Actively Recruiting

Age: 18Years +
All Genders
ID06757166

Effects of Early Versus Delayed Endotracheal Intubation on Outcomes in COVID-19 Related Hypoxemic Respiratory Failure An Observational Study of Timing Impact on Invasive Mechanical Ventilation

Led by Erasmus Medical Center · Updated on 2025-01-03

50000

Participants Needed

1

Research Sites

365 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating whether early endotracheal intubation compared to late intubation affects clinical outcomes in patients with hypoxemic respiratory failure, particularly in those related to COVID-19. The study focuses on whether delaying invasive mechanical ventilation after a period of non-invasive respiratory support, such as high-flow nasal oxygen or non-invasive ventilation, influences the duration of mechanical ventilation or mortality. This research aims to identify optimal thresholds of oxygenation and respiratory rate for initiating intubation to improve survival or reduce ventilation time without harming patients. The study compares 25 different treatment strategies defined by combinations of oxygen saturation-to-fraction of inspired oxygen (S/F) ratios and respiratory rate thresholds. Early intubation corresponds to higher S/F ratios and lower respiratory rates, while late intubation corresponds to lower S/F ratios and higher respiratory rates. Sensitivity analyses will examine effects in patients without high carbon dioxide levels and adjust for neurological status. Subgroup analyses will consider patients with COVID-19, COPD, congestive heart failure, different body mass indexes, and those receiving high-flow nasal oxygen or non-invasive ventilation at the study start. Participants are hospitalized adults with hypoxemic respiratory failure who have not yet been intubated. Researchers will monitor outcomes including 28-day mortality and time on invasive mechanical ventilation. The study will collect clinical data to assess the risks and benefits of early versus delayed intubation strategies. The total participation duration includes monitoring these outcomes up to 28 days after treatment initiation.

CONDITIONS

Official Title

The Effect of NOn-invasive Respiratory Support on outcoMe and Its Risks in SARS-COV-2-related Hypoxemic Respiratory Failure

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Hospitalized (inpatient or ICU)
  • 18 years or older
  • Hypoxemic respiratory failure: S/F<250
  • Not yet intubated
Not Eligible

You will not qualify if you...

  • Do not intubate order
  • Presence of tracheostomy

AI-Screening

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Trial Site Locations

Total: 1 location

1

Erasmus Medical Centre

Rotterdam, South Holland, Netherlands, 3015GD

Actively Recruiting

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Research Team

C

Carmen A.T. Reep, MSc

E

Evert-Jan Wils, PhD, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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