Trial Outcomes & Findings for Evaluating Adult Patient Temperatures During Lower Spinal Surgery (NCT NCT03050775)

Last Updated: 2018-05-07

Results Overview

Core body temperature will be taken in the esophagus. The last recorded esophageal temperature will be used for surgeries not reaching 3 hours duration.

Recruitment status

COMPLETED

Study phase

Target enrollment

70 participants

Primary outcome timeframe

Approximately four hours post-induction of general anesthesia (or last recorded temperature)

Results posted on

2018-05-07

Participant Flow

Participant milestones

Participant milestones
Measure	Heated Ventilator Circuit Heated and humidified inspired gases using the ANAPOD™ Heat and Humidification System (Westmed; Tucson, Arizona, USA) circuit prior to induction of general anesthesia in addition to standard ventilation and temperature management. Heated Ventilator Circuit: active heat and humidification during anesthesia by warming inspire gases without a heat-moisture exchanger	Standard Ventilator Circuit Standard ventilation and temperature management Standard Ventilator Circuit: no active heat and humidification during anesthesia
Overall Study STARTED	35	35
Overall Study COMPLETED	35	35
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Heated Ventilator Circuit n=35 Participants Heated and humidified inspired gases using the ANAPOD™ Heat and Humidification System (Westmed; Tucson, Arizona, USA) circuit prior to induction of general anesthesia in addition to standard ventilation and temperature management. Heated Ventilator Circuit: active heat and humidification during anesthesia by warming inspire gases without a heat-moisture exchanger	Standard Ventilator Circuit n=34 Participants Standard ventilation and temperature management Standard Ventilator Circuit: no active heat and humidification during anesthesia	Total n=69 Participants Total of all reporting groups
Age, Continuous	63 years STANDARD_DEVIATION 11 • n=5 Participants • One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.	61 years STANDARD_DEVIATION 12 • n=7 Participants • One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.	62 years STANDARD_DEVIATION 11 • n=5 Participants • One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.
Sex: Female, Male Female	18 Participants n=5 Participants • One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.	16 Participants n=7 Participants • One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.	34 Participants n=5 Participants • One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.
Sex: Female, Male Male	17 Participants n=5 Participants • One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.	18 Participants n=7 Participants • One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.	35 Participants n=5 Participants • One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants • One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.	0 Participants n=7 Participants • One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.	0 Participants n=5 Participants • One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.
Race (NIH/OMB) Asian	0 Participants n=5 Participants • One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.	0 Participants n=7 Participants • One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.	0 Participants n=5 Participants • One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants • One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.	0 Participants n=7 Participants • One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.	0 Participants n=5 Participants • One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants • One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.	0 Participants n=7 Participants • One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.	0 Participants n=5 Participants • One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.
Race (NIH/OMB) White	34 Participants n=5 Participants • One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.	32 Participants n=7 Participants • One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.	66 Participants n=5 Participants • One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.
Race (NIH/OMB) More than one race	0 Participants n=5 Participants • One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.	0 Participants n=7 Participants • One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.	0 Participants n=5 Participants • One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants • One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.	2 Participants n=7 Participants • One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.	3 Participants n=5 Participants • One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.
Region of Enrollment United States	35 Participants n=5 Participants • One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.	34 Participants n=7 Participants • One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.	69 Participants n=5 Participants • One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.
BMI	28.21 kg/m^2 STANDARD_DEVIATION 4.61 • n=5 Participants • One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.	29.17 kg/m^2 STANDARD_DEVIATION 5.90 • n=7 Participants • One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.	28.69 kg/m^2 STANDARD_DEVIATION 5.25 • n=5 Participants • One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.
American Society of Anesthesiologists (ASA) Status ASA I or II	22 Participants n=5 Participants • One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.	21 Participants n=7 Participants • One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.	43 Participants n=5 Participants • One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.
American Society of Anesthesiologists (ASA) Status ASA III	13 Participants n=5 Participants • One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.	13 Participants n=7 Participants • One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.	26 Participants n=5 Participants • One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.

