Preventing Inadvertent Hypothermia in Patients Undergoing Major Spinal Surgery

Not Applicable

Completed

• Conditions: Neurosurgery; Forced Air Warming; Hypothermia Following Anesthesia; Scoliosis; Kyphosis; Major Spinal Fusion
• Interventions: Procedure: Cotton blanket - control group; Procedure: Bairhugger Full Access Underbody Blanket

• Registration Number: NCT03193905
• Lead Sponsor: Aalborg University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2017-01
• Study First Submitted: 2017-01-11
• Study First Submitted QC: 2017-06-19
• Last Update Submitted: 2017-06-19
• Study First Posted: 2017-06-21
• Last Update Posted: 2017-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cotton blanket	Cotton blanket - control group	30 hypothermia patients undergo the standard procedure with a cotton blanket during major spinal surgery
Bairhugger Full Access Underbody blanket	Bairhugger Full Access Underbody Blanket	30 hypothermia patients undergo the Bairhugger Full Access Underbody blanket procedure during major spinal surgery (new procedure)

Primary Outcome Measures

Name	Time	Method
Core temperature > 36 degrees Celsius	Althrough completion of the study 5 months from now	Core temperature at the start of surgery