Preventing Inadvertent Hypothermia in Patients Undergoing Major Spinal Surgery

Scoliosis Clinical Trial

Official title:

Preventing Inadvertent Hypothermia in Patients Undergoing Major Spinal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03193905
• Other study ID #: BFAU blanket 2016
• Status: Completed
• Phase: N/A
• First received: January 11, 2017
• Last updated: June 19, 2017
• Start date: November 2015
• Est. completion date: November 2016

Study information

• Verified date: January 2017
• Source: Aalborg Universitetshospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Bairhugger Full Access Underbody Blanket
30 patients undergo new procedure with a Bairhugger Full Access Underbody Blanket
• Cotton blanket - control group
30 patients undergo standard procedure with a cotton blanket

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg Universitetshospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Core temperature > 36 degrees Celsius	Core temperature at the start of surgery	Althrough completion of the study 5 months from now