Early Versus Delayed Intubation of Patients With COVID-19

COVID-19 Clinical Trial

— EUDOCO  

Official title:

Effect of Early versUs Delayed intubatiOn on Clinical Outcomes of Patients With COVID-19 (EUDOCO): a Feasibility Randomized Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04632043
• Other study ID #: 32635, 13-10-2020
• Status: Terminated
• Phase: N/A
• Start date: November 18, 2020
• Est. completion date: March 15, 2021

Study information

• Verified date: February 2024
• Source: Evangelismos Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: March 15, 2021
• Est. primary completion date: March 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Hypoxemic Respiratory Failure
• COVID-19
• Respiratory Insufficiency

Intervention

Other:
• Endotracheal intubation
Endotracheal intubation

Locations

Country	Name	City	State
Greece	Evangelismos Hospital	Athens	Attiki

Sponsors (1)

Lead Sponsor	Collaborator
Evangelismos Hospital

Country where clinical trial is conducted

Greece, 

References & Publications (5)

Bauer PR, Gajic O, Nanchal R, Kashyap R, Martin-Loeches I, Sakr Y, Jakob SM, Francois B, Wittebole X, Wunderink RG, Vincent JL; ICON Investigators (Supplemental Appendix 1). Association between timing of intubation and outcome in critically ill patients: — View Citation

Fan E, Beitler JR, Brochard L, Calfee CS, Ferguson ND, Slutsky AS, Brodie D. COVID-19-associated acute respiratory distress syndrome: is a different approach to management warranted? Lancet Respir Med. 2020 Aug;8(8):816-821. doi: 10.1016/S2213-2600(20)303 — View Citation

Goyal P, Choi JJ, Pinheiro LC, Schenck EJ, Chen R, Jabri A, Satlin MJ, Campion TR Jr, Nahid M, Ringel JB, Hoffman KL, Alshak MN, Li HA, Wehmeyer GT, Rajan M, Reshetnyak E, Hupert N, Horn EM, Martinez FJ, Gulick RM, Safford MM. Clinical Characteristics of — View Citation

Kang BJ, Koh Y, Lim CM, Huh JW, Baek S, Han M, Seo HS, Suh HJ, Seo GJ, Kim EY, Hong SB. Failure of high-flow nasal cannula therapy may delay intubation and increase mortality. Intensive Care Med. 2015 Apr;41(4):623-32. doi: 10.1007/s00134-015-3693-5. Epub — View Citation

Marini JJ, Gattinoni L. Management of COVID-19 Respiratory Distress. JAMA. 2020 Jun 9;323(22):2329-2330. doi: 10.1001/jama.2020.6825. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from onset of severe acute hypoxemic respiratory failure to intubation	Difference in time from onset of severe acute hypoxemic respiratory failure to intubation between the two groups will be the primary (feasibility) outcome	28 days
Secondary	Organ failure-free 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	28 days
Secondary	Need for continuous renal replacement therapy		28 days
Secondary	Ventilator-free days		28 days
Secondary	ICU-free days	Intensive care unit-free days	28 days
Secondary	Mortality	All-cause ICU-mortality	28 days
Secondary	Number of severe post-intubation adverse events	Cardiac arrest and severe arterial desaturation (defined as SpO2 <80% for >5 minutes)	Within 30 minutes from intubation