Postoperative HypothermiaNCT06829017
Pilot Implementation of the Postoperative Hypothermia Management Care Bundle
A study testing Postoperative Hypothermia Management Care Bundle in people with Postoperative Hypothermia, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Inadvertent perioperative hypothermia (IPH) is a common complication in surgical patients, with incidence rates ranging between 50% and 90% in anaesthetised individuals. This study aims to pilot and evaluate the effectiveness of a Postoperative Hypothermia Management Care Bundle developed based on standardised… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Postoperative Hypothermia
- What is being tested?
- Postoperative Hypothermia Management Care Bundle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2026to 30 Jun 2026
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For Nurses
- Working as a nurse in Cardiovascular Surgery Intensive Care Unit for at least 6 months
- Volunteering to participate in the study
- For patients to be cared for during the pilot implementation of the care bundle:
- 18 years of age or older
- Being in the first 24 hours of postoperative follow-up in the Cardiovascular Surgery Intensive Care Unit
- He/she or his/her legal representative has given consent to participate in the study
Who cannot join
- For nurses
- Leaving the Cardiovascular Surgery Intensive Care Unit before the completion of the study period
- Unwillingness to continue working
- For patients to be cared for during the piloting of the care package:
- Emergency surgical operations, patients with abnormal thermoregulation such as malignant hyperthermia and neuroleptic malignant syndrome and patients with ASA IV-V
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University adult hospital
Ankara, ABD Veya Kanada'daysanız Lütfen Seçin..., 06230
About this study
Official title: Pilot Implementation and Evaluation of the Effectiveness of the Postoperative Hypothermia Management Care Bundle
Inadvertent perioperative hypothermia (IPH) is a common complication in surgical patients, with incidence rates ranging between 50% and 90% in anaesthetised individuals. This study aims to pilot and evaluate the effectiveness of a Postoperative Hypothermia Management Care Bundle developed based on standardised, evidence-based practices.
The study will be conducted using a mixed-methods design in two phases.
Read more
In the first phase, the care bundle will be piloted over six months in the Cardiovascular Surgery Intensive Care Unit.
In the second phase, the bundle's effectiveness will be assessed using both quantitative and qualitative data.
The study population includes nurses working in the relevant intensive care unit who meet inclusion criteria and volunteer to participate.
Data collection tools include:
Nurse Descriptive Information Form
Postoperative Hypothermia Management Care Bundle Checklist
Care Bundle Compliance Assessment Form
Semi-structured Nurse Interview Questionnaire (qualitative)
Patient Postoperative Hypothermia Follow-up Form
Quantitative data will be analysed using descriptive statistics. Compliance with the care bundle will be calculated as the ratio of patients who received all care bundle parameters to those who should have received them. A compliance rate below 95% will be considered unsuccessful. Qualitative data will be analysed using Colaizzi's seven-step phenomenological method.
Read the detailed description
Background and Rationale
Inadvertent perioperative hypothermia (IPH) is one of the most common perioperative problems in surgical patients. In the literature, IPH rates in anesthetized patients are reported between 50-90%. Guidelines for preventing and managing IPH in surgical patients have been developed. Although there are clinical practice guidelines for the management of IPH, the incidence of IPH in surgical patients is still high. Reducing the incidence of IPH in surgical patients depends on good management of hypothermia in the perioperative process, and nurses have important responsibilities at every stage of the perioperative process in the management of IPH. Nurses, who play a key role in the multidisciplinary team in the management of IPH, still experience some problems in the management of hypothermia. Good management of IPH, which is a preventable problem in the surgical process, may be possible with evidence-based standardization of practices in the perioperative process and systematic implementation of these practices.
