Hypothermia; AnesthesiaNCT04709627
enFlow IV Fluid and Blood Warming System
An observational study of Hypothermia; Anesthesia, run by Vyaire Medical at 2 sites in Finland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypothermia; Anesthesia
- What is being tested?
- enFlow IV Fluid and Blood Warming System
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 50 participants
- Where
- 2 sitesFinland
- Study dates
- 6 Jul 2021to 23 Feb 2022
- 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: 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.
Who may be able to join
- 18 years of age or older
- Patients requiring surgery expected to last at least 1 hour.
- Expectation of the perioperative need for at least one liter of infused fluids warmed during infusion
- Informed Consent
Who cannot join
- Recent history of fever (>38 C, within 24 hours of surgery)
- Active infection
- Pregnant women
- Terminal illness (<30 days)
- Intended use of cardiopulmonary bypass
- Clinical intention for perioperative cooling and hypothermia
- unavailability of esophageal measurement during surgery
- Attending physician does not believe participation of the patient is in their best interest.
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
Helsinki and Uusimaa Hospital District, Helsinki University Hospital
Helsinki, 00029 HUS
South Karelia Central Hospital (EKSOTE, ALTEK)
Lappeenranta, 53130
About this study
Official title: Verification of Clinical Utility: enFlow IV Fluid and Blood Warming System
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.
Read the detailed description
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:
- Baseline temperature measurement (0-15 minutes prior to induction)
- Induction temperature measurements (15 minutes, 30 minutes, 60 minutes, 90 minute post-induction)
- Continued temperature measurements (every 30 minutes, plus end of surgery)
- OR ambient temperature at induction and end of surgery.
Temperature will be measured and collected post-surgery upon arrival to the PACU and 30 minutes post-arrival.
- Conditions
- Hypothermia; Anesthesia
- Being tested
- enFlow IV Fluid and Blood Warming System
- Keywords
- Surgery
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enFlow IV Fluid and Blood Warming SystemDevice
The enFlow IV fluid/blood warming system's intended use is for warming blood, blood products and intravenous solutions prior to administration.
| Study group | Role | What they receive |
|---|---|---|
| 60 minute surgery | Patients completing at least 60 minutes of surgery Receives: Device: enFlow IV Fluid and Blood Warming System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Secondary outcomes (4)
Core temperature for two periods
The mean of the measurements taken during the Induction period and during the Post-Induction period.
Measured: Induction: first 90 minutes. Post-Induction: after 90 minutes until the end of surgery,
Number of hypothermic events
The incidence and duration of hypothermic events (<36.0C).
Measured: During 30 seconds made within 5 minutes of protocol time
Number of hyperthermic events
The incidence and duration of hyperthermic events (>38.0 oC).
Measured: 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
Measured: Induction: first 90 minutes. Post-Induction: after 90 minutes until the end of surgery,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start6 Jul 2021
- Primary completion23 Feb 2022
- Study completion23 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hypothermia; AnesthesiaStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vyaire Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Helsinki University Central Hospital
- Responsible party
- Sponsor
- Investigators
- Mikko Lax, MD, Principal investigator, Helsinki and Uusimaa Hospital District, Helsinki University HospitalSeppo Mustola, MD, PhD, Principal investigator, South Karelia Central Hospital (EKSOTE, ALTEK), Dept. of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04709627
- Sponsor's protocol ID
- 100-P0093
- Other IDs
- 30000000064)
- Status last verified
- Jun 2022
- First submitted
- 8 Jan 2021
- Last updated
- 1 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 25866139National 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
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.
PubMed 30467673Makinen 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.
PubMed 27521967
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Verification of Clinical Utility: enFlow IV Fluid and Blood Warming System
- ClinicalTrials.gov ID
- NCT04709627
- Acronym / sponsor ID
- 100-P0093
- Conditions
- Hypothermia; Anesthesia
- Keywords
- Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Vyaire MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Helsinki University Central Hospital
- Study start
- 6 Jul 2021 (actual)
- Primary completion
- 23 Feb 2022 (actual)
- Study completion
- 23 Feb 2022 (actual)
- First posted
- 14 Jan 2021 (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.
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.
Detailed description
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:
- Baseline temperature measurement (0-15 minutes prior to induction)
- Induction temperature measurements (15 minutes, 30 minutes, 60 minutes, 90 minute post-induction)
- Continued temperature measurements (every 30 minutes, plus end of surgery)
- OR ambient temperature at induction and end of surgery.
Temperature will be measured and collected post-surgery upon arrival to the PACU and 30 minutes post-arrival.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 60 minute surgery | – | Device: enFlow IV Fluid and Blood Warming SystemPatients completing at least 60 minutes of surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 18 years of age or older
- Patients requiring surgery expected to last at least 1 hour.
- Expectation of the perioperative need for at least one liter of infused fluids warmed during infusion
- Informed Consent
Key exclusion criteria (8 listed)
- Recent history of fever (>38 C, within 24 hours of surgery)
- Active infection
- Pregnant women
- Terminal illness (<30 days)
- Intended use of cardiopulmonary bypass
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 |
|---|---|---|
| enFlow IV Fluid and Blood Warming SystemThe enFlow IV fluid/blood warming system's intended use is for warming blood, blood products and intravenous solutions prior to administration. | Device | 60 minute surgery |
Primary outcome
Maintenance of intraoperative core temperature
Time frame: 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.
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
4 secondary outcomes
Core temperature for two periods
Time frame: Induction: first 90 minutes. Post-Induction: after 90 minutes until the end of surgery,
Number of hypothermic events
Time frame: During 30 seconds made within 5 minutes of protocol time
Number of hyperthermic events
Time frame: During 30 seconds made within 5 minutes of protocol time
Incidence of infusate outside acceptable operating range (i.e., device "green range")
Time frame: Induction: first 90 minutes. Post-Induction: after 90 minutes until the end 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 1 Jul 2022.
- Background: PubMed 25866139Campbell 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.
- BackgroundNational 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
- Background: PubMed 30467673Pesonen 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.
- Background: PubMed 27521967Makinen 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.
- 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.
Mikko Lax, MD principal investigator
Helsinki and Uusimaa Hospital District, Helsinki University Hospital
Seppo Mustola, MD, PhD principal investigator
South Karelia Central Hospital (EKSOTE, ALTEK), Dept. of Anesthesiology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypothermia; Anesthesia, run by Vyaire Medical at 2 sites in Finland.
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 4 inclusion and 8 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 1 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. 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?
Maintenance of intraoperative core temperature (time frame: 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.). 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 NCT04709627, which also lists 4 linked publications.
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 1 Jul 2022.