Perioperative/Postoperative ComplicationsNCT03163563
Perioperative Hypothermia Hypothermia in Ambulatory Surgery
An observational study of Perioperative/Postoperative Complications, run by Aleris Helse at 1 site in Norway.
Trial summary
The purpose of the study is to measure patient- temperature in the perioperative period of patients undergoing plastic surgery in an ambulatory surgical unit. This study will evaluate if active warming with self-warming blanket (Easywarm®) is as effective as active warming with forced-air blanket (BairHugger®). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perioperative/Postoperative Complications
- What is being tested?
- Easywarm and BairHugger
- Type of treatment
- Medical device
- How many people
- 112 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2016to Jun 2016
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients planned for plastic surgery with planned total anestesia for more than 60 minutes are enrolled consecutively.
Who may be able to join
- Patients for planned plastic surgery with duration of general anesthesia ≥ 60 minutes.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perioperative Hypothermia Hypothermia in Ambulatory Surgery by Self-warming or Forced-air Warming Blanket, a Randomised Controlled Trial
The purpose of the study is to measure patient- temperature in the perioperative period of patients undergoing plastic surgery in an ambulatory surgical unit. This study will evaluate if active warming with self-warming blanket (Easywarm®) is as effective as active warming with forced-air blanket (BairHugger®). Second the study will evaluate if one or both methods is effective in preventing perioperative hypothermia.
Read the detailed description
Background:
Anesthesia medicaments given in general anesthesia cause impaired thermoregulation and thermogenesis. After induction of general anesthesia the core temperature is reduced to redistribution of blood from the body core to the cooler skin. Later impaired thermogenesis contributes to further loss of heat.
Mild hypothermia (<36 degrees Celsius) contributes to increased incidence of wound infections, prolonged stay in the post anesthesia care unit, shivering and reduced patient comfort.
There are several effective interventions to prevent hypothermia such as active warming pre-, per- and postoperatively. Preheated intravenous fluids and medical interventions to alter the blood distribution from the periphery to the body core have been effective in preventing hypothermia.
In the department both self-warming blanket (Easywarm®) and forced-air blanket (BairHugger®) are routinely used to prevent hypothermia. It has been observed that a few patients undergoing plastic surgery with anesthesia time more than one hour are shivering and feeling cold in the postoperative period.
Purpose:
The purpose of the study is to observe and measure patient- temperature in the perioperative period of patients undergoing plastic surgery in an ambulatory surgical unit. This study will evaluate if active warming with self-warming blanket (Easywarm®) is as effective as active warming with forced-air blanket (BairHugger®). Second the study will evaluate if one or both methods is effective in preventing perioperative hypothermia.
Design:
The is a quality assurance study deigned as a prospective randomised trial. With a validated non-invasive termometer (SpotOn® 3M) temperature is measured before, during and after surgical procedures in general anesthesia. An equal number of notes with the number 1 and 2 were put into an envelope (1=EasyWarm®, 2=BairHugger®). For each operation theater a note is drawn, and all patients in that operation theater receives active warming according to the number on the note.
Population data:
Sex, age , weight, height, BMI, medication, morbidities and ASA class will be registered.
Measurements:
- temperature (Celsius)
- Blood pressure
- Heartrate
- SaO2
- Temperature-comfort "numeric rating scale" (NRS)
Other registrations:
- Medicines given during the study period.
- Start and end of anesthesia and surgery
- Time when temperature is above or eual to 36 degrees Celsius.
- Time when the patient go home
Data is collected and registered on a dataform. Data are analysed in a anonymized excel workbook.
- Being tested
- Easywarm, BairHugger
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EasywarmDevice
Warming blanket
BairHuggerDevice
Patient warming mattress with continuous warm air.
| Study group | Role | What they receive |
|---|---|---|
| Easywarm | Self warming blanket to prevent perioperative hypothermia Receives: Device: Easywarm | |
| BairHugger | Forced-air warming blanket to prevent perioperative hypothermia Receives: Device: BairHugger |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temperature
Temperature Celsius measured by SpotOn 3M
Measured: Perioperative period
Secondary outcomes (2)
Medication given during study period
Type and dosage is registered. Ephedrine and phenylephrine are known to interact with temperature regulation.
Measured: Perioperative period
Temperature Numerical Rating Scale
To identify at which temperature the patient is comfortably warm without need for warming intervention.