Care Bundles for Hypothermia Management
In recent years, Care Bundles (CB) have been used to standardize nursing practices based on evidence and to improve the quality of care. CB is defined as a set of evidence-based practices used to standardize care and treatment. CBs are reported to have many benefits such as providing easy management of conditions requiring special care, reducing complications, increasing communication within the team, improving the quality of care, and providing supervision. In addition, it has been reported that the use of CB increases the satisfaction of patients and nurses and job satisfaction of nurses, reduces unnecessary applications in nursing care, and improves negative patient outcomes that may result from inadequate care. In the literature, there is a CB developed for the management of perioperative hypothermia. The perioperative thermal CB developed by Duff et al. (2018) includes three elements: risk assessment, body temperature monitoring, and active warming. The three elements in this CB are recommendations for preoperative, intraoperative, and postoperative processes, and it is evident that the majority of the applications are for the intraoperative phase. In the study, it was found that compliance with the CB, especially the practices in the intraoperative process, was low. It is thought that the development and use of a CB specific to each stage of the perioperative process in the management of IPH will increase the applicability of the CB and compliance with the bundle. In the literature, there is no CB developed for the management of hypothermia in the postoperative period. Therefore, a CB specific to the postoperative process was developed to standardize nursing care for hypothermia in surgical patients, improve patient outcomes, and increase the quality of care. This CB was prepared in line with the approaches recommended by the Institute for Healthcare Improvement (IHI) for the management of postoperative hypothermia.
Study Objectives This study evaluates the pilot implementation and effectiveness of the postoperative hypothermia management CB developed within the scope of the research.
Study Design and Setting This study was planned as mixed-method research in which qualitative and quantitative research methods were used together. The study is planned to be conducted in the Cardiovascular Surgery Intensive Care Unit of Hacettepe University Adult Hospital between 15 August 2025 and 31 March 2026 following the approval of the ethics committee.
Participants and Eligibility Criteria Participants include nurses working in the Cardiovascular Surgery Intensive Care Unit and patients hospitalized there. Inclusion criteria for nurses include at least 6 months working experience in the unit and voluntary participation. Patients must be 18 years or older, within the first 24 hours of postoperative follow-up, and must consent to participate.
Intervention: Postoperative Hypothermia Care Bundle The postoperative hypothermia CB consists of three main parameters: 'Diagnose hypothermia', 'Maintain/maintain normothermia', and 'Monitor body temperature at regular intervals', and eight sub-parameters. The CB was developed using literature review, expert consultation through Delphi method, and finalized after two rounds with 11 experts.
Data Collection Tools
- Nurse Descriptive Information Form
- Postoperative Hypothermia Management Care Bundle Checklist
- Compliance Assessment Form
- Semi-structured Questionnaire for Nurses
- Patient Postoperative Hypothermia Follow-up Form
Procedure The study will be conducted in two phases: (1) pilot implementation of the CB and (2) evaluation of its effectiveness. Nurses will be trained and asked to use the CB checklist during their shifts for six months. Researchers will assess compliance and conduct qualitative interviews to evaluate nurse experiences. Data on hypothermia incidence and normothermia recovery time will also be collected.
Data Analysis Quantitative data will be analyzed using SPSS 23.0; descriptive statistics will be presented as means, standard deviations, medians, and percentages. Qualitative data will be analyzed using Colaizzi's seven-step phenomenological method. Compliance with the CB will be calculated and compared against a 95% threshold to assess success.
- Conditions
- Postoperative Hypothermia
- Being tested
- Postoperative Hypothermia Management Care Bundle
- Keywords
- postoperative hypothermia, care bundle, nursing, surgery, postoperative care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative Hypothermia Management Care BundleOther
The postoperative hypothermia care bundle consists of three main parameters, "Diagnose hypothermia", "Maintain/maintain normothermia" and "Monitor body temperature at regular intervals", and eight sub-parameters of these parameters. For this purpose, this study evaluates the pilot implementation and effectiveness of the postoperative hypothermia management care bundle developed within the scope of the research.
| Study group | Role | What they receive |
|---|---|---|
| the pilot implementation and effectiveness of the postoperative hypothermia management care bundle | Other | Not described Receives: Other: Postoperative Hypothermia Management Care Bundle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Care bundles compliance assessment form for postoperative hypothermia management
This form was developed by the researchers to evaluate the nurses' application of the care bundle to the patients. The boxes 'applied', 'not applied' if not applied, and 'not filled' if the control form is not marked will be ticked on the compliance assessment form in which the care bundle parameters are applied. Within the scope of this form, the compliance rate of the care bundle will be calculated. The rate found with this calculation will show the success of compliance with the maintenance bundle. In the calculation, the compliance rate will be calculated by dividing the number of patients to whom all parameters of the care bundle are fully implemented within the scope of the research by the number of patients to whom the care bundle parameters should be implemented. In this calculation, if the compliance rate is below 95%, it means that compliance with the care bundle is unsuccessful.
