Preventing Inadvertent Hypothermia in Patients Undergoing Major Spinal Surgery

Study Overview
=================
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.

Official Title
-----------------
Preventing Inadvertent Hypothermia in Patients Undergoing Major Spinal Surgery

Conditions
-----------------
Hypothermia Following Anesthesia, Neurosurgery, Scoliosis, Kyphosis, Forced Air Warming, Major Spinal Fusion

Intervention / Treatment
-----------------
* Procedure: Bairhugger Full Access Underbody Blanket
* Procedure: Cotton blanket - control group


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 14 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cotton blanket<br>30 hypothermia patients undergo the standard procedure with a cotton blanket during major spinal surgery | Procedure: Cotton blanket - control group<br>* 30 patients undergo standard procedure with a cotton blanket<br>|
| Other: Bairhugger Full Access Underbody blanket<br>30 hypothermia patients undergo the Bairhugger Full Access Underbody blanket procedure during major spinal surgery (new procedure) | Procedure: Bairhugger Full Access Underbody Blanket<br>* 30 patients undergo new procedure with a Bairhugger Full Access Underbody Blanket<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Core temperature > 36 degrees Celsius | Core temperature at the start of surgery | Althrough completion of the study 5 months from now |