Measured: Perioperative period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2017
- Study startMar 2016
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perioperative/Postoperative ComplicationsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aleris Helse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stig S Tyvold, MD PhD, Principal investigator, Aleris Helse AS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03163563
- Sponsor's protocol ID
- 2015/1481
- Status last verified
- May 2017
- First submitted
- 2 Mar 2016
- Last updated
- 23 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tyvold SS. Preventing hypothermia in outpatient plastic surgery by self-warming or forced-air-warming blanket: A randomised controlled trial. Eur J Anaesthesiol. 2019 Nov;36(11):843-850. doi: 10.1097/EJA.0000000000001087.
PubMed 31567576
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Hypothermia Hypothermia in Ambulatory Surgery by Self-warming or Forced-air Warming Blanket, a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03163563
- Acronym / sponsor ID
- 2015/1481
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Aleris HelseUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 23 May 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.
The purpose of the study is to measure patient- temperature in the perioperative period of patients undergoing plastic surgery in an ambulatory surgical unit. This study will evaluate if active warming with self-warming blanket (Easywarm®) is as effective as active warming with forced-air blanket (BairHugger®). Second the study will evaluate if one or both methods is effective in preventing perioperative hypothermia.
Detailed description
Background:
Anesthesia medicaments given in general anesthesia cause impaired thermoregulation and thermogenesis. After induction of general anesthesia the core temperature is reduced to redistribution of blood from the body core to the cooler skin. Later impaired thermogenesis contributes to further loss of heat.
Mild hypothermia (<36 degrees Celsius) contributes to increased incidence of wound infections, prolonged stay in the post anesthesia care unit, shivering and reduced patient comfort.
There are several effective interventions to prevent hypothermia such as active warming pre-, per- and postoperatively. Preheated intravenous fluids and medical interventions to alter the blood distribution from the periphery to the body core have been effective in preventing hypothermia.
In the department both self-warming blanket (Easywarm®) and forced-air blanket (BairHugger®) are routinely used to prevent hypothermia. It has been observed that a few patients undergoing plastic surgery with anesthesia time more than one hour are shivering and feeling cold in the postoperative period.
Purpose:
The purpose of the study is to observe and measure patient- temperature in the perioperative period of patients undergoing plastic surgery in an ambulatory surgical unit. This study will evaluate if active warming with self-warming blanket (Easywarm®) is as effective as active warming with forced-air blanket (BairHugger®). Second the study will evaluate if one or both methods is effective in preventing perioperative hypothermia.
Design:
The is a quality assurance study deigned as a prospective randomised trial. With a validated non-invasive termometer (SpotOn® 3M) temperature is measured before, during and after surgical procedures in general anesthesia. An equal number of notes with the number 1 and 2 were put into an envelope (1=EasyWarm®, 2=BairHugger®). For each operation theater a note is drawn, and all patients in that operation theater receives active warming according to the number on the note.
Population data:
Sex, age , weight, height, BMI, medication, morbidities and ASA class will be registered.
Measurements:
- temperature (Celsius)
- Blood pressure
- Heartrate
- SaO2
- Temperature-comfort "numeric rating scale" (NRS)
Other registrations:
- Medicines given during the study period.
- Start and end of anesthesia and surgery
- Time when temperature is above or eual to 36 degrees Celsius.
- Time when the patient go home
Data is collected and registered on a dataform. Data are analysed in a anonymized excel workbook.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Easywarm | – | Device: EasywarmSelf warming blanket to prevent perioperative hypothermia |
| BairHugger | – | Device: BairHuggerForced-air warming blanket to prevent perioperative hypothermia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients planned for plastic surgery with planned total anestesia for more than 60 minutes are enrolled consecutively.
Key inclusion criteria (1 listed)
- Patients for planned plastic surgery with duration of general anesthesia ≥ 60 minutes.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| EasywarmWarming blanket | Device | Easywarm |
| BairHuggerPatient warming mattress with continuous warm air. | Device | BairHugger |
Primary outcome
Temperature
Time frame: Perioperative period
Temperature Celsius measured by SpotOn 3M
2 secondary outcomes
Medication given during study period
Time frame: Perioperative period
Temperature Numerical Rating Scale
Time frame: Perioperative period.
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 23 May 2017.
- Derived from this study: PubMed 31567576Tyvold SS. Preventing hypothermia in outpatient plastic surgery by self-warming or forced-air-warming blanket: A randomised controlled trial. Eur J Anaesthesiol. 2019 Nov;36(11):843-850. doi: 10.1097/EJA.0000000000001087.
- 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.
Stig S Tyvold, MD PhD principal investigator
Aleris Helse AS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perioperative/Postoperative Complications, run by Aleris Helse at 1 site in Norway.
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 1 inclusion and 1 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 23 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Temperature (time frame: Perioperative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03163563, which also lists 1 linked publication.
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 23 May 2017.