Hypothermia; AnesthesiaNCT06010069
The Relationship Between the Frequency of Intraoperative Hypothermia and Fragility Scores
An observational study of Hypothermia; Anesthesia and Fragility, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Hypothermia; Anesthesia, Fragility
- What is being tested?
- body temperature measurament
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Nov 2022to 1 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- Elective Orthopedic Surgery Candidates
- 65 years old or older
Who cannot join
- Emergency surgery
- Patiens who required multiple (2 or more) blood component transfusions
- Neurologic disorders
- tyroid dysfunction
- Patiens who are already hypothermic before surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kırşehir Eğitim ve Araştırma Hastanesi
Kırşehir, Merkez, 04100
About this study
Official title: 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.
- Conditions
- Hypothermia; Anesthesia, Fragility
- Being tested
- body temperature measurament
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
body temperature measuramentDiagnostic test
body temperature of every patient was measured with tympanic thermometer during surgical procedure
| Study group | Role | What they receive |
|---|---|---|
| pre-frail patients | That patient group have clinical frailty scale scores 1,2 or 3 which is accepted as non-frail. Receives: Diagnostic Test: body temperature measurament | |
| frail patients | That patient group have clinical frailty scale scores 4 or 5 which is accepted as frail. Receives: 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. Receives: Diagnostic Test: body temperature measurament |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of hypothermia
difference between frailty groups in terms of frequency of hypothermia
Measured: during the orthopedic surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start30 Nov 2022
- Primary completion1 Jun 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypothermia; AnesthesiaStudies of the same condition, open and under way.
- More trials run by Kirsehir Ahi Evran UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Nur Arslan, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06010069
- Sponsor's protocol ID
- 22.11.2022 No: 2022-21/187
- Status last verified
- Aug 2023
- First submitted
- 21 Aug 2023
- Last updated
- 24 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: After the statistical analyzes we will most likely to share IPDs
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between the Frequency of Intraoperative Hypothermia and Fragility Scores in the Elderly Patient Group. Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06010069
- Acronym / sponsor ID
- 22.11.2022 No: 2022-21/187
- Conditions
- Hypothermia; Anesthesia, Fragility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 24 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| pre-frail patients | – | Diagnostic Test: body temperature measuramentThat patient group have clinical frailty scale scores 1,2 or 3 which is accepted as non-frail. |
| frail patients | – | Diagnostic Test: body temperature measuramentThat patient group have clinical frailty scale scores 4 or 5 which is accepted as frail. |
| very frail patients | – | Diagnostic Test: body temperature measuramentThat patient group have clinical frailty scale scores 6,7,8 or 9 which is accepted as severly frail. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (2 listed)
- Elective Orthopedic Surgery Candidates
- 65 years old or older
Key exclusion criteria (5 listed)
- Emergency surgery
- Patiens who required multiple (2 or more) blood component transfusions
- Neurologic disorders
- tyroid dysfunction
- Patiens who are already hypothermic before surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| body temperature measuramentbody temperature of every patient was measured with tympanic thermometer during surgical procedure | Diagnostic test | frail patients, pre-frail patients, very frail patients |
Primary outcome
frequency of hypothermia
Time frame: during the orthopedic surgical procedure
difference between frailty groups in terms of frequency of hypothermia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- Individual participant dataSharing planned: Undecided. After the statistical analyzes we will most likely to share IPDs
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Not yet recruitingPhase 4
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypothermia; Anesthesia and Fragility, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequency of hypothermia (time frame: during the orthopedic surgical procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2023.