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The Effect of FiO2 on PaO2/FiO2 Ratio

The Effect of Inspiratory Oxygen Fraction on the Ratio of Partial Arterial Oxygen Pressure and Inspiratory Oxygen Fraction (PaO2/FiO2 Ratio) in Mechanically Ventilated Patients With and Without Mild to Moderate ARDS

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03156218
Enrollment
20
Registered
2017-05-17
Start date
2017-09-01
Completion date
2020-08-01
Last updated
2019-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PaO2/FiO2 Ratio

Keywords

PaO2/FiO2 ratio, hyperoxia, mechanical ventilation, ARDS

Brief summary

The PaO2/FiO2 ratio is frequently used to determine the severity of lung injury in mechanically ventilated patients. However, several mathematical models have shown that PaO2/FiO2 ratio depends on FiO2. The relationship is complex and depends on numerous physiological variables, including shunt fraction, and arterio-venous oxygen difference. The nonlinear relation between PaO2/FiO2 and FiO2 underlines the limitations describing the intensity of hypoxemia using PaO2/FiO2 and is thus of major importance for the clinician. Surprisingly, this relationship has only been assessed mathematically. Obviously, the accuracy of the mathematical relationship depends on the input variables used. The current study is designed to assess the PaO2/FiO2 vs FiO2 relation in mechanically ventilated patients without ARDS (n =10) and with mild or moderate ARDS (n =10). In order to explain the dependency of the PaO2/FiO2 on FiO2, shunt fraction and alveolar - arterial oxygen difference ((A-a)DO2) will be determined in these patients.

Detailed description

Rationale: The PaO2/FiO2 ratio is frequently used to determine the severity of lung injury in mechanically ventilated patients. However, several mathematical models have shown that PaO2/FiO2 ratio depends on FiO2. The relationship is complex and depends on numerous physiological variables, including shunt fraction, and arterio-venous oxygen difference. The nonlinear relation between PaO2/FiO2 and FiO2 underlines the limitations describing the intensity of hypoxemia using PaO2/FiO2 and is thus of major importance for the clinician. Surprisingly, this relationship has only been assessed mathematically. Obviously, the accuracy of the mathematical relationship depends on the input variables used. The current study is designed to assess the PaO2/FiO2 vs FiO2 relation in mechanically ventilated patients without ARDS (n =10) and with mild or moderate ARDS (n =10). In order to explain the dependency of the PaO2/FiO2 on FiO2, shunt fraction and alveolar - arterial oxygen difference ((A-a)DO2) will be determined in these patients. Objective: To study the relation between PaO2/FiO2-ratio and FiO2 Study design: An unblinded, prospective, interventional study Study population: Mechanically ventilated patients \> 18 years, admitted to the Intensive Care Unit of VU-Medical Center post cardiac surgery without ARDS (n = 10) and with mild to moderate ARDS (n = 10). Intervention: Two interventions will be performed: 1. Modulation of FiO2: FiO2 will be reduced to 21% or until peripheral oxygen saturation of 92%, whatever occurs first. Subsequently FiO2 will be increased up to 100%. 2. Withdrawal of blood: Blood will be withdrawn from the indwelling arterial line and pulmonary artery catheter. No catheters will be inserted for the study. The maximum number of time points is 7. At each time point 1.5 ml of blood will be withdrawn from both the arterial and pulmonary artery catheter for blood gas analysis. At the start and the end of the study period 2 additional blood samples of 5 ml each will be drawn. Accordingly, the maximum amount of blood obtained will be less than 50 ml. Main study parameters/endpoints: At each level of FiO2 the following parameters will be assessed: * Arterial blood gas analysis, including SaO2 * Central Venous oxygen saturation and content * Hemoglobin * Body temperature * End tidal CO2 * VO2 and VCO2 * Ventilatory parameters (tidal volume, respiratory rate, Ppeak Paw) * Hemodynamics (Bloodpressure and Heart Rate)

Interventions

DRUGModulation of FiO2

Modulation of FiO2: FiO2 will be reduced to 21% or until peripheral oxygen saturation of 92%, whatever occurs first. Subsequently FiO2 will be increased up to 100%.

Sponsors

Amsterdam UMC, location VUmc
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

In both groups FiO2 will be modulated: FiO2 will be reduced to 21% or until peripheral oxygen saturation of 92%, whatever occurs first. Subsequently FiO2 will be increased up to 100%.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

All mechanically ventilated patients, admitted to the Intensive Care Unit of VU-Medical Center post cardiac surgery without ARDS and with mild to moderate ARDS. In order to be eligible to participate in this study, a subject must meet all of the following criteria: * Mechanically ventilated patients * Stable hemodynamics * Stable haemoglobin level * Stable body temperature * Stable level of sedation * Pulmonary-Artery and Artery catheter

Exclusion criteria

* Incomplete revascularization after CABG * Cardiac ischemia * Neurotrauma

Design outcomes

Primary

MeasureTime frameDescription
The effect of FiO2 on the PaO2/FiO2-ratio2 hoursTo study the effect of FiO2 on the PaO2/FiO2-ratio in mechanically ventilated patients post cardiac surgery without ARDS and with mild to moderate ARDS

Secondary

MeasureTime frameDescription
Shunt fraction, arteriovenous oxygen difference and alveolar - arterial oxygen difference2 hoursShunt fraction, arteriovenous oxygen difference and alveolar - arterial oxygen difference will be determined to explain the relationship between FiO2 and the PaO2/FiO2-ratio

Countries

Netherlands

Contacts

Primary ContactAngelique Spoelstra - de Man, MD, PhD
am.spoelstra@vumc.nl+31204443924
Backup ContactLeo Heunks, MD, PhD
l.heunks@vumc.nl+31204443924

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026