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Completed

NCT Number: NCT03193905

Preventing Inadvertent Hypothermia in Patients Undergoing Major Spinal Surgery

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.

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Key information

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bairhugger Full Access Underbody Blanket

Procedure

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

Cotton blanket - control group

Procedure

30 patients undergo standard procedure with a cotton blanket

Primary outcomes

  1. Core temperature > 36 degrees Celsius

    Time frame: Althrough completion of the study 5 months from now

    Core temperature at the start of surgery

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 21, 2017
Registry last updated
Jun 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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