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Preventing Inadvertent Hypothermia in Patients Undergoing Major Spinal Surgery

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ClinicalTrials.gov Identifier: NCT03193905
Recruitment Status : Completed
First Posted : June 21, 2017
Last Update Posted : June 21, 2017
Sponsor:
Information provided by (Responsible Party):
Mia Nørgaard Granum, 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.


Condition or disease Intervention/treatment Phase
Hypothermia Following Anesthesia Neurosurgery Scoliosis Kyphosis Forced Air Warming Major Spinal Fusion Procedure: Bairhugger Full Access Underbody Blanket Procedure: Cotton blanket - control group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Preventing Inadvertent Hypothermia in Patients Undergoing Major Spinal Surgery
Study Start Date : November 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia

Arm Intervention/treatment
Cotton blanket
30 hypothermia patients undergo the standard procedure with a cotton blanket during major spinal surgery
Procedure: Cotton blanket - control group
30 patients undergo standard procedure with a cotton blanket

Bairhugger Full Access Underbody blanket
30 hypothermia patients undergo the Bairhugger Full Access Underbody blanket procedure during major spinal surgery (new procedure)
Procedure: Bairhugger Full Access Underbody Blanket
30 patients undergo new procedure with a Bairhugger Full Access Underbody Blanket




Primary Outcome Measures :
  1. Core temperature > 36 degrees Celsius [ Time Frame: Althrough completion of the study 5 months from now ]
    Core temperature at the start of surgery



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03193905


Sponsors and Collaborators
Aalborg University Hospital
Investigators
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Principal Investigator: Mia Nørgaard Granum Aalborg University Hospital

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Responsible Party: Mia Nørgaard Granum, Anaesthetic nurse, Aalborg University Hospital
ClinicalTrials.gov Identifier: NCT03193905     History of Changes
Other Study ID Numbers: BFAU blanket 2016
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: June 21, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Scoliosis
Kyphosis
Hypothermia
Body Temperature Changes
Signs and Symptoms
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases