Early Versus Delayed Intubation of Patients With COVID-19

NCT04632043 | Terminated

• 1 other identifier: 32635, 13-10-2020
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Acute Hypoxemic Respiratory Failure

Keywords

COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Organ failure-free days

  28 days

• Need for continuous renal replacement therapy

  28 days

• Ventilator-free days

  28 days

• ICU-free days

  28 days

• Mortality

  28 days

Study Arms (2)

Early intubation

ACTIVE COMPARATOR

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

Delayed intubation

ACTIVE COMPARATOR

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

Interventions

Endotracheal intubation OTHER

Endotracheal intubation

Delayed intubation; Early intubation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Evangelismos Hospital: lead

Study Sites (1)

Evangelismos Hospital

Athens, Attica, 10676, Greece

Location

Related Publications (5)

• 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.

  PMID: 32329799 RESULT

• 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)30304-0. Epub 2020 Jul 6.

  PMID: 32645311 RESULT

• 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 Covid-19 in New York City. N Engl J Med. 2020 Jun 11;382(24):2372-2374. doi: 10.1056/NEJMc2010419. Epub 2020 Apr 17. No abstract available.

  PMID: 32302078 RESULT

• 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: A secondary analysis of the ICON audit. J Crit Care. 2017 Dec;42:1-5. doi: 10.1016/j.jcrc.2017.06.010. Epub 2017 Jun 16.

  PMID: 28641231 RESULT

• 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 2015 Feb 18.

  PMID: 25691263 RESULT

MeSH Terms

Conditions

COVID-19; Respiratory Insufficiency

Interventions

Intubation, Intratracheal

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Intubation; Investigative Techniques

Study Officials

• Ilias Siempos, MD, DSc

  Evangelismos Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pulmonologist, Intensivist

Study Record Dates

• First Submitted: November 15, 2020
• First Posted: November 17, 2020
• Study Start: November 18, 2020
• Primary Completion: March 15, 2021
• Study Completion: March 15, 2021
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Within 3 months from publication
• Access Criteria: To anyone who is interested in writing a meta-analysis or review.

Locations

GR (1)