HypothermiaNCT04997694
Effect of Preoperative Active Warming and Passive Warming Methods on Perioperative Hypothermia
A study testing Pre Heating in people with Hypothermia and Perioperative Care, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
70% of surgical interventions are abdominal surgeries. Open abdominal surgery is performed in patients for whom minimally invasive approaches are not suitable. In these surgeries in which general anesthesia is used, the duration of the operation is longer, complications are more frequent, and postoperative recovery… Read more about this study
- Who is it for?
- Ages 18 to 88 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypothermia, Perioperative Care, Vital Signs
- What is being tested?
- Pre Heating
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Jun 2021to 18 Sep 2021
- Phase
- Interventional
- 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 18 to 88 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years and older,
- Patients with ASA III and below,
- Under elective general anesthesia, will undergo Open Abdominal Surgery,
- BMI of 18.5- 29.9 kg/m2,
- Without neurological, psychiatric, neuromuscular disease,
- Not addicted to alcohol and drugs,
Show all 11Show fewer
- Not mentally retarded,
- Does not use drugs that will affect thermoregulation such as vasodilators,
- No history of thyroid disease,
- Absence of body temperature of 36 0C and 37.5 0C on the morning of the operation,
- No complication developed during the surgical intervention and no blood transfusion was performed.
Who cannot join
- Refusal to participate in the research
- Complication developed during the operation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect Of Pre-Surgery Actıve And Passıve Heatıng On Post-Operatıve Hypothermıa, Lıfe Fındıngs And Temperature Comfort
70% of surgical interventions are abdominal surgeries. Open abdominal surgery is performed in patients for whom minimally invasive approaches are not suitable. In these surgeries in which general anesthesia is used, the duration of the operation is longer, complications are more frequent, and postoperative recovery occurs later. Low body temperature before surgery, preoperative fasting and fluid deprivation before anesthesia, exposure of large body surface areas, evaporative heat loss during skin preparation using volatile solutions, large open cavity or abdominal surgery longer operative time and exposure to anesthesia, during surgical intervention excessive blood loss etc. surgical intervention poses a risk for the formation of undesirable hypothermia.
Cardiovascular and respiratory system problems that may increase mortality due to hypothermia in surgical patients; may cause a decrease in heart rhythm, cardiac output, blood pressure and oxygen saturation, and an increased risk of cardiac arrest and ischemia. With the development of shivering, oxygen consumption increases and the "thermal comfort" of the patient deteriorates. The length of stay in the postoperative unit and hospital stay are prolonged, causing an increase in costs.
Read more
Among the rapid recovery protocols, it is recommended to pre-warm the patients in the preoperative period to maintain normothermia. Many complications are prevented by different methods and warming procedures performed in the perioperative period.
In our study, it was aimed to compare the effects of active and passive warming on hypothermia, vital signs and warmth comfort in the postoperative period in patients who will undergo open abdominal surgery.
Read the detailed description
Before starting the research, permission was obtained from Çukurova University Medical Faculty Balcalı Hospital General Surgery Department Academic Committee and Operating Room Committee, from Balcalı Hospital Chief Physician (Annex-11), and Çukurova Ethics Committee by the investigator . University Faculty of Medicine Non-Interventional Research Ethics Committee approval was received with the date and number of 10.04.2020/98-29 An application was made to the Scientific Research Projects Unit to support the project with all permissions. It has been approved as a Scientific Research Project.
In accordance with the results of the power analysis using the G power 3.1.9.2 program, it was planned to include 30 participants in the active warming group, 30 partici in the passive warming group and 30 participants in the control group, and a simple randomization method was used in the distribution. Sample for study groups Research data were collected in the operating room preoperative unit and postoperative unit between July 2020 and December 2020.
When the participants came to the preoperative unit before the operation, his vital signs, temperature comfort perception scale and shivering level, temperature and humidity of the room were measured by the investigator and recorded in the Personal Information Form, Vital Signs Monitoring Form, Temperature Comfort Perception Scale Form, Shivering Level Diagnostic Form. Before anesthesia was given, one group was heated with the 3M Bair Hugger Model 775 Heating Unit (Hot Air Blowing Warmer Blanket) with an active heating system and the other group with a passive heating system (wool blanket) for 20 minutes, routine application was made to the control group participants by the investigator . Vital signs, tremor levels and temperature comfort perception measurements were made at the 0th, 15th, and 30th minutes in the postoperative unit of the participants after the operation by the investigator . Statistical analyzes of the collected data were made using a package program called SPSS (IBM SPSS Statistics 24). Frequency tables and descriptive statistics were used to interpret the findings. In accordance with parametric methods, the "ANOVA" test (F-table value) was used to compare the measurement values of three or more independent groups, and the "RepeatedMeasures" test (F-Table) was used to compare the measurement values of three or more dependent groups. The "Mann-Whitney U" test (Z-table value) and the "Kruskal-Wallis H" test (χ2- table value) were used to compare the measurement values of two independent groups in accordance with non-parametric methods. ) method was used. "Wilcoxon" test (Z-table value) to compare measurement values of two dependent groups, "Friedman" test (χ2-table value) to compare measurement values of three or more dependent groups, "Pearson-χ2 To examine the relationships between two qualitative variables used "cross tables" were used.
