Trial Outcomes & Findings for Intraoperative Warming During Major Surgical Procedures Using the Esophageal Temperature Management System (NCT NCT03790683)
NCT ID: NCT03790683
Last Updated: 2023-02-21
Results Overview
Number of degree-hours spent below 37 °C intraoperatively until recovery in the PACU and return to 37°C body temperature.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
28 participants
Primary outcome timeframe
Time from intubation until extubation, approximately 3-12 hours
Results posted on
2023-02-21
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
14
|
|
Overall Study
COMPLETED
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
EnsoETM
n=14 Participants
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.
|
Standard of Care
n=14 Participants
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.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=28 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=14 Participants
|
7 Participants
n=14 Participants
|
16 Participants
n=28 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=14 Participants
|
7 Participants
n=14 Participants
|
12 Participants
n=28 Participants
|
|
Age, Continuous
|
58.4 Years
STANDARD_DEVIATION 14.3 • n=14 Participants
|
65.4 Years
STANDARD_DEVIATION 7.4 • n=14 Participants
|
61.9 Years
STANDARD_DEVIATION 11.7 • n=28 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=14 Participants
|
6 Participants
n=14 Participants
|
13 Participants
n=28 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=14 Participants
|
8 Participants
n=14 Participants
|
15 Participants
n=28 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
14 participants
n=14 Participants
|
14 participants
n=14 Participants
|
28 participants
n=28 Participants
|
PRIMARY outcome
Timeframe: Time from intubation until extubation, approximately 3-12 hoursNumber of degree-hours spent below 37 °C intraoperatively until recovery in the PACU and return to 37°C body temperature.
Outcome measures
| Measure |
EnsoETM
n=14 Participants
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.
|
Standard of Care
n=14 Participants
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.
|
|---|---|---|
|
Inadvertent Hypothermia Prevention
|
5.85 degrees Celsius*hours
Standard Deviation .36
|
4.25 degrees Celsius*hours
Standard Deviation .41
|
SECONDARY outcome
Timeframe: perioperative, approximately 3-12 hoursPopulation: Data were not collected and the outcome cannot be reported.
Time from intubation until extubation
Outcome measures
Outcome data not reported
Adverse Events
EnsoETM
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Marc C. Torjman, Ph.D.
Sidney Kimmel Medical College, Thomas Jefferson University and Hospitals
Phone: (215) 955-5275
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place