Measured: 15 August 2025-28 February 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start1 Jan 2026
- Primary completion20 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative HypothermiaStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Balkan, Hacettepe University
- Investigators
- Zeliha OZDEMIR KOKEN, ASSOCIATE PROFESSOR, Study director, Hacettepe University Faculty of NursingMustafa YILMAZ, PROFESSOR, Study chair, Hacettepe University Medicine Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06829017
- Status last verified
- Aug 2026
- First submitted
- 9 Feb 2025
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Implementation and Evaluation of the Effectiveness of the Postoperative Hypothermia Management Care Bundle
- ClinicalTrials.gov ID
- NCT06829017
- Conditions
- Postoperative Hypothermia
- Keywords
- postoperative hypothermia, care bundle, nursing, surgery, postoperative care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 20 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 17 Feb 2025 (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.
Inadvertent perioperative hypothermia (IPH) is a common complication in surgical patients, with incidence rates ranging between 50% and 90% in anaesthetised individuals. This study aims to pilot and evaluate the effectiveness of a Postoperative Hypothermia Management Care Bundle developed based on standardised, evidence-based practices.
The study will be conducted using a mixed-methods design in two phases.
In the first phase, the care bundle will be piloted over six months in the Cardiovascular Surgery Intensive Care Unit.
In the second phase, the bundle's effectiveness will be assessed using both quantitative and qualitative data.
The study population includes nurses working in the relevant intensive care unit who meet inclusion criteria and volunteer to participate.
Data collection tools include:
Nurse Descriptive Information Form
Postoperative Hypothermia Management Care Bundle Checklist
Care Bundle Compliance Assessment Form
Semi-structured Nurse Interview Questionnaire (qualitative)
Patient Postoperative Hypothermia Follow-up Form
Quantitative data will be analysed using descriptive statistics. Compliance with the care bundle will be calculated as the ratio of patients who received all care bundle parameters to those who should have received them. A compliance rate below 95% will be considered unsuccessful. Qualitative data will be analysed using Colaizzi's seven-step phenomenological method.
Detailed description
Background and Rationale
Inadvertent perioperative hypothermia (IPH) is one of the most common perioperative problems in surgical patients. In the literature, IPH rates in anesthetized patients are reported between 50-90%. Guidelines for preventing and managing IPH in surgical patients have been developed. Although there are clinical practice guidelines for the management of IPH, the incidence of IPH in surgical patients is still high. Reducing the incidence of IPH in surgical patients depends on good management of hypothermia in the perioperative process, and nurses have important responsibilities at every stage of the perioperative process in the management of IPH. Nurses, who play a key role in the multidisciplinary team in the management of IPH, still experience some problems in the management of hypothermia. Good management of IPH, which is a preventable problem in the surgical process, may be possible with evidence-based standardization of practices in the perioperative process and systematic implementation of these practices.
Care Bundles for Hypothermia Management
In recent years, Care Bundles (CB) have been used to standardize nursing practices based on evidence and to improve the quality of care. CB is defined as a set of evidence-based practices used to standardize care and treatment. CBs are reported to have many benefits such as providing easy management of conditions requiring special care, reducing complications, increasing communication within the team, improving the quality of care, and providing supervision. In addition, it has been reported that the use of CB increases the satisfaction of patients and nurses and job satisfaction of nurses, reduces unnecessary applications in nursing care, and improves negative patient outcomes that may result from inadequate care. In the literature, there is a CB developed for the management of perioperative hypothermia. The perioperative thermal CB developed by Duff et al. (2018) includes three elements: risk assessment, body temperature monitoring, and active warming. The three elements in this CB are recommendations for preoperative, intraoperative, and postoperative processes, and it is evident that the majority of the applications are for the intraoperative phase. In the study, it was found that compliance with the CB, especially the practices in the intraoperative process, was low. It is thought that the development and use of a CB specific to each stage of the perioperative process in the management of IPH will increase the applicability of the CB and compliance with the bundle. In the literature, there is no CB developed for the management of hypothermia in the postoperative period. Therefore, a CB specific to the postoperative process was developed to standardize nursing care for hypothermia in surgical patients, improve patient outcomes, and increase the quality of care. This CB was prepared in line with the approaches recommended by the Institute for Healthcare Improvement (IHI) for the management of postoperative hypothermia.
Study Objectives This study evaluates the pilot implementation and effectiveness of the postoperative hypothermia management CB developed within the scope of the research.
