Clinical trial NCT03050775: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hypothermia
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Westmed, Inc.
First posted: 2017-02-13
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, trial (treatment or no treatment)
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: Core Body Temperature
timeFrame: Approximately four hours post-induction of general anesthesia (or last recorded temperature)
Secondary outcomes:
measure: Intraoperative Core Temperatures Post-induction
timeFrame: Approximately 30 minutes, 60 minutes, 120 minutes post-induction of general anesthesia
measure: Number of Subjects With Post-operative Shivering
timeFrame: Approximately 2 hours after completion of the surgery
measure: Hospital Length of Stay
timeFrame: Surgery to hospital discharge
measure: Overall Post-operative Temperature
timeFrame: PACU arrival
measure: Number of Participants With Transfusion Within 48 Hours of Surgery
timeFrame: Within 48 hours of surgery
measure: Estimated Blood Loss
timeFrame: duration of surgery
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Jean M Guyer, DNP
role: PRINCIPAL_INVESTIGATOR
References: