Evaluating Adult Patient Temperatures During Lower Spinal Surgery
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-001604
NCT ID: NCT03050775
Sponsor Protocol Number: 15-001604
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential 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° on the day of surgery
- Active infection or erythema to the back
- White blood cell count greater than 10,500/microliter (mcL)
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Jean Guyer, APRN, CRNA, D.N.P. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available