Inhaled Nitric Oxide As A Bridge To Mechanical Ventilation In Patients With Suspected Covid-19 Respiratory Failure - INOCOV-19

Oslo University Hospital0 个研究点目标入组 54 人开始时间: 2020年4月24日最近更新: 2021年11月8日

试验速览

暂无简介。

•All criteria must apply
•Patients = 18 years of age at the time of inclusion
•who are confirmed, suspected or probable cases of covid-19 based on WHO definitions
•SpO2 <90% after 3 minutes 10 cm H2O PEEP + 100% O2
•who are treated by a physician who have specifically undergone formal training in pre-hospital INO administration and the present protocol.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 54
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 54

•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.

发起方

Oslo University Hospital