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Early Versus Delayed Intubation of Patients With COVID-19 (EUDOCO)

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ClinicalTrials.gov Identifier: NCT04632043
Recruitment Status : Recruiting
First Posted : November 17, 2020
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
Ilias Siempos, Evangelismos Hospital

Brief Summary:

Although management of acute hypoxemic respiratory failure associated with coronavirus disease 2019 (COVID-19) often includes mechanical ventilation, the optimal timing of initiation of invasive mechanical ventilation remains unknown.

We hypothesise that a randomized controlled trial comparing early intubation as opposed to delayed intubation among patients with COVID-19 suffering from severe acute hypoxemic respiratory failure is feasible.


Condition or disease Intervention/treatment Phase
COVID-19 Acute Hypoxemic Respiratory Failure Other: Endotracheal intubation Not Applicable

Detailed Description:

A common manifestation of COVID-19 is severe acute hypoxemic respiratory failure. Management of acute hypoxemic respiratory failure associated with COVID-19 often includes mechanical ventilation. The optimal timing of initiation of invasive mechanical ventilation remains unknown.

On the one hand, early initiation of invasive mechanical ventilation (i.e. early endotracheal intubation) has been advocated as a means to reduce subsequent possible aerosolization of the virus, as would happen by alternate means of oxygenation/ventilation allowing air leaks. Also, early intubation may prevent the induction of self-inflicted lung injury in patients who breath spontaneously and have high respiratory drive and, therefore, large transpulmonary pressure swings. On the other hand, delaying intubation, by trying alternate means of oxygenation/ventilation, may mean that some of the patients may not be intubated at all and therefore will be protected from the adverse events of invasive mechanical ventilation (such as ventilator-induced lung injury, ventilator-associated pneumonia and ventilator-induced diaphragmatic dysfunction). The latter strategy may also address the unavailability of enough ventilators to meet the increased demand of treating patients with COVID-19.

Given that no randomized controlled trials are currently available to guide clinical practice regarding optimal timing of intubation, we propose a single-center randomized controlled feasibility trial to compare early intubation versus delayed intubation among patients with COVID-19 suffering from severe acute hypoxemic respiratory failure. The aim is that we gain experience and produce pilot data, which could inform the design of a subsequent large multi-center clinical trial.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Early versUs Delayed intubatiOn on Clinical Outcomes of Patients With COVID-19 (EUDOCO): a Feasibility Randomized Controlled Trial
Actual Study Start Date : November 18, 2020
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Early intubation
Patients with COVID-19 suffering from severe acute hypoxemic respiratory failure (defined as the need for non-rebreather mask or high flow nasal oxygen with setting FiO2 of at least 90% or non-invasive mechanical ventilation to maintain a SpO2 >92%) for at least 48 hours will undergo intubation.
Other: Endotracheal intubation
Endotracheal intubation

Active Comparator: Delayed intubation
Patients with COVID-19 suffering from severe acute hypoxemic respiratory failure (defined as the need for non-rebreather mask or high flow nasal oxygen with setting FiO2 of at least 90% or non-invasive mechanical ventilation to maintain a SpO2 >92%) for at least 48 hours will continue to receive non-rebreather mask, high-flow nasal oxygen or non-invasive mechanical ventilation in an attempt to avoid intubation.
Other: Endotracheal intubation
Endotracheal intubation




Primary Outcome Measures :
  1. Time from onset of severe acute hypoxemic respiratory failure to intubation [ Time Frame: 28 days ]
    Difference in time from onset of severe acute hypoxemic respiratory failure to intubation between the two groups will be the primary (feasibility) outcome


Secondary Outcome Measures :
  1. Organ failure-free days [ Time Frame: 28 days ]
    Number of days without the need for invasive mechanical ventilation, vasopressors and continuous renal replacement therapy with days after death not to be considered as organ failure-free days

  2. Need for continuous renal replacement therapy [ Time Frame: 28 days ]
  3. Ventilator-free days [ Time Frame: 28 days ]
  4. ICU-free days [ Time Frame: 28 days ]
    Intensive care unit-free days

  5. Mortality [ Time Frame: 28 days ]
    All-cause ICU-mortality

  6. Number of severe post-intubation adverse events [ Time Frame: Within 30 minutes from intubation ]
    Cardiac arrest and severe arterial desaturation (defined as SpO2 <80% for >5 minutes)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Adult patients with confirmed COVID-19 and severe acute hypoxemic respiratory failure

Exclusion Criteria:

  • Postoperative acute respiratory failure (within one week from surgery)
  • After cardiac arrest
  • Chronic hypoxemic respiratory failure
  • Hypercapnic respiratory failure
  • No full code
  • Lack of equipoise of the clinical team
  • Lack of informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04632043


Contacts
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Contact: Ilias Siempos, MD, DSc +306948279049 isiempos@yahoo.com

Locations
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Greece
Evangelismos Hospital Recruiting
Athens, Attiki, Greece, 10676
Contact: Ilias Siempos, MD, DSc    +306948279049    isiempos@yahoo.com   
Sponsors and Collaborators
Evangelismos Hospital
Investigators
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Principal Investigator: Ilias Siempos, MD, DSc Evangelismos Hospital
Publications of Results:
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Responsible Party: Ilias Siempos, Pulmonologist, Intensivist, Evangelismos Hospital
ClinicalTrials.gov Identifier: NCT04632043    
Other Study ID Numbers: 32635, 13-10-2020
First Posted: November 17, 2020    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Within 3 months from publication
Access Criteria: To anyone who is interested in writing a meta-analysis or review.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ilias Siempos, Evangelismos Hospital:
COVID-19
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases