Evaluating Adult Patient Temperatures During Lower Spinal Surgery
Primary Purpose
Hypothermia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Heated Ventilator Circuit
Standard Ventilator Circuit
Sponsored by
About this trial
This is an interventional prevention trial for Hypothermia
Eligibility Criteria
Inclusion Criteria:
- Elective spine surgery anticipated greater than three hours in duration
- Posterior approach
- An operative site between lumbar one and sacral one
- Involving two or more levels with fusion and/or instrumentation and/or revisions
- American Society of Anesthesiologists (ASA) Status of I-III
Exclusion Criteria:
- Patients with a tracheostomy
- Preoperative temperature >38°C or <36°C on the day of surgery
- Active infection or erythema to the back
- White blood cell count greater than 10,500/microliter (mcL)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Heated Ventilator Circuit
Standard Ventilator Circuit
Arm Description
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.
Standard ventilation and temperature management.
Outcomes
Primary Outcome Measures
Core Body Temperature
Core body temperature will be taken in the esophagus. The last recorded esophageal temperature will be used for surgeries not reaching 3 hours duration.
Secondary Outcome Measures
Intraoperative Core Temperatures Post-induction
Core body temperature will be taken in the esophagus after general anesthesia induction.
Number of Subjects With Post-operative Shivering
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.
Hospital Length of Stay
Number of days in the hospital
Overall Post-operative Temperature
Temperature at Post Anesthesia Care Unit (PACU) arrival.
Number of Participants With Transfusion Within 48 Hours of Surgery
Requirement of blood transfusion within 48 hours of surgery
Estimated Blood Loss
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.
Full Information
NCT ID
NCT03050775
First Posted
February 9, 2017
Last Updated
May 3, 2018
Sponsor
Mayo Clinic
Collaborators
Westmed, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03050775
Brief Title
Evaluating Adult Patient Temperatures During Lower Spinal Surgery
Official Title
Comparing Patient Temperatures in Adults During Lower Spinal Surgery Using Either a Heated Ventilator Circuit or a Standard Ventilator Circuit With a Heat-Moisture Exchanger
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
August 28, 2015 (Actual)
Primary Completion Date
February 5, 2017 (Actual)
Study Completion Date
February 5, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
Westmed, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate patients' temperatures after using one of two ventilator circuits (breathing systems): the ANAPOD™ Heat and Humidification System (ANAPOD™ system) or the standard ventilator circuit with a heat-moisture exchanger (standard ventilator). The ANAPOD™ system will provide additional heat and humidity to patients through their breathing tube while the standard ventilator will not. The investigators are doing this research study to find out if the ventilator circuit providing additional heat and humidity will keep patients warmer during surgery and after surgery.
Detailed Description
Patients were randomly assigned to either the treatment group or the control group prior to surgery. Prior to induction, patients in the control group were given inspiratory gas at ambient air temperature (20-22 degrees Celsius) and patients in the treatment group were given inspiratory gas at warmed temperatures (40-41 degrees Celsius). All patients were induced with general anesthesia in the supine position and repositioned prone following endotracheal intubation and placement of an esophageal stethoscope with a temperature sensor, as per usual hospital practice. Esophageal temperatures were recorded within 30 minutes of the baseline esophageal temperature and every 10 minutes thereafter for the first hour post-induction. All patients had a blanket and forced air warming applied to their lower extremities and upper back at 43 degrees Celsius after draping. All patients had esophageal temperature measurements recorded every 30 minutes until the patient was repositioned supine. Core temperatures were recorded four hours post-induction for those patients reaching that timeframe.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized, trial (treatment or no treatment)
Masking
ParticipantOutcomes Assessor
Masking Description
Patients were randomly assigned to either the treatment group or the control group prior to surgery. Group randomization was performed using a randomization schedule prepared by the Division of Clinical Statistics with patients randomized in blocks of four. For consented and enrolled patients on the day of surgery in the admit areas, a participant was assigned the next sequential participant ID number and the appropriate sealed envelope was opened to reveal the participant's randomized intervention. This occurred before the patient was transferred to the operating suite. Individuals who performed data analysis were blinded to treatment group.
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Heated Ventilator Circuit
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Ventilator Circuit
Arm Type
Active Comparator
Arm Description
Standard ventilation and temperature management.
Intervention Type
Device
Intervention Name(s)
Heated Ventilator Circuit
Other Intervention Name(s)
ANAPOD™ Heat and Humidification System
Intervention Description
active heat and humidification during anesthesia by warming inspire gases without a heat-moisture exchanger
Intervention Type
Device
Intervention Name(s)
Standard Ventilator Circuit
Other Intervention Name(s)
Thermovent 600; Portex
Intervention Description
no active heat and humidification during anesthesia
Primary Outcome Measure Information:
Title
Core Body Temperature
Description
Core body temperature will be taken in the esophagus. The last recorded esophageal temperature will be used for surgeries not reaching 3 hours duration.
Time Frame
Approximately four hours post-induction of general anesthesia (or last recorded temperature)
Secondary Outcome Measure Information:
Title
Intraoperative Core Temperatures Post-induction
Description
Core body temperature will be taken in the esophagus after general anesthesia induction.
Time Frame
Approximately 30 minutes, 60 minutes, 120 minutes post-induction of general anesthesia
Title
Number of Subjects With Post-operative Shivering
Description
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.
Time Frame
Approximately 2 hours after completion of the surgery
Title
Hospital Length of Stay
Description
Number of days in the hospital
Time Frame
Surgery to hospital discharge
Title
Overall Post-operative Temperature
Description
Temperature at Post Anesthesia Care Unit (PACU) arrival.
Time Frame
PACU arrival
Title
Number of Participants With Transfusion Within 48 Hours of Surgery
Description
Requirement of blood transfusion within 48 hours of surgery
Time Frame
Within 48 hours of surgery
Title
Estimated Blood Loss
Description
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.
Time Frame
duration of surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Elective spine surgery anticipated greater than three hours in duration
Posterior approach
An operative site between lumbar one and sacral one
Involving two or more levels with fusion and/or instrumentation and/or revisions
American Society of Anesthesiologists (ASA) Status of I-III
Exclusion Criteria:
Patients with a tracheostomy
Preoperative temperature >38°C or <36°C on the day of surgery
Active infection or erythema to the back
White blood cell count greater than 10,500/microliter (mcL)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean M Guyer, DNP
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Evaluating Adult Patient Temperatures During Lower Spinal Surgery
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