Study Design and Setting This study was planned as mixed-method research in which qualitative and quantitative research methods were used together. The study is planned to be conducted in the Cardiovascular Surgery Intensive Care Unit of Hacettepe University Adult Hospital between 15 August 2025 and 31 March 2026 following the approval of the ethics committee.
Participants and Eligibility Criteria Participants include nurses working in the Cardiovascular Surgery Intensive Care Unit and patients hospitalized there. Inclusion criteria for nurses include at least 6 months working experience in the unit and voluntary participation. Patients must be 18 years or older, within the first 24 hours of postoperative follow-up, and must consent to participate.
Intervention: Postoperative Hypothermia Care Bundle The postoperative hypothermia CB consists of three main parameters: 'Diagnose hypothermia', 'Maintain/maintain normothermia', and 'Monitor body temperature at regular intervals', and eight sub-parameters. The CB was developed using literature review, expert consultation through Delphi method, and finalized after two rounds with 11 experts.
Data Collection Tools
- Nurse Descriptive Information Form
- Postoperative Hypothermia Management Care Bundle Checklist
- Compliance Assessment Form
- Semi-structured Questionnaire for Nurses
- Patient Postoperative Hypothermia Follow-up Form
Procedure The study will be conducted in two phases: (1) pilot implementation of the CB and (2) evaluation of its effectiveness. Nurses will be trained and asked to use the CB checklist during their shifts for six months. Researchers will assess compliance and conduct qualitative interviews to evaluate nurse experiences. Data on hypothermia incidence and normothermia recovery time will also be collected.
Data Analysis Quantitative data will be analyzed using SPSS 23.0; descriptive statistics will be presented as means, standard deviations, medians, and percentages. Qualitative data will be analyzed using Colaizzi's seven-step phenomenological method. Compliance with the CB will be calculated and compared against a 95% threshold to assess success.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| the pilot implementation and effectiveness of the postoperative hypothermia management care bundle | Other | Other: Postoperative Hypothermia Management Care Bundle |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- For Nurses
- Working as a nurse in Cardiovascular Surgery Intensive Care Unit for at least 6 months
- Volunteering to participate in the study
- 18 years of age or older
- Being in the first 24 hours of postoperative follow-up in the Cardiovascular Surgery Intensive Care Unit
Key exclusion criteria (5 listed)
- For nurses
- Leaving the Cardiovascular Surgery Intensive Care Unit before the completion of the study period
- Unwillingness to continue working
- Emergency surgical operations, patients with abnormal thermoregulation such as malignant hyperthermia and neuroleptic malignant syndrome and patients with ASA IV-V
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 |
|---|---|---|
| Postoperative Hypothermia Management Care BundleThe postoperative hypothermia care bundle consists of three main parameters, "Diagnose hypothermia", "Maintain/maintain normothermia" and "Monitor body temperature at regular intervals", and eight sub-parameters of these parameters. For this purpose, this study evaluates the pilot implementation and effectiveness of the postoperative hypothermia management care bundle developed within the scope of the research. | Other | the pilot implementation and effectiveness of the postoperative hypothermia management care bundle |
Primary outcome
Care bundles compliance assessment form for postoperative hypothermia management
Time frame: 15 August 2025-28 February 2026
This form was developed by the researchers to evaluate the nurses' application of the care bundle to the patients. The boxes 'applied', 'not applied' if not applied, and 'not filled' if the control form is not marked will be ticked on the compliance assessment form in which the care bundle parameters are applied. Within the scope of this form, the compliance rate of the care bundle will be calculated. The rate found with this calculation will show the success of compliance with the maintenance bundle. In the calculation, the compliance rate will be calculated by dividing the number of patients to whom all parameters of the care bundle are fully implemented within the scope of the research by the number of patients to whom the care bundle parameters should be implemented. In this calculation, if the compliance rate is below 95%, it means that compliance with the care bundle is unsuccessful.
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 25 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
Zeliha OZDEMIR KOKEN, ASSOCIATE PROFESSOR study director
Hacettepe University Faculty of Nursing
Mustafa YILMAZ, PROFESSOR study chair
Hacettepe University Medicine Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postoperative Hypothermia Management Care Bundle in people with Postoperative Hypothermia, run by Hacettepe 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 7 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 25 Aug 2026. 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?
Care bundles compliance assessment form for postoperative hypothermia management (time frame: 15 August 2025-28 February 2026). 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 25 Aug 2026.