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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 70
- 主要终点
- Core Body Temperature
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: Heated Ventilator Circuit (Device)
Standard Ventilator Circuit
Standard ventilation and temperature management.
干预措施: Standard Ventilator Circuit (Device)
结局指标
主要结局
Core Body Temperature
时间窗: Approximately four hours post-induction of general anesthesia (or last recorded 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.
次要结局
- Estimated Blood Loss(duration of surgery)
- 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)
研究者
Jean M. Guyer
Principal Investigator
Mayo Clinic