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| Name | Class |
|---|---|
| Thomas Jefferson University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Standard of Care | Active Comparator | Participants receive standard of care surface warming from the time they enter the OR until released to the PACU. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EnsoETM | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 from intubation until extubation, approximately 3-12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time From Intubation Until Extubation | Time from intubation until extubation | perioperative, approximately 3-12 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Coleen Vernick, DO | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Standard of Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | degrees Celsius*hours | Time from intubation until extubation, approximately 3-12 hours |
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During and up to 24 hours after surgery, a total of approximately 36 hours.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marc C. Torjman, Ph.D. | Sidney Kimmel Medical College, Thomas Jefferson University and Hospitals | (215) 955-5275 | Marc.Torjman@Jefferson.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 5, 2018 | Sep 6, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007035 | Hypothermia |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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prospective, randomized interventional study
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| Surface Warming | Device | Forced air warming device will be placed on the patient according to standard practice. |
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|
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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Time From Intubation Until Extubation | Time from intubation until extubation | Data were not collected and the outcome cannot be reported. | Posted | perioperative, approximately 3-12 hours |
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| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | 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. | 0 | 14 | 0 | 14 | 0 | 14 |
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