Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluating Adult Patient Temperatures During Lower Spinal Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03050775
Recruitment Status : Completed
First Posted : February 13, 2017
Results First Posted : May 7, 2018
Last Update Posted : May 7, 2018
Sponsor:
Collaborator:
Westmed, Inc.
Information provided by (Responsible Party):
Jean M. Guyer, Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Hypothermia Device: Heated Ventilator Circuit Device: Standard Ventilator Circuit Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized, trial (treatment or no treatment)
Masking: Double (Participant, Outcomes 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.
Primary Purpose: Prevention
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
Actual Study Start Date : August 28, 2015
Actual Primary Completion Date : February 5, 2017
Actual Study Completion Date : February 5, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia

Arm Intervention/treatment
Experimental: 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.
Device: Heated Ventilator Circuit
active heat and humidification during anesthesia by warming inspire gases without a heat-moisture exchanger
Other Name: ANAPOD™ Heat and Humidification System

Active Comparator: Standard Ventilator Circuit
Standard ventilation and temperature management.
Device: Standard Ventilator Circuit
no active heat and humidification during anesthesia
Other Name: Thermovent 600; Portex




Primary Outcome Measures :
  1. Core Body Temperature [ Time Frame: Approximately four hours post-induction of general anesthesia (or last recorded 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 :
  1. Intraoperative Core Temperatures Post-induction [ Time Frame: Approximately 30 minutes, 60 minutes, 120 minutes post-induction of general anesthesia ]
    Core body temperature will be taken in the esophagus after general anesthesia induction.

  2. Number of Subjects With Post-operative Shivering [ Time Frame: Approximately 2 hours after completion of the surgery ]
    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.

  3. Hospital Length of Stay [ Time Frame: Surgery to hospital discharge ]
    Number of days in the hospital

  4. Overall Post-operative Temperature [ Time Frame: PACU arrival ]
    Temperature at Post Anesthesia Care Unit (PACU) arrival.

  5. Number of Participants With Transfusion Within 48 Hours of Surgery [ Time Frame: Within 48 hours of surgery ]
    Requirement of blood transfusion within 48 hours of surgery

  6. Estimated Blood Loss [ Time Frame: duration of surgery ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03050775


Sponsors and Collaborators
Mayo Clinic
Westmed, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Jean M Guyer, DNP Mayo Clinic
  Study Documents (Full-Text)

Documents provided by Jean M. Guyer, Mayo Clinic:
Layout table for additonal information
Responsible Party: Jean M. Guyer, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03050775    
Other Study ID Numbers: 15-001604
UL1TR000135 ( U.S. NIH Grant/Contract )
First Posted: February 13, 2017    Key Record Dates
Results First Posted: May 7, 2018
Last Update Posted: May 7, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypothermia
Body Temperature Changes
Signs and Symptoms