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The Relationship Between the Frequency of Intraoperative Hypothermia and Fragility Scores

Sponsor
Kirsehir Ahi Evran Universitesi (Other)
Overall Status
Completed
CT.gov ID
NCT06010069
Collaborator
(none)
90
Enrollment
1
Location
7
Actual Duration (Months)
12.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: body temperature measurament

Study Design

Study Type:
Observational
Actual Enrollment :
90 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Relationship Between the Frequency of Intraoperative Hypothermia and Fragility Scores in the Elderly Patient Group. Prospective Cohort Study
Actual Study Start Date :
Nov 30, 2022
Actual Primary Completion Date :
Jun 1, 2023
Actual Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. frequency of hypothermia [during the orthopedic surgical procedure]

    difference between frailty groups in terms of frequency of hypothermia

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kırşehir Eğitim ve Araştırma Hastanesi Kırşehir Merkez Turkey 04100

Sponsors and Collaborators

  • Kirsehir Ahi Evran Universitesi

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fatma Nur Arslan, Medical Docdor, Kirsehir Ahi Evran Universitesi
ClinicalTrials.gov Identifier:
NCT06010069
Other Study ID Numbers:
  • 22.11.2022 No: 2022-21/187
First Posted:
Aug 24, 2023
Last Update Posted:
Aug 24, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hypothermia

Study Results

No Results Posted as of Aug 24, 2023