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NCT Number: NCT03050775

Evaluating Adult Patient Temperatures During Lower Spinal Surgery

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.

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Key information

Conditions

Hypothermia Body Temperature Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Heated Ventilator Circuit

Device

active heat and humidification during anesthesia by warming inspire gases without a heat-moisture exchanger

Other names: ANAPOD™ Heat and Humidification System

Standard Ventilator Circuit

Device

no active heat and humidification during anesthesia

Other names: Thermovent 600; Portex

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Westmed, Inc.

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 13, 2017
Registry last updated
May 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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