Preventing Inadvertent Hypothermia in Patients Undergoing Major Spinal Surgery

NCT03193905 | Completed

• 1 other identifier: BFAU blanket 2016
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypothermia Following Anesthesia; Neurosurgery; Scoliosis; Kyphosis; Forced Air Warming; Major Spinal Fusion

Outcome Measures

Primary Outcomes (1)

• Core temperature > 36 degrees Celsius

  Core temperature at the start of surgery

  Althrough completion of the study 5 months from now

Study Arms (2)

Cotton blanket

OTHER

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

Procedure: Cotton blanket - control group

Bairhugger Full Access Underbody blanket

OTHER

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

Procedure: Bairhugger Full Access Underbody Blanket

Interventions

Bairhugger Full Access Underbody Blanket PROCEDURE

30 patients undergo new procedure with a Bairhugger Full Access Underbody Blanket

Bairhugger Full Access Underbody blanket

Cotton blanket - control group PROCEDURE

30 patients undergo standard procedure with a cotton blanket

Cotton blanket

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aalborg University Hospital: lead

MeSH Terms

Conditions

Scoliosis; Kyphosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Mia Nørgaard Granum

  Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anaesthetic nurse

Study Record Dates

• First Submitted: January 11, 2017
• First Posted: June 21, 2017
• Study Start: November 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: June 21, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share