- Conditions
- Hypothermia, Perioperative Care, Vital Signs, Rewarming
- Being tested
- Pre Heating
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre HeatingProcedure or surgery
Also called Pre Warming
Before anesthesia was given, the participants were warmed for 20 minutes with prewarming techniques. Presence of postoperative hypothermia, vital signs and temperature comfort level were evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Active Heating Group | Experimental | When the participants comes to the preoperative unit before the operation, vital signs, temperature comfort perception scale and shivering level, temperature and humidity measurements of the room are measured by the investigator and Personal Information Form Vital Signs Follow-up Form, Temperature Comfort Perception Scale- The form was recorded in the Shivering Level Diagnosis Form Filling.Before anesthesia was given, heating was performed with the 3M Bair Hugger Model 775 Heating Unit, which has an active heating system, for 20 minutes. The participants, whose surgery was completed, was taken to the postoperative recovery unit, where the vital signs, tremor level, temperature and humidity of the room were measured by the investigator and the Personal Information Form Vital Signs Follow-up Form Shivering Level Diagnosis Form was recorded. One participant was followed every 15 minutes until the body temperature reached 36 0C. Receives: Procedure: Pre Heating |
| Pasive Heating Group | Experimental | When the participants comes to the preoperative unit before the operation, vital signs, temperature comfort perception scale and shivering level, temperature and humidity measurements of the room are measured by the investigator and Personal Information Form ,Vital Signs Follow-up Form, Temperature Comfort Perception Scale. The form was recorded in the Shivering Level Diagnosis Form . Before anesthesia was given, heating was performed with a wool blanket, which is a passive heating method, for 20 minutes. The participants, whose surgery was completed, was taken to the postoperative recovery unit, where the vital signs, tremor level, temperature and humidity of the room were measured by the investigator and the Personal Information Form Vital Signs Follow-up Form , Shivering Level Diagnosis Form was recorded. One participant was followed every 15 minutes until the body temperature reached 36 0C. Receives: Procedure: Pre Heating |
| Control Group | No intervention | When the participants comes to the preoperative unit before the operation, vital signs, temperature comfort perception scale and shivering level, temperature and humidity measurements of the room are measured by the investigator and Personal Information Form Vital Signs Follow-up Form , Temperature Comfort Perception Scale The form was recorded in the Shivering Level Diagnosis Form the participants, whose surgery was completed, was taken to the postoperative recovery unit, where the vital signs, tremor level, temperature and humidity of the room were measured by the investigator and the Personal Information Form , Vital Signs Follow-up Form , Shivering Level Diagnosis Form was recorded. One participant was followed every 15 minutes until the body temperature reached 36 0C. |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in body temperature preheating process
The sample size was calculated by performing G-power power analysis. Pre-application measurements and 0., 15., 30. after application. Considering the temperature changes observed in the measurements obtained per minute, the effect size was found to be 0.1844. Accordingly, the number of samples required to achieve 90% power at α=0.05 level was calculated as 78 patients, including at least 26 active warming groups, 26 passive warming groups, and 26 control groups. In order to increase the power of the research, the study was conducted with a total of 90 patients, 30 from each group.
Participants with a body temperature below 36 0C were considered to be in hypothermia. Non-contact thermometer was used to measure body temperature.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start23 Jun 2021
- Primary completion23 Jul 2021
- Study completion18 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypothermiaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3 Group randomized
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Refiye Akpolat, Cukurova University
- Investigators
- Refiye Akpolat, Principal investigator, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04997694
- Sponsor's protocol ID
- 0000-0001-8907-0651
- Status last verified
- Mar 2022
- First submitted
- 23 Jun 2021
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akpolat R, Arslan S. Effect of Prewarming on Postoperative Hypothermia, Vital Signs, and Thermal Comfort: A Randomized Controlled Trial. Ther Hypothermia Temp Manag. 2024 Jun;14(2):89-98. doi: 10.1089/ther.2023.0017. Epub 2023 Jun 16.
