Pilot Study for Verifying Endotracheal Tube Repositioning Using Ultrasound
A Pilot Study to Explore Alternative Methods for Verifying Endotracheal Tube Repositioning in the Surgical Intensive Care Unit
研究概览
详细说明
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.
For this study, additional data will be recorded: name, hospital record number, age, height, weight, gender, race, prior medical history, reason for SICU admission, reason for intubation, complications due to mechanical ventilation, days on mechanical ventilation (number of days prior to repositioning procedure and total number of days), length of stay, vital signs pre- and post-repositioning, including oxygen saturation, FiO2, and any peri-procedural vital sign abnormalities.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Connecticut
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New Haven、Connecticut、美国、06520
- Yale New Haven Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Intubated patients in the SICU requiring ETT repositioning will be identified by SICU clinicians.
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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Correlation between tube position measured by chest x-ray and the Air-Wave Device
大体时间:1 hour
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1 hour
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合作者和调查者
调查人员
- 学习椅:Kimberly A Davis, MD, MBA、Yale School of Medicine
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 1502015336
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
SonarMed Airwave Device的临床试验
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St. Louis UniversityLucerno Dynamics Limited Liability Company (LLC)完全的
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Taipei Veterans General Hospital, TaiwanLotung Poh-Ai Hospital未知
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University Hospital, Basel, SwitzerlandClinical Trial Unit, University Hospital Basel, Switzerland完全的