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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.
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:
Main study parameters/endpoints:
At each level of FiO2 the following parameters will be assessed:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Without ARDS | Experimental | Patients admitted to the ICU after cardiac surgery with a PaO2/FiO2 ratio > 300. 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%. |
|
| With mild to moderate ARDS | Experimental | Patients admitted to the ICU after cardiac surgery with a PaO2/FiO2 ratio > 100 and < 300. 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%. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modulation of FiO2 | Drug | 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%. |
| Measure | Description | Time Frame |
|---|---|---|
| The effect of FiO2 on the PaO2/FiO2-ratio | To 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 | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Shunt fraction, arteriovenous oxygen difference and alveolar - arterial oxygen difference | Shunt fraction, arteriovenous oxygen difference and alveolar - arterial oxygen difference will be determined to explain the relationship between FiO2 and the PaO2/FiO2-ratio | 2 hours |
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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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Angelique Spoelstra - de Man, MD, PhD | Contact | +31204443924 | am.spoelstra@vumc.nl | |
| Leo Heunks, MD, PhD | Contact | +31204443924 | l.heunks@vumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Angelique Spoelstra - de Man, MD, PhD | Amsterdam UMC, location VUmc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VU University Medical Center | Recruiting | Amsterdam | 1081 HV | Netherlands |
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| ID | Term |
|---|---|
| D018496 | Hyperoxia |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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%.
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