NCT04487977

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 22, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 27, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

July 27, 2020

Status Verified

July 1, 2020

Enrollment Period

5 months

First QC Date

July 23, 2020

Last Update Submit

July 24, 2020

Conditions

Keywords

airwayCOVID-19critical careanesthesiaairway management

Outcome Measures

Primary Outcomes (1)

  • Preferred device

    Preferred device for intubation in COVID-19 patients infected by SARS-CoV2

    During COVID-19 pandemics in each country, since the release of the survey until its closure, approximately 4 months

Study Arms (1)

Surveyed professionals

Other: Survey

Interventions

SurveyOTHER

Answering a survey on airway management in COVID-19 patients

Surveyed professionals

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Professionals belonging to medical specialties involved in airway management who have performed intubation and/or tracheostomy maneuvers in COVID-19 patients during current pandemics.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Consorcio Hospital General Universitario de Valencia

Valencia, 46022, Spain

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Manuel Granell Gil, PhD

CONTACT

Manuel Granell Gil

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 23, 2020

First Posted

July 27, 2020

Study Start

April 22, 2020

Primary Completion

September 30, 2020

Study Completion

September 30, 2020

Last Updated

July 27, 2020

Record last verified: 2020-07

Locations