Hypothermia Following AnesthesiaNCT03790683
Intraoperative Warming During Major Surgical Procedures Using the Esophageal Temperature Management System
A study testing EnsoETM and Surface Warming in people with Hypothermia Following Anesthesia and Hypothermia, run by Advanced Cooling Therapy, Inc., d/b/a Attune Medical at 1 site in United States.
Trial summary
The aim of this study is to assess the effectiveness of EnsoETM as a supplemental warming device compared to the standard of care warming practice in patients having major surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypothermia Following Anesthesia, Hypothermia, Surgery
- What is being tested?
- EnsoETM and Surface Warming
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2019to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Provision of signed and dated informed consent form
- Male or female, ages 18 years and older
- Scheduled for major surgical procedures requiring general anesthesia and with no known contraindication to having an orogastric tube placed for the duration of the surgery
- The time in the OR is expected to last at least 180 minutes
Who cannot join
- Esophageal strictures (risk of perforation)
- Patients with known esophageal deformity or evidence of esophageal trauma (for example history of esophagectomy, previous swallowing disorders, achalasia, etc.)
- Known ingestion of acidic or caustic poisons within the prior 24 hours.
- Patients with <40 kg of body mass
- Coagulopathy
- Severe facial trauma
- Surgical procedures lasting less than 3 hours
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
The aim of this study is to assess the effectiveness of EnsoETM as a supplemental warming device compared to the standard of care warming practice in patients having major surgery.
Read the detailed description
Maintaining patient's body temperature is of major importance in patients undergoing surgical procedures and existing methods to warm patients to maintain perioperative normothermia have limitations. This results in as many as half of patients undergoing surgery developing inadvertent hypothermia during and/or after their procedure. The EnsoETM is an Esophageal Temperature Management (ETM) device consisting of a multi-chambered silicone tube connected to a heat exchanger and placed in the esophagus, providing highly efficient heat transfer to a patient. The EnsoETM potentially improves the ability to control patient temperature by eliminating the disadvantages of existing methods while maintaining the functionality of the orogastric tube that it replaces.
The primary objective of this study is to measure the number of degree-hours spent below 37°C intraoperatively and until recovery in the PACU. This measure will be compared between patients having standard management of body temperature to patients having the EnsoETM placed as an additional warming device.
- Conditions
- Hypothermia Following Anesthesia, Hypothermia, Surgery
- Being tested
- EnsoETM, Surface Warming
- Keywords
- intraoperative hypothermia, inadvertent hypothermia, perioperative hypothermia
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnsoETMDevice
Also called ECD02, Esophageal Cooling Device
Patients having major surgery will have the EnsoETM device placed after induction of general anesthesia. Addition of standard of care surface warming was specified as optional after first 7 patients.
Surface WarmingDevice
Also called Bair Hugger, forced air blanket
Forced air warming device will be placed on the patient according to standard practice.
| Study group | Role | What they receive |
|---|---|---|
| EnsoETM | Experimental | Participants receive esophageal warming. Original study design anticipated esophageal warming in addition to standard of care surface warming from the time they enter the OR until released to the PACU. After 7 patients, protocol was adjusted to specify only esophageal warming unless addition of surface warming was warranted. Receives: Device: EnsoETM; Device: Surface Warming |
| Standard of Care | Active comparator | Participants receive standard of care surface warming from the time they enter the OR until released to the PACU. Receives: Device: Surface Warming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inadvertent Hypothermia Prevention
Number of degree-hours spent below 37 °C intraoperatively until recovery in the PACU and return to 37°C body temperature.