PRIMARY outcome

Timeframe: Approximately four hours post-induction of general anesthesia (or last recorded temperature)

Population: One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.

Core body temperature will be taken in the esophagus. The last recorded esophageal temperature will be used for surgeries not reaching 3 hours duration.

Outcome measures

Outcome measures
Measure	Heated Ventilator Circuit n=35 Participants Heated and humidified inspired gases using the ANAPOD™ Heat and Humidification System (Westmed; Tucson, Arizona, USA) circuit prior to induction of general anesthesia in addition to standard ventilation and temperature management. Heated Ventilator Circuit: active heat and humidification during anesthesia by warming inspire gases without a heat-moisture exchanger	Standard Ventilator Circuit n=34 Participants Standard ventilation and temperature management Standard Ventilator Circuit: no active heat and humidification during anesthesia
Core Body Temperature	36.8 degrees Celsius Standard Deviation 0.2	36.8 degrees Celsius Standard Deviation 0.2

SECONDARY outcome

Timeframe: Approximately 30 minutes, 60 minutes, 120 minutes post-induction of general anesthesia

Population: One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record. Data was obtained from 33 subjects in the treatment group at 60 minutes post-induction.

Core body temperature will be taken in the esophagus after general anesthesia induction.

Outcome measures

Outcome measures
Measure	Heated Ventilator Circuit n=35 Participants Heated and humidified inspired gases using the ANAPOD™ Heat and Humidification System (Westmed; Tucson, Arizona, USA) circuit prior to induction of general anesthesia in addition to standard ventilation and temperature management. Heated Ventilator Circuit: active heat and humidification during anesthesia by warming inspire gases without a heat-moisture exchanger	Standard Ventilator Circuit n=34 Participants Standard ventilation and temperature management Standard Ventilator Circuit: no active heat and humidification during anesthesia
Intraoperative Core Temperatures Post-induction ~30 minutes	36.1 degrees Celsius Standard Deviation 0.5	36.1 degrees Celsius Standard Deviation 0.4
Intraoperative Core Temperatures Post-induction ~60 minutes	35.8 degrees Celsius Standard Deviation 0.6	35.8 degrees Celsius Standard Deviation 0.5
Intraoperative Core Temperatures Post-induction ~120 minutes	36.1 degrees Celsius Standard Deviation 0.5	36.1 degrees Celsius Standard Deviation 0.4

SECONDARY outcome

Timeframe: Approximately 2 hours after completion of the surgery

Population: One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.

Shivering in the post-anesthesia care unit will be assessed using the Bedside Shivering Assessment Scale. This is a 4 point scale and rate shivering as the following: absent, mild, moderate, or severe. Only the highest degree of patient shivering was used in the analysis.

Outcome measures

Outcome measures
Measure	Heated Ventilator Circuit n=35 Participants Heated and humidified inspired gases using the ANAPOD™ Heat and Humidification System (Westmed; Tucson, Arizona, USA) circuit prior to induction of general anesthesia in addition to standard ventilation and temperature management. Heated Ventilator Circuit: active heat and humidification during anesthesia by warming inspire gases without a heat-moisture exchanger	Standard Ventilator Circuit n=34 Participants Standard ventilation and temperature management Standard Ventilator Circuit: no active heat and humidification during anesthesia
Number of Subjects With Post-operative Shivering Post-operative shivering	8 Participants	5 Participants
Number of Subjects With Post-operative Shivering No post-operative shivering or not assessed	27 Participants	29 Participants

SECONDARY outcome

Timeframe: Surgery to hospital discharge

Population: One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.

Number of days in the hospital

Outcome measures

Outcome measures
Measure	Heated Ventilator Circuit n=35 Participants Heated and humidified inspired gases using the ANAPOD™ Heat and Humidification System (Westmed; Tucson, Arizona, USA) circuit prior to induction of general anesthesia in addition to standard ventilation and temperature management. Heated Ventilator Circuit: active heat and humidification during anesthesia by warming inspire gases without a heat-moisture exchanger	Standard Ventilator Circuit n=34 Participants Standard ventilation and temperature management Standard Ventilator Circuit: no active heat and humidification during anesthesia
Hospital Length of Stay	3 number of days Interval 2.0 to 5.0	3 number of days Interval 2.0 to 5.0

SECONDARY outcome

Timeframe: PACU arrival

Temperature at Post Anesthesia Care Unit (PACU) arrival.

