Large Scale Cerebral Oximetry During Sinus Endoscopy
关键词
抽象
描述
Research Plan
This study will be conducted at Mount Sinai Hospital. Patients will be recruited by reading the operating room schedule in advance and contacting patients over the phone to explain the study, risks and benefits, and obtain informed consent prior to admission to the hospital.
Objective 1 The specific aim of this observational study is to evaluate changes in cerebral tissue oxygen saturation in patients undergoing head and neck surgery under general anesthesia with mechanical ventilation using the Casmed Foresight cerebral oximeter.
Ensuring patient safety in surgeries upon the head and neck is a complex task in anesthesiology. These patients present a myriad of concerns that need to be considered to create a safe and thorough anesthetic plan that include potentially difficult airways, varied patient positioning, and the intricate involvement of anesthetic drugs upon the quality of the surgical field. During common procedures such as sinus endoscopy, patients undergo endotracheal intubation and mechanical ventilation for airway protection and a strategy of deliberate hypotension is implemented with the goal of creating a clean surgical field that minimizes avoidable bleeding. The objective of this strategy is to allow the surgeons to complete their procedure more quickly and with less hypothetical risk of injury due to poor visualization of structures. However, this strategy of deliberate hypotension carries with it the potential risk of cerebral hypoperfusion as the lower limits of cerebral autoregulation are not known on an individual patient basis. Furthermore, mechanical ventilation- particularly with hyperventilation- can further decrease cerebral blood flow and potentially compromise cerebral perfusion. The current standard of care to monitor the hemodynamics of patients undergoing these procedures are standard American Society of Anesthesiologists monitors, which includes non-invasive blood pressure measurements. The investigators propose the use of a non-invasive monitor of cerebral oxygenation with cerebral oximeter probes in a prospective, observational study of a series of patients undergoing routine head and neck surgery.
日期
最后验证: | 07/31/2017 |
首次提交: | 02/22/2016 |
提交的预估入学人数: | 02/22/2016 |
首次发布: | 02/25/2016 |
上次提交的更新: | 08/07/2017 |
最近更新发布: | 08/09/2017 |
实际学习开始日期: | 09/30/2015 |
预计主要完成日期: | 06/19/2016 |
预计完成日期: | 06/19/2016 |
状况或疾病
相
资格标准
有资格学习的年龄 | 18 Years 至 18 Years |
有资格学习的性别 | All |
取样方式 | Non-Probability Sample |
接受健康志愿者 | 是 |
标准 | Inclusion Criteria: - patients undergoing elective head and neck surgery at Mount Sinai Hospital in which 1) the patient will be intubated and mechanically ventilated, with 2) head of bed elevated, and in which 3) an anesthesiologist could consider deliberate hypotension as part of their management Exclusion Criteria: - patients under 18 years old - patients who are currently prisoners - patients who do not appear to have capacity to consent to the study - patients who cannot provide informed consent in English - pregnant women - patients who decline to participate in the study. |
结果
主要结果指标
1. Post-operative Quality of Recovery Scale [Day 1- 1 hour post-operatively]
2. Post-operative Quality of Recovery Scale [Day 2]
次要成果指标
1. Incidence of nausea/vomiting [Day 1 - 1 hour post-operatively]
其他成果措施
1. Incidence of pain experience [Day 1 - 1 hour post-operatively]