N/A
N=70
Evaluating Adult Patient Temperatures During Lower Spinal Surgery
Hypothermia
Bottom Line
View on ClinicalTrials.gov: NCT03050775 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
May 2018
Primary outcome: Primary: Core Body Temperature — 36.8; 36.8 degrees Celsius — p=0.807
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Heated Ventilator Circuit (Device); Standard Ventilator Circuit (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Core Body Temperature |
36.8; 36.8 | 0.807 |
| SECONDARY Intraoperative Core Temperatures Post-induction |
36.1; 36.1; 35.8; 35.8; 36.1; 36.1 | 0.823 |
| SECONDARY Number of Subjects With Post-operative Shivering |
8; 5; 27; 29 | 0.540 |
| SECONDARY Hospital Length of Stay |
3; 3 | 0.672 |
| SECONDARY Overall Post-operative Temperature |
36.6; 36.6 | 0.571 |
| SECONDARY Number of Participants With Transfusion Within 48 Hours of Surgery |
21; 23; 14; 11 | 0.619 |
| SECONDARY Estimated Blood Loss |
450; 425 | 0.404 |
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.
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)
Data sourced from ClinicalTrials.gov (NCT03050775). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.