An Open-Label, Prospective, Single-Center, Proof Of Concept Study To Assess The Efficacy And Safety Of VENTIPEEPTM In Stabilizing The Oxygen Levels In Patients With ARDS

Flextool equipment pvtltd0 个研究点目标入组 50 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1.Written signed and dated informed consent (patient or LAR).
•2.Both genders, aged >=18 to <=65 years,
•3.Patients with ARDS including COVID-19 patients
•4.SpO2>=90% for adults and respiratory rate <= 30/minute
•5.Patient in the opinion of the investigator requires the use of Ventipeep oxygen mask
•6.BMI <30 kg/m2
•7.Patients who provide a agree to abide by the study requirements

•1.Pregnant and lactating women
•2.Children <18 yrs. of age; elderly >65 years
•3.SpO2 >80 for adults and respiratory rate <20/minute
•4.Patients having known tendency to nausea/vomiting or pharyngeal pathology
•5.Planned Tracheal intubation
•6.Patients known to have Gastro-Esophageal Reflux Disease (GERD), hiatus hernia or previous upper gastrointestinal tract surgery
•7.Need for direct admission to the intensive care unit for mechanical ventilation
•8.Underlying chronic obstructive pulmonary disease stage III-IV
•9.Patients simultaneously participating in another clinical study.
•10.Speech or swallowing impairment (risk of aspiration)
•11.History of stroke with significant neurologic deficit.
•12.Recent heart or lung surgery within 3 months
•13.Medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
•14.A subject who is judged by the investigator as inappropriate to participate in the study for any reason other than those mentioned above.

发起方

Flextool equipment pvtltd