NCT04909476

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).

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
143

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

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

November 17, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2021

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

May 28, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 1, 2021

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2021

Completed
Last Updated

June 4, 2021

Status Verified

June 1, 2021

Enrollment Period

6 months

First QC Date

May 28, 2021

Last Update Submit

June 1, 2021

Conditions

COVID-19 PneumoniaTracheal Intubation

Outcome Measures

Primary Outcomes (1)

  • Major adverse peri-intubation events

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

    intubation procedure, an expected average 30 minutes

Secondary Outcomes (2)

  • 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 Arms (1)

Severe COVID pneumonia with ET

Severe COVID 19 pneumonia undergoing endotracheal intubation

Procedure: Endotracheal intubation

Interventions

Endotracheal intubationPROCEDURE

Airways management in COVID 19 patients pneumonia

Severe COVID pneumonia with ET

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Critically ill patient above 18 year old, admitted in the Intensive Care

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

San Matteo Hospital

Pavia, Lombardy, 27100, Italy

RECRUITING

San Bortolo Hospital

Vicenza, Veneto, 36100, Italy

RECRUITING

Related Publications (7)

  • Yao W, Wang T, Jiang B, Gao F, Wang L, Zheng H, Xiao W, Yao S, Mei W, Chen X, Luo A, Sun L, Cook T, Behringer E, Huitink JM, Wong DT, Lane-Fall M, McNarry AF, McGuire B, Higgs A, Shah A, Patel A, Zuo M, Ma W, Xue Z, Zhang LM, Li W, Wang Y, Hagberg C, O'Sullivan EP, Fleisher LA, Wei H; collaborators. Emergency tracheal intubation in 202 patients with COVID-19 in Wuhan, China: lessons learnt and international expert recommendations. Br J Anaesth. 2020 Jul;125(1):e28-e37. doi: 10.1016/j.bja.2020.03.026. Epub 2020 Apr 10.

    PMID: 32312571BACKGROUND

  • Carrillo A, Gonzalez-Diaz G, Ferrer M, Martinez-Quintana ME, Lopez-Martinez A, Llamas N, Alcazar M, Torres A. Non-invasive ventilation in community-acquired pneumonia and severe acute respiratory failure. Intensive Care Med. 2012 Mar;38(3):458-66. doi: 10.1007/s00134-012-2475-6. Epub 2012 Feb 9.

    PMID: 22318634BACKGROUND

  • Huang HB, Peng JM, Weng L, Liu GY, Du B. High-flow oxygen therapy in immunocompromised patients with acute respiratory failure: A review and meta-analysis. J Crit Care. 2018 Feb;43:300-305. doi: 10.1016/j.jcrc.2017.09.176. Epub 2017 Sep 22.

    PMID: 28968525BACKGROUND

  • Goh KJ, Choong MC, Cheong EH, Kalimuddin S, Duu Wen S, Phua GC, Chan KS, Haja Mohideen S. Rapid Progression to Acute Respiratory Distress Syndrome: Review of Current Understanding of Critical Illness from Coronavirus Disease 2019 (COVID-19) Infection. Ann Acad Med Singap. 2020 Mar 16;49(3):108-118.

    PMID: 32200400BACKGROUND

  • Martin LD, Mhyre JM, Shanks AM, Tremper KK, Kheterpal S. 3,423 emergency tracheal intubations at a university hospital: airway outcomes and complications. Anesthesiology. 2011 Jan;114(1):42-8. doi: 10.1097/ALN.0b013e318201c415.

    PMID: 21150574BACKGROUND

  • 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.

    PMID: 36855737DERIVED

  • 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.

    PMID: 36155747DERIVED

MeSH Terms

Interventions

Intubation, Intratracheal

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsIntubationInvestigative Techniques

Study Officials

  • Lucia Cattin, MD

    SBortolo Hospital

    PRINCIPAL INVESTIGATOR

  • Silvia De Rosa, MD

    SBortolo Hospital

    PRINCIPAL INVESTIGATOR

  • Silvia Mongodi, MD

    SMatteo Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Silvia De Rosa, MD

CONTACT

+393933098583silvia.derosa@aulss8.veneto.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 28, 2021

First Posted

June 1, 2021

Study Start

November 17, 2020

Primary Completion

May 20, 2021

Study Completion

June 10, 2021

Last Updated

June 4, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

IT(2)