Measured: Time from intubation until extubation, approximately 3-12 hours
Secondary outcomes (1)
Time From Intubation Until Extubation
Time from intubation until extubation
Measured: perioperative, approximately 3-12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2019
- Study start11 Feb 2019
- Primary completion1 Aug 2021
- Study completion1 Dec 2021
Why it stopped: Sponsor funding limitations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hypothermia Following 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, randomized interventional study
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advanced Cooling Therapy, Inc., d/b/a Attune Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Thomas Jefferson University
- Responsible party
- Sponsor
- Investigators
- Coleen Vernick, DO, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03790683
- Sponsor's protocol ID
- TJ Intraoperative warming
- Status last verified
- Jan 2023
- First submitted
- 27 Dec 2018
- Last updated
- 21 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Warming During Major Surgical Procedures Using the Esophageal Temperature Management System
- ClinicalTrials.gov ID
- NCT03790683
- Acronym / sponsor ID
- TJ Intraoperative warming
- Conditions
- Hypothermia Following Anesthesia, Hypothermia, Surgery
- Keywords
- intraoperative hypothermia, inadvertent hypothermia, perioperative hypothermia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor funding limitations
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Advanced Cooling Therapy, Inc., d/b/a Attune MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Thomas Jefferson University
- Study start
- 11 Feb 2019 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 2 Jan 2019 (actual)
- Results
- Posted 27 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to assess the effectiveness of EnsoETM as a supplemental warming device compared to the standard of care warming practice in patients having major surgery.
Detailed description
Maintaining patient's body temperature is of major importance in patients undergoing surgical procedures and existing methods to warm patients to maintain perioperative normothermia have limitations. This results in as many as half of patients undergoing surgery developing inadvertent hypothermia during and/or after their procedure. The EnsoETM is an Esophageal Temperature Management (ETM) device consisting of a multi-chambered silicone tube connected to a heat exchanger and placed in the esophagus, providing highly efficient heat transfer to a patient. The EnsoETM potentially improves the ability to control patient temperature by eliminating the disadvantages of existing methods while maintaining the functionality of the orogastric tube that it replaces.
The primary objective of this study is to measure the number of degree-hours spent below 37°C intraoperatively and until recovery in the PACU. This measure will be compared between patients having standard management of body temperature to patients having the EnsoETM placed as an additional warming device.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective, randomized interventional study
| Arm | Type | Receives |
|---|---|---|
| EnsoETM | Experimental | Device: EnsoETM, Device: Surface WarmingParticipants receive esophageal warming. Original study design anticipated esophageal warming in addition to standard of care surface warming from the time they enter the OR until released to the PACU. After 7 patients, protocol was adjusted to specify only esophageal warming unless addition of surface warming was warranted. |
| Standard of Care | Active comparator | Device: Surface WarmingParticipants receive standard of care surface warming from the time they enter the OR until released to the PACU. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Provision of signed and dated informed consent form
- Male or female, ages 18 years and older
- Scheduled for major surgical procedures requiring general anesthesia and with no known contraindication to having an orogastric tube placed for the duration of the surgery
- The time in the OR is expected to last at least 180 minutes
Key exclusion criteria (7 listed)
- Esophageal strictures (risk of perforation)
- Patients with known esophageal deformity or evidence of esophageal trauma (for example history of esophagectomy, previous swallowing disorders, achalasia, etc.)
- Known ingestion of acidic or caustic poisons within the prior 24 hours.
- Patients with <40 kg of body mass
- Coagulopathy
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 |
|---|---|---|
| EnsoETMAlso: ECD02, Esophageal Cooling DevicePatients having major surgery will have the EnsoETM device placed after induction of general anesthesia. Addition of standard of care surface warming was specified as optional after first 7 patients. | Device | EnsoETM |
| Surface WarmingAlso: Bair Hugger, forced air blanketForced air warming device will be placed on the patient according to standard practice. | Device | EnsoETM, Standard of Care |
Primary outcome
Inadvertent Hypothermia Prevention
Time frame: Time from intubation until extubation, approximately 3-12 hours
Number of degree-hours spent below 37 °C intraoperatively until recovery in the PACU and return to 37°C body temperature.
1 secondary outcome
Time From Intubation Until Extubation
Time frame: perioperative, approximately 3-12 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Coleen Vernick, DO principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EnsoETM and Surface Warming in people with Hypothermia Following Anesthesia and Hypothermia, run by Advanced Cooling Therapy, Inc., d/b/a Attune Medical at 1 site in United States.
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 7 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: stopped early, as of the sponsor's last update on 21 Feb 2023. 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 United States. 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?
Yes. Results are posted in the registry (first posted 27 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Inadvertent Hypothermia Prevention (time frame: Time from intubation until extubation, approximately 3-12 hours). 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 Feb 2023.