Outcome measures

Outcome measures
Measure	Heated Ventilator Circuit n=32 Participants Heated and humidified inspired gases using the ANAPOD™ Heat and Humidification System (Westmed; Tucson, Arizona, USA) circuit prior to induction of general anesthesia in addition to standard ventilation and temperature management. Heated Ventilator Circuit: active heat and humidification during anesthesia by warming inspire gases without a heat-moisture exchanger	Standard Ventilator Circuit n=34 Participants Standard ventilation and temperature management Standard Ventilator Circuit: no active heat and humidification during anesthesia
Overall Post-operative Temperature	36.6 degrees Celsius Standard Deviation 0.4	36.6 degrees Celsius Standard Deviation 0.4

SECONDARY outcome

Timeframe: Within 48 hours of surgery

Population: One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.

Requirement of blood transfusion within 48 hours of surgery

Outcome measures

Outcome measures
Measure	Heated Ventilator Circuit n=35 Participants Heated and humidified inspired gases using the ANAPOD™ Heat and Humidification System (Westmed; Tucson, Arizona, USA) circuit prior to induction of general anesthesia in addition to standard ventilation and temperature management. Heated Ventilator Circuit: active heat and humidification during anesthesia by warming inspire gases without a heat-moisture exchanger	Standard Ventilator Circuit n=34 Participants Standard ventilation and temperature management Standard Ventilator Circuit: no active heat and humidification during anesthesia
Number of Participants With Transfusion Within 48 Hours of Surgery No transfusion	21 Participants	23 Participants
Number of Participants With Transfusion Within 48 Hours of Surgery Transfusion	14 Participants	11 Participants

SECONDARY outcome

Timeframe: duration of surgery

Population: One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.

The estimated blood loss per case was determined by the anesthesia provider by measuring the volume of blood in the suction canister while taking into account the amount of irrigation solution used.

Outcome measures

Outcome measures
Measure	Heated Ventilator Circuit n=35 Participants Heated and humidified inspired gases using the ANAPOD™ Heat and Humidification System (Westmed; Tucson, Arizona, USA) circuit prior to induction of general anesthesia in addition to standard ventilation and temperature management. Heated Ventilator Circuit: active heat and humidification during anesthesia by warming inspire gases without a heat-moisture exchanger	Standard Ventilator Circuit n=34 Participants Standard ventilation and temperature management Standard Ventilator Circuit: no active heat and humidification during anesthesia
Estimated Blood Loss	450 milliters Interval 250.0 to 1000.0	425 milliters Interval 237.5 to 771.75

Adverse Events

Heated Ventilator Circuit

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Standard Ventilator Circuit

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Heated Ventilator Circuit n=35 participants at risk Heated and humidified inspired gases using the ANAPOD™ Heat and Humidification System (Westmed; Tucson, Arizona, USA) circuit prior to induction of general anesthesia in addition to standard ventilation and temperature management. Heated Ventilator Circuit: active heat and humidification during anesthesia by warming inspire gases without a heat-moisture exchanger	Standard Ventilator Circuit n=34 participants at risk Standard ventilation and temperature management Standard Ventilator Circuit: no active heat and humidification during anesthesia
Infections and infestations Infection	11.4% 4/35 • Number of events 4 • 30 days. One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.	8.8% 3/34 • Number of events 3 • 30 days. One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.
Blood and lymphatic system disorders Blood clot	2.9% 1/35 • Number of events 1 • 30 days. One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.	0.00% 0/34 • 30 days. One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.

Additional Information

Jean M. Guyer, DNP

Mayo Clinic

Phone: 507-255-5716

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place