Tracheal Intubation in COVID-19 Patients

• Conditions: Tracheal Intubation; COVID-19 Pneumonia
• Interventions: Procedure: Endotracheal intubation

• Registration Number: NCT04909476
• Lead Sponsor: St. Bortolo Hospital

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-17
• Primary Completion: 2021-05-20
• Study First Submitted: 2021-05-28
• Study First Submitted QC: 2021-05-28
• Status Verified: 2021-06
• Study First Posted: 2021-06-01
• Last Update Submitted: 2021-06-01
• Last Update Posted: 2021-06-04
• Study Completion: 2021-06-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 143

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Severe COVID pneumonia with ET	Endotracheal intubation	Severe COVID 19 pneumonia undergoing endotracheal intubation

Primary Outcome Measures

Name	Time	Method
Major adverse peri-intubation events	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 Outcome Measures

Name	Time	Method
Number of minor complications in the intubation process in patients admitted in the intensive care	28 days	This study will analyze the prevalence of minor complications related to intubation technique in the the Critical Unit. This information will be useful in order to determinate the risk factors associated.
Correlation between videolaryngoscope use and incidence of complication compared to the conventional laryngoscopy	28 days	Although the video laryngoscope is useful to perform difficult airways management, the benefits associated to its employment is still controversial compared to the conventional laringoscope.

Trial Locations

Locations (2)

San Bortolo Hospital; 🇮🇹 Vicenza, Veneto, Italy

San Matteo Hospital; 🇮🇹 Pavia, Lombardia, Italy