Pilot Implementation of the Postoperative Hypothermia Management Care Bundle

NCT06829017 | Not Yet Recruiting DMC

• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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, 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.

Conditions

Postoperative Hypothermia

Keywords

postoperative hypothermia; care bundle; nursing; surgery; postoperative care

Outcome Measures

Primary Outcomes (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.

  15 August 2025-28 February 2026

Study Arms (1)

the pilot implementation and effectiveness of the postoperative hypothermia management care bundle

OTHER

Other: Postoperative Hypothermia Management Care Bundle

Interventions

Postoperative Hypothermia Management Care Bundle OTHER

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.

the pilot implementation and effectiveness of the postoperative hypothermia management care bundle

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University adult hospital

Ankara, ABD Veya Kanada'daysanız Lütfen Seçin..., 06230, Turkey (Türkiye)

Location

Study Officials

• Zeliha OZDEMIR KOKEN, ASSOCIATE PROFESSOR

  Hacettepe University Faculty of Nursing

  STUDY DIRECTOR

• Mustafa YILMAZ, PROFESSOR

  Hacettepe University Medicine Faculty

  STUDY CHAIR

Central Study Contacts

Ali BALKAN, PhD candidate

CONTACT

+90(545) 201 13 25; alibalkann02@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant

Study Record Dates

• First Submitted: February 9, 2025
• First Posted: February 17, 2025
• Study Start: August 15, 2025
• Primary Completion: February 15, 2026
• Study Completion: March 31, 2026
• Last Updated: July 25, 2025

Record last verified: 2025-07

Locations

TU (1)