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Preventing Inadvertent Hypothermia in Patients Undergoing Major Spinal Surgery

Primary Purpose

Hypothermia Following Anesthesia, Neurosurgery, Scoliosis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bairhugger Full Access Underbody Blanket
Cotton blanket - control group
Sponsored by
Aalborg University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypothermia Following Anesthesia

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients for elective major spinal surgery
  • Patients ≥ 14 years
  • Danish language

Exclusion Criteria:

  • Patients> 110 kg
  • Patients with a temperature > 37.5 ° C
  • Patients with a temperature ≤ 35 ° C
  • Cognitive impairment to such an extent that the patient does not understand the purpose of, nor is able to cooperate, with the project

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Cotton blanket

    Bairhugger Full Access Underbody blanket

    Arm Description

    30 hypothermia patients undergo the standard procedure with a cotton blanket during major spinal surgery

    30 hypothermia patients undergo the Bairhugger Full Access Underbody blanket procedure during major spinal surgery (new procedure)

    Outcomes

    Primary Outcome Measures

    Core temperature > 36 degrees Celsius
    Core temperature at the start of surgery

    Secondary Outcome Measures

    Full Information

    First Posted
    January 11, 2017
    Last Updated
    June 19, 2017
    Sponsor
    Aalborg University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03193905
    Brief Title
    Preventing Inadvertent Hypothermia in Patients Undergoing Major Spinal Surgery
    Official Title
    Preventing Inadvertent Hypothermia in Patients Undergoing Major Spinal Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2015 (undefined)
    Primary Completion Date
    November 2016 (Actual)
    Study Completion Date
    November 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Aalborg University Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Background Major spinal surgery tend to be lengthy with an increased risk of hypothermia. A quality improvement project of patients undergoing major spinal surgery showed that 67 % were hypothermic at the beginning of surgery. Several patients expressed a feeling of coldness at the arrival of the operating theatre. Aim To evaluate if Bairhuggers Full Access Underbody blanket can prevent hypothermia at initiation if used as prewarming and intraoperative warming compared to the results from the local quality improvement project. In addition we aim to explore patients´ experiences of comfort in relation to their temperature. Method Temperature of patients undergoing major spinal surgery (n=30) will be assessed at arrival to the theatre, after insertion of bladder catheter, at the start and end of surgery using a bladder temperature. The patients´ experiences of comfort will be evaluated with a 5 point Likert at the arrival to the operating theatre and after ten minutes of active prewarming with Bairhuggers Full Access Underbody blanket. Preoperatively ten randomly chosen patients will be observed and later interviewed in order to obtain further information regarding their experiences of comfort in relation to their temperature. Conclusion and perspectives By increasing the investigators knowledge on Bairhuggers Full Access Underbody blanket and its effects in preventing hypothermia as well as gaining insight to patients´ experiences of comfort in relation to temperature, the investigators anticipate to improve pre-anesthetic care and minimize risk factors associated with hypothermia for patients undergoing major spinal surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypothermia Following Anesthesia, Neurosurgery, Scoliosis, Kyphosis, Forced Air Warming, Major Spinal Fusion

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cotton blanket
    Arm Type
    Other
    Arm Description
    30 hypothermia patients undergo the standard procedure with a cotton blanket during major spinal surgery
    Arm Title
    Bairhugger Full Access Underbody blanket
    Arm Type
    Other
    Arm Description
    30 hypothermia patients undergo the Bairhugger Full Access Underbody blanket procedure during major spinal surgery (new procedure)
    Intervention Type
    Procedure
    Intervention Name(s)
    Bairhugger Full Access Underbody Blanket
    Intervention Description
    30 patients undergo new procedure with a Bairhugger Full Access Underbody Blanket
    Intervention Type
    Procedure
    Intervention Name(s)
    Cotton blanket - control group
    Intervention Description
    30 patients undergo standard procedure with a cotton blanket
    Primary Outcome Measure Information:
    Title
    Core temperature > 36 degrees Celsius
    Description
    Core temperature at the start of surgery
    Time Frame
    Althrough completion of the study 5 months from now

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    14 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients for elective major spinal surgery Patients ≥ 14 years Danish language Exclusion Criteria: Patients> 110 kg Patients with a temperature > 37.5 ° C Patients with a temperature ≤ 35 ° C Cognitive impairment to such an extent that the patient does not understand the purpose of, nor is able to cooperate, with the project
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mia Nørgaard Granum
    Organizational Affiliation
    Aalborg University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Preventing Inadvertent Hypothermia in Patients Undergoing Major Spinal Surgery

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