To study the relation between PaO2/FiO2-ratio and FiO2
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
De PaO2/FiO2 ratio wordt bestudeerd
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The relationship between FiO2 and PaO2/FiO2-ratio
Secondary outcome
Shunt fraction, arteriovenous oxygen difference and alveolar - arterial oxygen
difference will be determined in these patients to explain the relationship
between FiO2 and the PaO2/FiO2-ratio
Background 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
clinical practice.
Study objective
To study the relation between PaO2/FiO2-ratio and FiO2
Study design
An unblinded, prospective, interventional study
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 Withdrawal of blood: Blood will be withdrawn from the indwelling arterial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blood will be withdrawn from both the arterial and pulmonary artery catheter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.
Study burden and risks
The risk and burden for study subjects is negligible. Blood will be withdrawn
from the indwelling arterial line and the pulmonary artery catheter. The
insertion of arterial and pulmonary artery catheters are part of standard ICU
care. Pulmonary artery catheters will not be inserted just for the purpose of
the study. The maximum amount of blood obtained will be less than 50 ml. This
limited amount of blood will not result in adverse events for the patients
participating. For individual patients no benefits are expected.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
Mechanically ventilated patients, admitted to the ICU, without ARDS or with mild (200 mmHg < PaO2/FIO2 <=300 mmHg with PEEP >=5 cmH2O) to moderate (100 mmHg < PaO2/FIO2 <=200 mmHg with PEEP >=5 cmH2O) ARDS (according to the Berlin criteria):
• 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
• Severe ARDS (PaO2/FIO2 <=100 mmHg with PEEP >=5 cmH2O)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2017-002022-20-NL |
| ClinicalTrials.gov | NCT03156218 |
| CCMO | NL61945.029.17 |