Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2026-01-07 @ 10:50 AM
Study NCT ID:
NCT03193905
Status:
COMPLETED
Last Update Posted:
2017-06-21
First Post:
2017-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preventing Inadvertent Hypothermia in Patients Undergoing Major Spinal Surgery
Sponsor:
Aalborg University Hospital
Organization:
Study Overview
Official Title:
Preventing Inadvertent Hypothermia in Patients Undergoing Major Spinal Surgery
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: