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Pilot Implementation of the Postoperative Hypothermia Management Care Bundle

NCT06829017 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-07-25

No results posted yet for this study

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

Interventions

OTHER

Postoperative Hypothermia Management Care Bundle

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.

Sponsors & Collaborators

  • Hacettepe University

    lead OTHER

Principal Investigators

  • Zeliha OZDEMIR KOKEN, ASSOCIATE PROFESSOR · Hacettepe University Faculty of Nursing

  • Mustafa YILMAZ, PROFESSOR · Hacettepe University Medicine Faculty

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-15
Primary Completion
2026-02-15
Completion
2026-03-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06829017 on ClinicalTrials.gov