NCT06010069

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2022

Shorter than P25 for all trials

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

November 30, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 24, 2023

Completed
Last Updated

August 24, 2023

Status Verified

August 1, 2023

Enrollment Period

6 months

First QC Date

August 21, 2023

Last Update Submit

August 21, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • frequency of hypothermia

    difference between frailty groups in terms of frequency of hypothermia

    during the orthopedic surgical procedure

Study Arms (3)

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

frail patients

That patient group have clinical frailty scale scores 4 or 5 which is accepted as frail.

Diagnostic Test: body temperature measurament

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

Interventions

body temperature of every patient was measured with tympanic thermometer during surgical procedure

frail patientspre-frail patientsvery frail patients

Eligibility Criteria

Age65 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Elective Orthopedic Surgery Candidates
  • years old or older

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırşehir Eğitim ve Araştırma Hastanesi

Kırşehir, Merkez, 04100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Docdor

Study Record Dates

First Submitted

August 21, 2023

First Posted

August 24, 2023

Study Start

November 30, 2022

Primary Completion

June 1, 2023

Study Completion

July 1, 2023

Last Updated

August 24, 2023

Record last verified: 2023-08

Locations