Hypothermia, Hypothermia Following Anesthesia, Surgery
Conditions
Keywords
intraoperative hypothermia, inadvertent hypothermia, perioperative hypothermia
Brief 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.
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.
Interventions
DEVICEEnsoETM
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.
DEVICESurface Warming
Forced air warming device will be placed on the patient according to standard practice.
Sponsors
Thomas Jefferson University
Advanced Cooling Therapy, Inc., d/b/a Attune Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
prospective, randomized interventional study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inadvertent Hypothermia Prevention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time From Intubation Until Extubation | perioperative, approximately 3-12 hours | Time from intubation until extubation |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| EnsoETM Participants receive esophageal warming only from the time they enter the OR until released to the PACU.
EnsoETM: Patients having major surgery will have the EnsoETM device placed after induction of general anesthesia. | 14 |
| Standard of Care Participants receive standard of care surface warming from the time they enter the OR until released to the PACU.
Surface Warming: Forced air warming device will be placed on the patient according to standard practice. | 14 |
| Total | 28 |
Baseline characteristics
| Characteristic | Standard of Care | Total | EnsoETM |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 12 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 16 Participants | 9 Participants |
| Age, Continuous | 65.4 Years STANDARD_DEVIATION 7.4 | 61.9 Years STANDARD_DEVIATION 11.7 | 58.4 Years STANDARD_DEVIATION 14.3 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 14 participants | 28 participants | 14 participants |
| Sex: Female, Male Female | 6 Participants | 13 Participants | 7 Participants |
| Sex: Female, Male Male | 8 Participants | 15 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 14 |
| other Total, other adverse events | 0 / 14 | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 |
Outcome results
Primary
Inadvertent Hypothermia Prevention
Number of degree-hours spent below 37 °C intraoperatively until recovery in the PACU and return to 37°C body temperature.
Time frame: Time from intubation until extubation, approximately 3-12 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EnsoETM | Inadvertent Hypothermia Prevention | 5.85 degrees Celsius*hours | Standard Deviation 0.36 |
| Standard of Care | Inadvertent Hypothermia Prevention | 4.25 degrees Celsius*hours | Standard Deviation 0.41 |
Secondary
Time From Intubation Until Extubation
Time from intubation until extubation
Time frame: perioperative, approximately 3-12 hours
Population: Data were not collected and the outcome cannot be reported.