Severe respiratory failure in patients with confirmed, suspected or probable Covid- 19 disease
Conditions
Interventions
Trade Name: INOmax 800 ppm mol/mol
Product Name: INOmax
Pharmaceutical Form: Medicinal gas, compressed
Sponsors
Oslo University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All criteria must apply Patients = 18 years of age at the time of inclusion and who are confirmed, suspected or probable cases of covid-19 based on WHO definitions and SpO2 =65 years) yes F.1.3.1 Number of subjects for this age range 54
Exclusion criteria
Exclusion criteria: Only one criterion needs to apply for exclusion: 1. Patients who after 3 mins of ventilation with 10 cm H2O PEEP + 100% O2 i.e. at time of allocation (t0), have a SpO2 <50%, or a reliable SpO2 is impossible to obtain 2. Patients in severe kidney failure or dialysis, 3. Known or suspected pregnancy based on information on the time of inclusion. 4. Hypersensitivity to the active substance (NO) or to the excipient (N2) 5. Cardiac arrest 6. Patient in prison or custody by police 7. Staff present in treatment situation known to be pregnant 8. Any reason why, in the opinion of the treating physician, it is probably in the best interest of the patient not to participate in the trial. Female participants under the age of 50 years will be asked explicitly about possible pregnancy. If this cannot be obtained from the patient, next of kin will be asked if present. Information regarding exclusion criteria 2, 3 and 4 will be obtained from bystanders, often relatives or friends present at time of inclusion. If no clear information is available, the physicians shall include or exclude based on his/her best judgment at the time of inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The overall objective of the study is to evaluate the clinical efficacy and safety of INO compared to standard treatment prior to and during emergency RSI in hypoxic patients with suspected or confirmed COVID-19;Secondary Objective: *Evaluate the safety of the intervention as compared to the control as assed by: Circulatory function, Kidney function , Hemoglobin function, Platelet count *Evaluate the clinical efficacy of INO compared to standard treatment on respiratory severity and length of specialized care *Evaluate the effect of INO on cardiac stress ;Primary end point(s): The primary outcome measure is the change in SpO2, and the null hypothesis is that there is no difference in the change in SpO2 following initiation of INO;Timepoint(s) of evaluation of this end point: five minutes after the allocation of treatment arm, with IMP being administered by bag/mask ventilation, with 100% oxygen at a flow of 10lite/minute and a Positive End Expiratory pressure of 10 centimeter water. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): SpO2 during Rapid Sequence Intubation (tRSI) SpO2 from t1 to End of intervention Number of patients with SpO2<50 from t1 to End of intervention Respiratory rate from t0 to tRSI or End of intervention PaO2 at t0 to End of intervention Cardiac arrest during intervention GOS-E score on day 28 Mortality Secondary Heart rate at t0-tn Blood pressure at t0 to tn Increase in Serum urea concentration KDIGO AKI Stage up to day 28 Arterial MetHgb concentration Platelet count Need for INO after End of intervention ;Timepoint(s) of evaluation of this end point: At specified time point between allocation and end of intervention, which is when inhaled nitric oxide on INOBlender is stopped. Secondary end points also evaluated at day 28 after allocation | — |
Countries
Norway
Contacts
Public ContactAir Ambulance Department
Oslo University Hospital
Outcome results
None listed