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Clinical Trials/NCT04909476
NCT04909476
Unknown
Not Applicable

Airways Management in COVID-19 Related Respiratory Failure: a Prospective Observational Multi-center Study

St. Bortolo Hospital2 sites in 1 country143 target enrollmentNovember 17, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COVID-19 Pneumonia
Sponsor
St. Bortolo Hospital
Enrollment
143
Locations
2
Primary Endpoint
Major adverse peri-intubation events
Last Updated
4 years ago

Overview

Brief Summary

The Emergency Endotracheal intubation of a patient who is COVID-19 positive is a high-risk procedure and an additional challenge to an intensivist due to barrier enclosures that have been developed to reduce the risk of COVID-19 transmission to healthcare providers during intubation. Although the incidence of difficult airways is commonly higher in critically ill patients, the evidence of severe hypoxemia without sign of respiratory distress could complicate the scenario.This silent hypoxia often leads to a delayed recognition of the severity of respiratory failure and to a late intubation which is often characterized by a high risk of complications related to the actual airways' management, hemodynamic and cardiac. It has been shown that non-survivors had worse blood gas analyzes than survivors, both before and after intubation. Few studies have reported the implications and adverse events of performing endotracheal intubation for critically ill COVID-19 patients admitted to intensive care units (ICUs).

Registry
clinicaltrials.gov
Start Date
November 17, 2020
End Date
June 10, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
St. Bortolo Hospital
Responsible Party
Principal Investigator
Principal Investigator

Silvia De Rosa

Principal Investigator

St. Bortolo Hospital

Eligibility Criteria

Inclusion Criteria

  • Critically ill patient above 18 year old, admitted in the Intensive Care of San Bortolo Hospital, Vicenza, and San Matteo Hospital, Pavia;
  • positive specimen for SARS-COV2 PCR;
  • tracheal intubation for respiratory distress related to SARS COV2 pneumonia

Exclusion Criteria

  • negative specimen for SARS-COV2 PCR
  • out of hospital intubation
  • intubation during cardiac arrest
  • intubation in the contest of general anesthesia for surgery

Outcomes

Primary Outcomes

Major adverse peri-intubation events

Time Frame: intubation procedure, an expected average 30 minutes

The incidence of major adverse peri-intubation events defined as least one events: * cardiovascular instability * severe Hypoxemia * cardiac arrest

Secondary Outcomes

  • Number of minor complications in the intubation process in patients admitted in the intensive care(28 days)
  • Correlation between videolaryngoscope use and incidence of complication compared to the conventional laryngoscopy(28 days)

Study Sites (2)

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