Assessment of PaO2/FiO2 Ratio Pre and POst INTubation

NCT05853068 | Active Not Recruiting

• 1 other identifier: 2022-161-1
• Study Type: observational
• Target: 400
• Locations: 2 countries
• Sites: 2

Brief 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

Conditions

Acute Hypoxemic Respiratory Failure

Keywords

acute respiratory failure; non-invasive ventilatory support; mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• Change in the degree of lung severity

  from severe/moderate to moderate/mild, from moderate/mild to mild after a brief period of invasive MV

  60 days

Study Arms (1)

Patients on non-invasive ventilatory support to IMV

Patients with AHRF treated with non-invasive ventilatory support \[for the purpose of this study we included High-flow nasal cannula (HFNC), continuous positive airway pressure (CPAP), and non-invasive ventilation (NIV)\] who required endotracheal intubation and invasive mechical ventilation.

Device: Mechanical ventilation

Interventions

Mechanical ventilation DEVICE

Need for endotracheal intubation and invasive mechanical ventilation

Patients on non-invasive ventilatory support to IMV

Eligibility Criteria

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

Study Population

Patients with AHRF (defined as PaO2/FiO2 lower or equal to 300 mmHg and FiO2 greater or equal to 0.3, on non-invasive ventilatory support) prior to intubation.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Negrin University Hospital: lead
• Rush University Medical Center: collaborator

Study Sites (2)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Jesús Villar

Las Palmas de Gran Canaria, Las Palmas, 35003, Spain

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Respiration, Artificial

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Resuscitation; Emergency Treatment; Respiratory Therapy

Study Officials

• Jesús Villar

  Hospital Universitario D. Negrin

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: May 10, 2023
• Study Start: April 29, 2023
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); US (1)