Assessment of PaO2/FiO2 Ratio Pre and POst INTubation

NCT05853068 · tracked via the Priya Life Science Spain tracker

Sponsor

Hospital Universitario de Gran Canaria Doctor Negrín

Phase

Observational

Started

2023-04-29

Last updated

2025-08-26

Condition(s) studied

Acute Hypoxemic Respiratory Failure

Investigational drug(s) / intervention(s)

Mechanical ventilation

Mechanical ventilation: Need for endotracheal intubation and invasive mechanical ventilation

Study summary

We designed this study to dtermine whether invasive mechanical ventilation (MV) would have an impact on the reclassification of patients with acute hypoxemic respiratory failure (AHRF) -treated previously with non-invasive respiratory support- into categories of severity (mild, moderate, and severe). Our hypothesis is that the assessment of PaO2/FiO2 ratio on PEEP greater or equal to 5 cmH2O after intubation, in patients labeled as mild/moderate/severe AHRF while on non-invasive respiratory support, would identify that a marked proportion of patients would change the degree of severity after a brief period of invasive MV

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Patients meeting criteria for AHRF while they are on non-invasive respiratory support. * We will only include patients who had arterial blood gases (ABG) within a time-frame of the last 5 hours of NIV and the first 5 hours of invasive MV. * We will only include patients treated with high-flow oxygen nasal cannula (HFNC), or continuous positive airway pressure (CPAP), or bilevel positive pressure (BiPAP). Exclusion Criteria: * Patients who never required HFNC, or CPAP, or BiPAP before intubation. * Patients with no ABG during the last 5 hours of NIV before intubation. * Patients with no ABG during the first 5 hours after initiation of invasive MV. * Patients treated with inhaled pulmonary vasodilator only before or only after intubation.

Primary outcome measure(s)

Change in the degree of lung severity — 60 days
from severe/moderate to moderate/mild, from moderate/mild to mild after a brief period of invasive MV

Trial sites (2)

Facility	City	Region	Status
Rush University Medical Center	Chicago	Illinois
Jesús Villar	Las Palmas de Gran Canaria	Las Palmas

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05853068 on ClinicalTrials.gov ↗ ← All trials in Spain