International Survey on Airway Management in COVID-19 Patients (ISAM-COVID)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Preferred device
研究概览
简要总结
The objectives of this study are to analyze the best device for intubation in patients infected by SARS-CoV2 virus during COVID-19 pandemics and to review the optimal methods for airway management in such patients for elective surgery and in the Critical Care environment. Also, the safest methods for airway management in thoracic surgery will be analyzed.
This study has a descriptive design with no hypothesis contrast, and it will explore the current picture in airway management in Spain. It is a multicentric international study, for all the centers where intubations of tracheostomies have been performed in patients diagnosed with SARS-CoV2 with positive PCR, either in the Critical Care setting or the operating room.
A survey will be distributed among professionals who have been involved in airway management in COVID-19 patients in the following specialties: Anesthesiology and Critical Care Medicine, Emergency Medicine, Prehospital Medicine, Cardiology and Pulmonology.
The study started on april 2020 after receiving approval from the Ethics Committee (General University Hospital of Valencia) COVID-19 infection causes respiratory failure needing ventilatory support, which required endotracheal intubation or tracheostomy. This situation poses a significant risk of transmission due to its usual urgent nature, and it often happens in the context of respiratory claudication. For this reason, studying the safest and useful methods for airway management in this kind of patients, using data based on the clinical experience, may be of great interest in the future.
Statistical analysis will be performed using Statistical Software R, . Technical characteristics will be described using frequencies and percentages for categorical variables, and means and standard deviations or medians and interquartile ranges for continuous variables, depending on normality tests. Base characteristics, center and years of experience will be compared.
A sample size calculation is not necessary, since it is an explorative and voluntary study, trying to establish which are the regular routines in airway management in COVID-19 patients in Spain and Latin America.
详细描述
- Justification There are no studies about safety and effectiveness of different airway management procedures in COVID-19 patients in Spain or Latin America.
Due to the emergent nature of this disease, there are very few solid and universal publications about safety or validated protocols in SARS-CoV-2 disease airway management.
In the last months, and following the clinical experience coming from China and Italy, we have been able to see how SARS-CoV-2 virus has caused severe morbidity or death in thousands of patients. In this line, and considering the high transmission rate of this disease, we observe how professionals from these countries have performed airway management to provide proper ventilation and oxygenation, in either potentially critically ill patients or in a surgical context. Their experience has allowed other countries to develop specific protocols, and to quickly adapt them to the updates that keep happening daily.
For this reason, we want to explore the Spanish and Latin American experience in airway management. It is important to draw conclusions not only from the preparations and technical approaches, but also the information stemming from the context in which the procedure is performed, the stress derived from the risk of transmission and the personal protective equipment, as well as the particular difficulties they add to the technique. 2. Hypothesis: Since it is a descriptive study, there is no formal hypothesis in this work.
Objectives 3. Objectives:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Professionals belonging to medical specialties involved in airway management who have performed intubation and/or tracheostomy maneuvers in COVID-19 patients during current pandemics.
排除标准
- •Professionals not belonging to medical specialties involved in airway management or with no experience in intubation/tracheostomy maneuvers.
- •Those not willing to answer the survey.
结局指标
主要结局
Preferred device
时间窗: During COVID-19 pandemics in each country, since the release of the survey until its closure, approximately 4 months
Preferred device for intubation in COVID-19 patients infected by SARS-CoV2
次要结局
未报告次要终点
研究者
Dr. Manuel Granell Gil
Professor
Spanish Society of Anesthesia and Critical Care (SEDAR)