Evaluating Adult Patient Temperatures During Lower Spinal Surgery

NCT03050775 | Completed Results FDA Device

• 2 other identifiers: 15-001604UL1TR000135
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypothermia

Outcome Measures

Primary Outcomes (1)

• 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.

  Approximately four hours post-induction of general anesthesia (or last recorded temperature)

Secondary Outcomes (6)

• Intraoperative Core Temperatures Post-induction

  Approximately 30 minutes, 60 minutes, 120 minutes post-induction of general anesthesia

• Number of Subjects With Post-operative Shivering

  Approximately 2 hours after completion of the surgery

• Hospital Length of Stay

  Surgery to hospital discharge

• Overall Post-operative Temperature

  PACU arrival

• Number of Participants With Transfusion Within 48 Hours of Surgery

  Within 48 hours of surgery

Study Arms (2)

Heated Ventilator Circuit

EXPERIMENTAL

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

Standard Ventilator Circuit

ACTIVE COMPARATOR

Standard ventilation and temperature management.

Device: Standard Ventilator Circuit

Interventions

Heated Ventilator Circuit DEVICE

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

Also known as: ANAPOD™ Heat and Humidification System

Heated Ventilator Circuit

Standard Ventilator Circuit DEVICE

no active heat and humidification during anesthesia

Also known as: Thermovent 600; Portex

Standard Ventilator Circuit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mayo Clinic: lead
• Westmed, Inc.: collaborator

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

The study was not blinded; investigators were unable to verify exact placement of the esophageal temperature probe; post-op shivering assessments and both OR and ANAPOD temperatures were not consistently recorded at regular intervals.

Results Point of Contact

• Title: Jean M. Guyer, DNP
• Organization: Mayo Clinic

guyer.jean@mayo.edu

507-255-5716

Study Officials

• Jean M Guyer, DNP

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: randomized, trial (treatment or no treatment)

Study Record Dates

• First Submitted: February 9, 2017
• First Posted: February 13, 2017
• Study Start: August 28, 2015
• Primary Completion: February 5, 2017
• Study Completion: February 5, 2017
• Last Updated: May 7, 2018
• Results First Posted: May 7, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share