Time to Adapt in the Pandemic Era: A Prospective Randomized Study Comparing Time to Intubate With and Without the Barrier Box
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Time to Intubate
研究概览
简要总结
This study is for patients who will be having surgery and will have a breathing tube placed during intubation. The purpose of the research is to study the time it takes to use a barrier box for placement of a breathing tube. A barrier box is a clear box that sits over the head and shoulders of a patient as a breathing tube is placed. The box is used to protect the healthcare provider's exposure to coronavirus in patients who have COVID-19. The study will not include patients who test positive for COVID-19 or who are sick with COVID-19 symptoms. The researchers want to learn how long it takes to use the barrier box before it is used routinely in COVID-19 patients.
详细描述
The study will have two groups of 39 patients in each group. Some patients will have a barrier box and some patients will not have a barrier box. Patients will be randomly assigned to the barrier box or no barrier box group. The study will measure the time it takes to place the breathing tube.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients presenting for surgery needing general anesthesia with endotracheal intubation
- •pre-operatively tested negative for SARS- CoV-2 virus
排除标准
- •inability to consent or cooperate,
- •pregnant women
- •patients with severe cardiopulmonary compromise
- •American Society Anesthesiologists' (ASA) physical status 4 and 5
- •Body Mass Index (BMI) >35
- •known or anticipated difficult airway
- •patients with positive COVID status or unknown COVID status
- •patients who reported claustrophobia in the pre-operative area
研究组 & 干预措施
Barrier box
Participants will have a barrier box placed during intubation for a medical procedure. A barrier box is a medical device which was in use from May 1, 2020 to August 20, 2020 during the COVID-19 pandemic. The device is a barrier enclosure to protect healthcare providers caring for or performing medical procedures (such as intubation) on patients who are known or suspected to have COVID-19.
干预措施: Barrier box (Other)
No Barrier box
Participants will have routine intubation with no barrier box
结局指标
主要结局
Time to Intubate
时间窗: up to 2 minutes during intubation before surgery
Time to intubate refers to the time it takes to insert a tube into a patient's trachea to help them breathe. Intubation is a procedure routinely used before surgery to help keep the airway open. The study will compare the time to intubate in two groups, barrier box and no barrier box. In medical terms, time to intubate is the time from loss of twitches confirmed with a peripheral nerve stimulator to confirmation of end tidal carbon dioxide.
次要结局
- Intubation in First Attempt(up to 2 minutes during intubation before surgery)
- Need for Bag Mask Ventilation(up to 5 minutes)
- Participants' Lowest Blood Oxygen Level (Lowest Oxygen Saturation During Induction and Intubation)(up to 5 minutes)
- Induction Time(up to 5 minutes)