Hypothermia Following AnesthesiaNCT03193905
Preventing Inadvertent Hypothermia in Patients Undergoing Major Spinal Surgery
A study testing Bairhugger Full Access Underbody Blanket in people with Hypothermia Following Anesthesia and Neurosurgery, run by Aalborg University Hospital.
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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Hypothermia Following Anesthesia, Neurosurgery, Scoliosis
- What is being tested?
- Bairhugger Full Access Underbody Blanket
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients for elective major spinal surgery
- Patients ≥ 14 years
- Danish language
Who cannot join
- 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
About this study
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.
Read more
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
- Being tested
- Bairhugger Full Access Underbody Blanket, Cotton blanket - control group
- Medical subject headings
- Scoliosis, Kyphosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bairhugger Full Access Underbody BlanketProcedure or surgery
30 patients undergo new procedure with a Bairhugger Full Access Underbody Blanket
Cotton blanket - control groupProcedure or surgery
30 patients undergo standard procedure with a cotton blanket
| Study group | Role | What they receive |
|---|---|---|
| Cotton blanket | Other | 30 hypothermia patients undergo the standard procedure with a cotton blanket during major spinal surgery Receives: 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) Receives: Procedure: Bairhugger Full Access Underbody Blanket |
What is being measured
The primary outcome is the main question the study is designed to answer.
Core temperature > 36 degrees Celsius
Core temperature at the start of surgery
Measured: Althrough completion of the study 5 months from now
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study startNov 2015
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypothermia Following AnesthesiaStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mia Nørgaard Granum, Aalborg University Hospital
- Investigators
- Mia Nørgaard Granum, Principal investigator, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03193905
- Sponsor's protocol ID
- BFAU blanket 2016
- Status last verified
- Jan 2017
- First submitted
- 11 Jan 2017
- Last updated
- 21 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Inadvertent Hypothermia in Patients Undergoing Major Spinal Surgery
- ClinicalTrials.gov ID
- NCT03193905
- Acronym / sponsor ID
- BFAU blanket 2016
- Conditions
- Hypothermia Following Anesthesia, Neurosurgery, Scoliosis, Kyphosis, Forced Air Warming, Major Spinal Fusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 21 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cotton blanket | Other | Procedure: Cotton blanket - control group30 hypothermia patients undergo the standard procedure with a cotton blanket during major spinal surgery |
| Bairhugger Full Access Underbody blanket | Other | Procedure: Bairhugger Full Access Underbody Blanket30 hypothermia patients undergo the Bairhugger Full Access Underbody blanket procedure during major spinal surgery (new procedure) |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients for elective major spinal surgery
- Patients ≥ 14 years
- Danish language
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bairhugger Full Access Underbody Blanket30 patients undergo new procedure with a Bairhugger Full Access Underbody Blanket | Procedure or surgery | Bairhugger Full Access Underbody blanket |
| Cotton blanket - control group30 patients undergo standard procedure with a cotton blanket | Procedure or surgery | Cotton blanket |
Primary outcome
Core temperature > 36 degrees Celsius
Time frame: Althrough completion of the study 5 months from now
Core temperature at the start of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mia Nørgaard Granum principal investigator
Aalborg University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Bairhugger Full Access Underbody Blanket in people with Hypothermia Following Anesthesia and Neurosurgery, run by Aalborg University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Core temperature > 36 degrees Celsius (time frame: Althrough completion of the study 5 months from now). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2017.