Evaluating Adult Patient Temperatures During Lower Spinal Surgery

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-28

Study Completion Date

2017-02-05

Brief Summary

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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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Detailed Description

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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.

Conditions

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Hypothermia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized, trial (treatment or no treatment)

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

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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.

Group Type EXPERIMENTAL

Heated Ventilator Circuit

Intervention Type DEVICE

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

Standard Ventilator Circuit

Standard ventilation and temperature management.

Group Type ACTIVE_COMPARATOR

Standard Ventilator Circuit

Intervention Type DEVICE

no active heat and humidification during anesthesia

Interventions

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Heated Ventilator Circuit

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

Intervention Type DEVICE

Standard Ventilator Circuit

no active heat and humidification during anesthesia

Intervention Type DEVICE

Other Intervention Names

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ANAPOD™ Heat and Humidification System Thermovent 600; Portex

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes