Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04487977 |
| Other study ID # |
ISAM-COVID |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 22, 2020 |
| Est. completion date |
September 30, 2020 |
Study information
| Verified date |
July 2020 |
| Source |
Spanish Society of Anesthesia and Critical Care (SEDAR) |
| Contact |
Manuel Granell Gil, PhD |
| Phone |
+34609232031 |
| Email |
mgranellg[@]hotmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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.
Description:
1. 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:
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.
4. Design: Descriptive design with no hypothesis contrast, exploring the current panorama
in airway management in Spain and Latin America.
5. 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.
6. 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.
7. Variables:
7.1. Main variable: Optimal device: Which is the best rated device for endotracheal
intubation in COVID-19 patients.
7.2. Secondary variables:
- Context in which the professional has experience when intubation COVID-19 patient:
1. Critical Context (Emergency Department, Critical Care Unit), 2. Emergent
Surgery, 3. Elective Surgery.
- Professional opinion about the usefulness of different systems for reducing aerosol
production or diffusion (from 1 to 6, where 1 is the least useful and 6 is the most
useful): 1. Methacrylate box with accesses for the arms, 2. Face mask tight seal,
3. Negative pressure system in the intubation area, 4. Avoidance of hand
ventilation, 5. Rapid sequence intubation, 6. Sellick maneuver, 7. Other.
- Professional opinion about the importance of the different drawbacks of video
laryngoscopes (from 1 to 6, where 1 is the most important and 6 is the least
important): 1. Reflections on the screen, 2. Difficulty to introduce the blade in
the mouth, 3. Proximity to the patient's airway, 4. Difficulty to insert the tube
through the vocal cords, 5. Lack of experience with the specific video laryngoscope
used, 6. Preference for direct laryngoscopy due to higher experience and confidence
with it.
- Type of blade most often used by use: 1. Reusable, 2. Disposable.
- Type of blade most often used by channel: 1. With channel, 2. Without channel.
- Type of blade most often used by curvature: 1. Regular curve, 2. Hyper Curved.
- Type of video laryngoscope screen: 1. Integrated with the main device, 2. Away from
the device.
- Type of aid device (from 1 to 6, where 1 is the least useful and 6 is the most
useful): 1. Frova introducer, 2. Eschman introducer, 3. Flexible introducer inside
the tube, 4. Flexible endoscope, 5. VAMA, 6. Other.
- Preferred method for intubation in the foreseen difficult airway situation (from 1
to 6, where 1 is the most preferred and 6 is the least preferred): 1. Fiberoptic
intubation, 2. Intubation with video laryngoscope, 3. Direct laryngoscopy, 4. McCoy
laryngoscope, 5. Intubation through a laryngeal mask, 6. Tracheostomy.
- Preferred method for intubation in the unforeseen difficult airway situation (from
1 to 6, where 1 is the least preferred and 6 is the most preferred):1. Fiberoptic
intubation, 2. Intubation with video laryngoscope, 3. Direct laryngoscopy, 4. McCoy
laryngoscope, 5. Intubation through a laryngeal mask, 6. Tracheostomy.
- Preferred strategies upon surgical conclusion in COVID-19 patients (from 1 to 6,
where 1 is the least preferred and 6 is the most preferred): 1. To extubate all
patients in the Critical Care Unit, 2. To extubate all patients in the operating
room, 3. To extubate only stable patients in the operating room, if postoperative
ventilation os not expected, 4. Other.
- Preferred procedures in intubated COVID-19 patients who need a tracheostomy (from 1
to 6, where 1 is the least preferred and 6 is the most preferred): 1. Open
conventional tracheostomy, 2. Percutaneous tracheostomy, 3. Fiberoptic guidance to
conduct location and opening of the trachea, 4. Apnea or ventilator stand-by for as
long as possible.
- Professional rating of different assertions about techniques and equipment to
intubate COVID-19 patients (from 1 to 6, where 1 is the lowest validity and 6 is
the highest validity): 1. It is concerning to use reusable material with the
possibility of contamination, 2. It is concerning to move intubation equipment from
COVID-19 to non-COVID-19 areas, 3. Swiftly intubating critical or severely
deteriorated COVID-19 patients is related to a higher risk of transmission, 4.
Airway management maneuvers with personal protective equipment are more difficult
and uncomfortable.
Specific variables in the thoracic surgery context, to be answered only by professionals
working with such patients:
- Experience in thoracic anesthesia: 1. Over 10 years, 2. From 5 to 10 years, 3.
Under 5 years, 4. No experience.
- Preferred method to perform lung isolation in COVID-19 patients (from 1 to 6, where
1 is the least preferred and 6 is the most preferred): 1. Conventional double lumen
tubes and flexible endoscope, 2. Double lumen tubes with attached camera, 3.
Bronchial blocker, endotracheal tube and flexible endoscope, 4. Bronchial blocker
and endotracheal tube with attached camera (Viva Sight ®), 5. Univent ® tube and
flexible endoscope, 6. Other.
- Preferred video laryngoscope for double lumen tube insertion in COVID-19 patients
with a difficult airway (from 1 to 6, where 1 is the least preferred and 6 is the
most preferred): 1. C-MAC ®, 2. King Vision ®, 3. McGrath ®, 3. GlideScope ®, 4.
Airtraq ®, 5. Other.
- Preferred bronchial blocker for COVID-19 patients (from 1 to 6, where 1 is the
least preferred and 6 is the most preferred): 1. Arndt, 2. Cohen, 3. Univent ®
tube, 4. EZ Blocker ®, 5. Fogarty catheter, 6. Other)
- Preferred position for the antiviral /antibacterial filter (from 1 to 6, where 1 is
the least preferred and 6 is the most preferred): 1. Expiratory branch, 2.
Inspiratory branch, 3. Y bifurcation, 4. Proximal end of the endobronchial lumen of
the double lumen tube, leading to the non ventilated lung to be collapsed, 5.
Proximal end of the bronchial blocker, if it is used.
- Usefulness of the closed and regulable aspiration system for the non ventilated
lung: 1. Yes, 2. No.
- Preferred strategies upon surgical conclusion in COVID-19 patients (from 1 to 6,
where 1 is the least preferred and 6 is the most preferred): 1. To extubate all
patients in the Critical Care Unit, 2. To extubate all patients in the operating
room, 3. To extubate only stable patients in the operating room, if postoperative
ventilation os not expected, 4. To exchange the double lumen tube for an
endotracheal tube and extubation in the post anesthesia unit, 5. To withdraw the
double lumen tube to the trachea for subsequent extubation in the post anesthesia
unit, 6. To remove the bronchial blocker and leave the endotracheal tube for
subsequent extubation in the post anesthesia unit, 7. To remove the bronchial
blocker from the Univent ® tube and subsequent extubation in the post anesthesia
unit, 8. Other.
- Number of intubations performed in COVID-19 patients.
- Personal SARS-CoV-2 infection: 1. Yes, 2. No.
8. 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.
9. 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.
10. 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.
11. 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.
12. 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.
