Tracheal Intubation in COVID-19 Patients

Sponsor
St. Bortolo Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04909476
Collaborator
Fondazione IRCCS Policlinico San Matteo di Pavia (Other)
143
2
6.7
71.5
10.6

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Procedure: Endotracheal intubation

Study Design

Study Type:
Observational
Anticipated Enrollment :
143 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Airways Management in COVID-19 Related Respiratory Failure: a Prospective Observational Multi-center Study
Actual Study Start Date :
Nov 17, 2020
Actual Primary Completion Date :
May 20, 2021
Anticipated Study Completion Date :
Jun 10, 2021

Arms and Interventions

Arm Intervention/Treatment
Severe COVID pneumonia with ET

Severe COVID 19 pneumonia undergoing endotracheal intubation

Procedure: Endotracheal intubation
Airways management in COVID 19 patients pneumonia

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 San Matteo Hospital Pavia Lombardia Italy 27100
2 San Bortolo Hospital Vicenza Veneto Italy 36100

Sponsors and Collaborators

  • St. Bortolo Hospital
  • Fondazione IRCCS Policlinico San Matteo di Pavia

Investigators

  • Principal Investigator: Lucia Cattin, MD, SBortolo Hospital
  • Principal Investigator: Silvia De Rosa, MD, SBortolo Hospital
  • Principal Investigator: Silvia Mongodi, MD, SMatteo Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Silvia De Rosa, Principal Investigator, St. Bortolo Hospital
ClinicalTrials.gov Identifier:
NCT04909476
Other Study ID Numbers:
  • 125/20
First Posted:
Jun 1, 2021
Last Update Posted:
Jun 4, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 4, 2021