PubMed 37327382
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Pre-Surgery Actıve And Passıve Heatıng On Post-Operatıve Hypothermıa, Lıfe Fındıngs And Temperature Comfort
- ClinicalTrials.gov ID
- NCT04997694
- Acronym / sponsor ID
- 0000-0001-8907-0651
- Conditions
- Hypothermia, Perioperative Care, Vital Signs, Rewarming
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 23 Jun 2021 (actual)
- Primary completion
- 23 Jul 2021 (actual)
- Study completion
- 18 Sep 2021 (actual)
- First posted
- 10 Aug 2021 (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.
70% of surgical interventions are abdominal surgeries. Open abdominal surgery is performed in patients for whom minimally invasive approaches are not suitable. In these surgeries in which general anesthesia is used, the duration of the operation is longer, complications are more frequent, and postoperative recovery occurs later. Low body temperature before surgery, preoperative fasting and fluid deprivation before anesthesia, exposure of large body surface areas, evaporative heat loss during skin preparation using volatile solutions, large open cavity or abdominal surgery longer operative time and exposure to anesthesia, during surgical intervention excessive blood loss etc. surgical intervention poses a risk for the formation of undesirable hypothermia.
Cardiovascular and respiratory system problems that may increase mortality due to hypothermia in surgical patients; may cause a decrease in heart rhythm, cardiac output, blood pressure and oxygen saturation, and an increased risk of cardiac arrest and ischemia. With the development of shivering, oxygen consumption increases and the "thermal comfort" of the patient deteriorates. The length of stay in the postoperative unit and hospital stay are prolonged, causing an increase in costs.
Among the rapid recovery protocols, it is recommended to pre-warm the patients in the preoperative period to maintain normothermia. Many complications are prevented by different methods and warming procedures performed in the perioperative period.
In our study, it was aimed to compare the effects of active and passive warming on hypothermia, vital signs and warmth comfort in the postoperative period in patients who will undergo open abdominal surgery.
Detailed description
Before starting the research, permission was obtained from Çukurova University Medical Faculty Balcalı Hospital General Surgery Department Academic Committee and Operating Room Committee, from Balcalı Hospital Chief Physician (Annex-11), and Çukurova Ethics Committee by the investigator . University Faculty of Medicine Non-Interventional Research Ethics Committee approval was received with the date and number of 10.04.2020/98-29 An application was made to the Scientific Research Projects Unit to support the project with all permissions. It has been approved as a Scientific Research Project.
In accordance with the results of the power analysis using the G power 3.1.9.2 program, it was planned to include 30 participants in the active warming group, 30 partici in the passive warming group and 30 participants in the control group, and a simple randomization method was used in the distribution. Sample for study groups Research data were collected in the operating room preoperative unit and postoperative unit between July 2020 and December 2020.
When the participants came to the preoperative unit before the operation, his vital signs, temperature comfort perception scale and shivering level, temperature and humidity of the room were measured by the investigator and recorded in the Personal Information Form, Vital Signs Monitoring Form, Temperature Comfort Perception Scale Form, Shivering Level Diagnostic Form. Before anesthesia was given, one group was heated with the 3M Bair Hugger Model 775 Heating Unit (Hot Air Blowing Warmer Blanket) with an active heating system and the other group with a passive heating system (wool blanket) for 20 minutes, routine application was made to the control group participants by the investigator . Vital signs, tremor levels and temperature comfort perception measurements were made at the 0th, 15th, and 30th minutes in the postoperative unit of the participants after the operation by the investigator . Statistical analyzes of the collected data were made using a package program called SPSS (IBM SPSS Statistics 24). Frequency tables and descriptive statistics were used to interpret the findings. In accordance with parametric methods, the "ANOVA" test (F-table value) was used to compare the measurement values of three or more independent groups, and the "RepeatedMeasures" test (F-Table) was used to compare the measurement values of three or more dependent groups. The "Mann-Whitney U" test (Z-table value) and the "Kruskal-Wallis H" test (χ2- table value) were used to compare the measurement values of two independent groups in accordance with non-parametric methods. ) method was used. "Wilcoxon" test (Z-table value) to compare measurement values of two dependent groups, "Friedman" test (χ2-table value) to compare measurement values of three or more dependent groups, "Pearson-χ2 To examine the relationships between two qualitative variables used "cross tables" were used.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- 3 Group randomized
| Arm | Type | Receives |
|---|---|---|
