Tracheal Intubation in COVID-19 Patients

NCT ID: NCT04909476

Last Updated: 2021-06-04

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 143 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-11-17
• Study Completion Date: 2021-06-10

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).

Conditions

COVID-19 Pneumonia; Tracheal Intubation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Severe COVID pneumonia with ET

Severe COVID 19 pneumonia undergoing endotracheal intubation

Endotracheal intubation

Intervention Type: PROCEDURE

Airways management in COVID 19 patients pneumonia

Interventions

Endotracheal intubation

Airways management in COVID 19 patients pneumonia

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

Sponsor Role: collaborator

St. Bortolo Hospital

OTHER

Sponsor Role: lead

Responsible Party

Silvia De Rosa

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lucia Cattin, MD

Role: PRINCIPAL_INVESTIGATOR

SBortolo Hospital

Silvia De Rosa, MD

Role: PRINCIPAL_INVESTIGATOR

SBortolo Hospital

Silvia Mongodi, MD

Role: PRINCIPAL_INVESTIGATOR

SMatteo Hospital

Locations

San Matteo Hospital

Pavia, Lombardy, Italy

Site Status: RECRUITING

San Bortolo Hospital

Vicenza, Veneto, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Silvia De Rosa, MD

Role: CONTACT

silvia.derosa@aulss8.veneto.it

+393933098583

Facility Contacts

Silvia Mongodi, MD

Role: primary

S.Mongodi@smatteo.pv.it

+393491217156

Silvia De Rosa, MD

Role: primary

silvia.derosa@aulss8.veneto.it

+39 3933098583

References

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Reference Type: BACKGROUND

PMID: 32312571 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 22318634 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 28968525 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 32200400 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 21150574 (View on PubMed)

Cattin L, Ferrari F, Mongodi S, Pariani E, Bettini G, Daverio F, Donadello K, Polati E, Mojoli F, Danzi V, De Rosa S. Airways management in SARS-COV-2 acute respiratory failure: A prospective observational multi-center study. Med Intensiva. 2023 Mar;47(3):131-139. doi: 10.1016/j.medin.2022.07.002. Epub 2023 Feb 24.

Reference Type: DERIVED

PMID: 36855737 (View on PubMed)

Cattin L, Ferrari F, Mongodi S, Pariani E, Bettini G, Daverio F, Donadello K, Polati E, Mojoli F, Danzi V, De Rosa S. Airways management in SARS-COV-2 acute respiratory failure: A prospective observational multi-center study. Med Intensiva (Engl Ed). 2023 Mar;47(3):131-139. doi: 10.1016/j.medine.2022.08.005. Epub 2022 Aug 8.

Reference Type: DERIVED

PMID: 36155747 (View on PubMed)

Other Identifiers

125/20

Identifier Type: -

Identifier Source: org_study_id