023 updated by: Fatma Nur Arslan, Kirsehir Ahi Evran Universitesi

The Relationship Between the Frequency of Intraoperative Hypothermia and Fragility Scores in the Elderly Patient Group. Prospective Cohort Study

The goal of this observational study is to compare frequency of intraoperative hypothermia between fragilitly groups of eldery patients who underwent orthopedic surgical procedures.

It aims to answer those questions:

  • İs there any difference between fragility groups in terms of hypothermia frequency during orthopedic surgical procedures?
  • Are there any other factors that influence the frequency of hypothermia such as age, body mass index, room temperature etc. ? Participants body temperature before anestesia application,and before surgery had started was measured and measurament was done during whole procedure. Measuraments had been done by tympanic thermometer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

90

Contacts and Locations

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

Study Locations

  • Turkey
    • Merkez
      • Kırşehir, Merkez, Turkey, 04100
        • Kırşehir Eğitim ve Araştırma 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

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Our candidates was choosen from patiens who scheduled for elective orthopedic surgeries in Kirsehir education and research hospital. We have enrolled patients who accepted to be a partician for this study after obtaining their informed consent. Elective Orthopedic Surgery. All of our participants were 65 years old or older.

Description

Inclusion Criteria:

  • Elective Orthopedic Surgery Candidates
  • 65 years old or older

Exclusion Criteria:

  • Emergency surgery
  • Patiens who required multiple (2 or more) blood component transfusions
  • Neurologic disorders
  • tyroid dysfunction
  • Patiens who are already hypothermic before surgery

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
pre-frail patients
That patient group have clinical frailty scale scores 1,2 or 3 which is accepted as non-frail.
Diagnostic test: body temperature measurament
body temperature of every patient was measured with tympanic thermometer during surgical procedure
frail patients
That patient group have clinical frailty scale scores 4 or 5 which is accepted as frail.
Diagnostic test: body temperature measurament
body temperature of every patient was measured with tympanic thermometer during surgical procedure
very frail patients
That patient group have clinical frailty scale scores 6,7,8 or 9 which is accepted as severly frail.
Diagnostic test: body temperature measurament
body temperature of every patient was measured with tympanic thermometer during surgical procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
frequency of hypothermia
Time Frame: during the orthopedic surgical procedure
difference between frailty groups in terms of frequency of hypothermia
during the orthopedic surgical procedure

Collaborators and Investigators

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

Sponsor

Kirsehir Ahi Evran Universitesi

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)

November 30, 2022

Primary Completion (Actual)

June 1, 2023

Study Completion (Actual)

July 1, 2023

Study Registration Dates

First Submitted

August 21, 2023

First Submitted That Met QC Criteria

August 21, 2023

First Posted (Actual)

August 24, 2023

Study Record Updates

Last Update Posted (Actual)

August 24, 2023

Last Update Submitted That Met QC Criteria

August 21, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22.11.2022 No: 2022-21/187

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

After the statistical analyzes we will most likely to share IPDs

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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