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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
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypothermia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    February 9, 2017
    Last Updated
    May 3, 2018
    Sponsor
    Mayo Clinic
    Collaborators
    Westmed, Inc.
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    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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