| Active Heating Group | Experimental | Procedure: Pre HeatingWhen the participants comes to the preoperative unit before the operation, vital signs, temperature comfort perception scale and shivering level, temperature and humidity measurements of the room are measured by the investigator and Personal Information Form Vital Signs Follow-up Form, Temperature Comfort Perception Scale- The form was recorded in the Shivering Level Diagnosis Form Filling.Before anesthesia was given, heating was performed with the 3M Bair Hugger Model 775 Heating Unit, which has an active heating system, for 20 minutes. The participants, whose surgery was completed, was taken to the postoperative recovery unit, where the vital signs, tremor level, temperature and humidity of the room were measured by the investigator and the Personal Information Form Vital Signs Follow-up Form Shivering Level Diagnosis Form was recorded. One participant was followed every 15 minutes until the body temperature reached 36 0C. |
| Pasive Heating Group | Experimental | Procedure: Pre HeatingWhen the participants comes to the preoperative unit before the operation, vital signs, temperature comfort perception scale and shivering level, temperature and humidity measurements of the room are measured by the investigator and Personal Information Form ,Vital Signs Follow-up Form, Temperature Comfort Perception Scale. The form was recorded in the Shivering Level Diagnosis Form . Before anesthesia was given, heating was performed with a wool blanket, which is a passive heating method, for 20 minutes. The participants, whose surgery was completed, was taken to the postoperative recovery unit, where the vital signs, tremor level, temperature and humidity of the room were measured by the investigator and the Personal Information Form Vital Signs Follow-up Form , Shivering Level Diagnosis Form was recorded. One participant was followed every 15 minutes until the body temperature reached 36 0C. |
| Control Group | No intervention | –When the participants comes to the preoperative unit before the operation, vital signs, temperature comfort perception scale and shivering level, temperature and humidity measurements of the room are measured by the investigator and Personal Information Form Vital Signs Follow-up Form , Temperature Comfort Perception Scale The form was recorded in the Shivering Level Diagnosis Form the participants, whose surgery was completed, was taken to the postoperative recovery unit, where the vital signs, tremor level, temperature and humidity of the room were measured by the investigator and the Personal Information Form , Vital Signs Follow-up Form , Shivering Level Diagnosis Form was recorded. One participant was followed every 15 minutes until the body temperature reached 36 0C. |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 18 years and older,
- Patients with ASA III and below,
- Under elective general anesthesia, will undergo Open Abdominal Surgery,
- BMI of 18.5- 29.9 kg/m2,
- Without neurological, psychiatric, neuromuscular disease,
Key exclusion criteria (2 listed)
- Refusal to participate in the research
- Complication developed during the operation
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 |
|---|---|---|
| Pre HeatingAlso: Pre WarmingBefore anesthesia was given, the participants were warmed for 20 minutes with prewarming techniques. Presence of postoperative hypothermia, vital signs and temperature comfort level were evaluated. | Procedure or surgery | Active Heating Group, Pasive Heating Group |
Primary outcome
changes in body temperature preheating process
Time frame: 30 minutes
The sample size was calculated by performing G-power power analysis. Pre-application measurements and 0., 15., 30. after application. Considering the temperature changes observed in the measurements obtained per minute, the effect size was found to be 0.1844. Accordingly, the number of samples required to achieve 90% power at α=0.05 level was calculated as 78 patients, including at least 26 active warming groups, 26 passive warming groups, and 26 control groups. In order to increase the power of the research, the study was conducted with a total of 90 patients, 30 from each group. Participants with a body temperature below 36 0C were considered to be in hypothermia. Non-contact thermometer was used to measure body temperature.
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 9 Mar 2022.
- Derived from this study: PubMed 37327382Akpolat R, Arslan S. Effect of Prewarming on Postoperative Hypothermia, Vital Signs, and Thermal Comfort: A Randomized Controlled Trial. Ther Hypothermia Temp Manag. 2024 Jun;14(2):89-98. doi: 10.1089/ther.2023.0017. Epub 2023 Jun 16.
- Individual participant dataSharing planned: No
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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.
Refiye Akpolat principal investigator
Cukurova University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre Heating in people with Hypothermia and Perioperative Care, run by Cukurova University 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 11 inclusion and 2 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 9 Mar 2022. 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?
changes in body temperature preheating process (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04997694, which also lists 1 linked publication.
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 9 Mar 2022.