Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 30000000064) | Other Identifier | Vyaire Medical |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Helsinki University Central Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
This study is part of a post-market clinical follow-up (PMCF). The purpose of this study is to verify in a routine clinical environment with a number of caregivers and subjects that the enFlow performs as intended when used as an element of maintaining acceptable core temperatures.
Eligible subjects from the study will be recruited from patients with scheduled surgeries. After being informed about the study and potential risks, patients given informed consent will undergo scheduled surgery with the use of enFlow IV Fluid and Blood Warming System. The following temperature measurements will be collected during surgery:
Temperature will be measured and collected post-surgery upon arrival to the PACU and 30 minutes post-arrival.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 60 minute surgery | Patients completing at least 60 minutes of surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enFlow IV Fluid and Blood Warming System | Device | The enFlow IV fluid/blood warming system's intended use is for warming blood, blood products and intravenous solutions prior to administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Maintenance of intraoperative core temperature | Core temperature is defined as the highest temperature reading during 30 seconds made within 5 minutes of protocol time. The primary outcome measure will be the mean of the temperature measurements taken during the course of surgery | 15 and 30 minutes post-induction, then every 30 minutes untl the termination of the scheduled surgical procedure, and a final measurement recorded at the time of termination of the scheduled surgical procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Core temperature for two periods | The mean of the measurements taken during the Induction period and during the Post-Induction period. | Induction: first 90 minutes. Post-Induction: after 90 minutes until the end of surgery, |
| Number of hypothermic events |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Subjects from the study will be recruited from patients with scheduled surgeries. Most are expected to be inpatient due to the exclusion of short surgeries. For this study, only adults will be enrolled. Participation will also be limited to patients fluent in the language(s) of the information and consent form.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mikko Lax, MD | Helsinki and Uusimaa Hospital District, Helsinki University Hospital | Principal Investigator |
| Seppo Mustola, MD, PhD | South Karelia Central Hospital (EKSOTE, ALTEK), Dept. of Anesthesiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki and Uusimaa Hospital District, Helsinki University Hospital | Helsinki | 00029 HUS | Finland | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25866139 | Background | Campbell G, Alderson P, Smith AF, Warttig S. Warming of intravenous and irrigation fluids for preventing inadvertent perioperative hypothermia. Cochrane Database Syst Rev. 2015 Apr 13;2015(4):CD009891. doi: 10.1002/14651858.CD009891.pub2. | |
| Background | National Institute of Health and Care Excellence (NICE). Hypothermia: prevention and management in adults having surgery Clinical guideline. Original Published: 23 April 2008. nice.org.uk/guidance/cg65 2019 | ||
| 30467673 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007035 | Hypothermia |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
The incidence and duration of hypothermic events (<36.0C). |
| During 30 seconds made within 5 minutes of protocol time |
| Number of hyperthermic events | The incidence and duration of hyperthermic events (>38.0 oC). | During 30 seconds made within 5 minutes of protocol time |
| Incidence of infusate outside acceptable operating range (i.e., device "green range") | Device reading 35-42 oC | Induction: first 90 minutes. Post-Induction: after 90 minutes until the end of surgery, |
| South Karelia Central Hospital (EKSOTE, ALTEK) |
| Lappeenranta |
| 53130 |
| Finland |
| Background |
| Pesonen E, Silvasti-Lundell M, Niemi TT, Kivisaari R, Hernesniemi J, Makinen MT. The focus of temperature monitoring with zero-heat-flux technology (3M Bair-Hugger): a clinical study with patients undergoing craniotomy. J Clin Monit Comput. 2019 Oct;33(5):917-923. doi: 10.1007/s10877-018-0227-z. Epub 2018 Nov 22. |
| 27521967 | Background | Makinen MT, Pesonen A, Jousela I, Paivarinta J, Poikajarvi S, Alback A, Salminen US, Pesonen E. Novel Zero-Heat-Flux Deep Body Temperature Measurement in Lower Extremity Vascular and Cardiac Surgery. J Cardiothorac Vasc Anesth. 2016 Aug;30(4):973-8. doi: 10.1053/j.jvca.2016.03.141. Epub 2016 Mar 22. |