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
About this trial
This is an interventional prevention trial for Hypothermia Following Anesthesia
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
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
NCT ID
NCT03193905
First Posted
January 11, 2017
Last Updated
June 19, 2017
Sponsor
Aalborg University Hospital
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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