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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Turkey (Türkiye)

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

  1. Nurse Descriptive Information Form
  2. Postoperative Hypothermia Management Care Bundle Checklist
  3. Compliance Assessment Form
  4. Semi-structured Questionnaire for Nurses
  5. 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.

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 groups in NCT06829017
Study groupRoleWhat they receive
the pilot implementation and effectiveness of the postoperative hypothermia management care bundleOtherNot 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.

  1. 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.

  1. First posted17 Feb 2025
  2. Study start1 Jan 2026
  3. Primary completion20 Jun 2026
  4. Study completion30 Jun 2026

Resources

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)
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

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.

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