A Pilot Study to Explore Alternative Methods for Verifying Endotracheal Tube Repositioning in the Surgical Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Correlation between tube position measured by chest x-ray and the Air-Wave Device
研究概览
简要总结
The investigators will compare the response to oral endotracheal tube repositioning as measured by chest x-ray and measured by the air-wave device.
详细描述
Patients This prospective, non-randomized observational study will be conducted in the Surgical Intensive Care Unit (SICU) at Yale-New Haven Hospital. As this is a pilot study to determine the accuracy and precision of the SonarMed® AirWave™ monitor, the investigators have based our projected enrollment population to complete the study within one year. Intubated patients in the SICU requiring ETT repositioning will be identified by SICU clinicians (attending physicians, residents, respiratory therapists, and registered nurses). Based on manufacturer restrictions, patients with ETTs smaller than 6.5mm and larger than 9mm, double lumen ETTs, and those patients receiving Heliox therapy will be excluded from this study.
Study Procedures Once the patient is identified by a member of the clinical care team, this will be communicated to the research team.
A member of the research team will verify eligibility for the study, and then place the sensor and monitoring device into the airway circuit. The monitor is placed at the end of the endotracheal tube, in-line with the ventilator circuit.
Once the required distance for ETT repositioning is prescribed, the respiratory therapist will move the ETT based on the positioning at the incisors. This is standard practice. The device readings will be recorded pre- and post-repositioning. The therapist will be blinded to the device readings. The readings taken from the AirWave monitor are for research purposes only, and will not be considered when making clinical care decisions. Following repositioning, it is standard practice to obtain a follow up chest X-ray for confirmation of tube position within a two hour window. The same head positioning, noted on the original X-ray, will be maintained for the follow up X-ray. Device readings will also be taken at the time of the follow up X-ray. If the tube is to be further repositioned based on the decisions of the SICU team the device will be left in place until such time as the tube position has been fully optimized by the SICU team.
The ETT movement recorded by the AirWave™ monitoring device will be compared with the position change indicated on the chest X-ray. Once this has been completed, the monitor will be discontinued and removed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Intubated patients in the SICU requiring ETT repositioning will be identified by SICU clinicians.
排除标准
- •Based on manufacturer restrictions, patients with ETTs smaller than 6.5mm and larger than 9mm, double lumen ETTs, and those patients receiving Heliox therapy will be excluded from this study.
结局指标
主要结局
Correlation between tube position measured by chest x-ray and the Air-Wave Device
时间窗: 1 hour
次要结局
未报告次要终点
