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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.
Full description
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.
Hypothesis: Since it is a descriptive study, there is no formal hypothesis in this work.
Objectives
Objectives:
3.1. Main objective: To analyze the preferred device for intubation in patients infected by SARS-CoV2 virus during COVID-19 pandemics using a survey addressed to health care professionals experienced in assistance to COVID-19 patients. The preferred device will be rated using an ordinal scoring scale and it will be presented as the device with the highest score.
3.2. Secondary objectives: To assess the preferred methods for airway management in COVID-19 patients in a Critical Care setting or undergoing urgent or elective surgery.
Design: Descriptive design with no hypothesis contrast, exploring the current panorama in airway management in Spain and Latin America.
Ambit: Multicenter and international for Spain and Latin America, for all the health care centers where intubations or tracheostomies have been performed in COVID-19 patients with a positive PCR, either in the Critical Care setting or in the operating room.
Study population: The study population will consist of all the health care professionals who have been or are currently involved in airway management in COVID-19 positive patients, from the following medical specialties: Anesthesiology and Critical Care Medicine, Emergency Medicine, Pre-Hospital Medicine, Cardiology, Pulmonology.
Variables:
7.1. Main variable: Optimal device: Which is the best rated device for endotracheal intubation in COVID-19 patients.
7.2. Secondary variables:
Specific variables in the thoracic surgery context, to be answered only by professionals working with such patients:
Information sources: Variables will be obtained from a voluntary survey accessible from the Internet, created with Microsoft Forms ®. Microsoft Forms ® is a digital platform with a free access plan which allows quick and development of digital surveys with no need for programming. It also includes a set of tools to distribute and gather the results from the questionnaires. The survey is accessed from a link sent via e-mail or other digital distribution methods to the potential participants.
Interventions and procedures: There is no need for interventions on patients or their clinical records. A single intervention will take place on the participants in the moment of sending the survey. This only contact will provide all the aforementioned variables.
Sample size calculation: There is no need for sample size calculation, since the study is explorative and voluntary, trying to assess clinical routines in airway management.
Statistical plan: 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. Proper figures will be presented to represent the results about which are the most used techniques and devices, as well as the most important features of every procedure.
Ethical considerations:
12.1. General considerations: The study is to be conducted according to this protocol, Helsinki Ethical Principles Declaration and currently existing directives.
12.2. Informed consent: An informed consent form is not necessary, since the survey will be completed by professionals who provided care to the patients in a retrospective manner, with no diagnostic or therapeutic interventions. Besides, since it is a retrospective study with anonymous data, there is no possibility to ask for an informed consent to the patients. For these reasons, an exemption for informed consent was requested and accepted by the Ethics Committee.
12.3. Data protection: Data from the participants will be managed according to existing spanish and european laws (Spanish Law 3/2018 on Personal Data Protection and Digital Rights Warranty, and EU Regulation UE 2016/679). Gathered data for the study will be identified with a code, and the information will not include identificatory details of the participants, thus not being able to reveal their identities. Names of patients will not be collected or presented in any publication or communication of the study results.
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Inclusion and exclusion criteria
Inclusion Criteria: Professionals belonging to medical specialties involved in airway management who have performed intubation and/or tracheostomy maneuvers in COVID-19 patients during current pandemics.
Exclusion Criteria:
5,000 participants in 1 patient group
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Central trial contact
Manuel Granell Gil; Manuel Granell Gil, PhD
Data sourced from clinicaltrials.gov
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