Health Condition 1: J069- Acute upper respiratory infection,unspecified Health Condition 2: J953- Chronic pulmonary insufficiency following surgery Health Condition 3: J709- Respiratory conditions due to unspecified external agent Health Condition 4: J969- Respiratory failure, unspecified Health Condition 5: J689- Unspecified respiratory conditiondue to chemicals, gases, fumes and vapors
Conditions
Interventions
Intervention1: NA: NA
Control Intervention1: NA: NA
Sponsors
Skanray Technologies Limited
Eligibility
Inclusion criteria
Inclusion criteria: Adult and pediatric subjects of age more than two year or body weight of 10 kg above whichever is lower and of either gender. Subjects who need mechanical ventilation. Subject or the legally authorised representative on behalf of subject shall be capable of understanding and signing the informed consent form.
Exclusion criteria
Exclusion criteria: Subjects with age less than two year or less than 10 kg of body weight. Subjects who need ventilation during transport. Pregnant or nursing mother. Unconscious subjects shall be excluded from the non invasive mode of ventilation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determining the performance in terms of delivered parameters against the intended or set values for the specific subject condition.Timepoint: Every 4 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Collection of feedback which includes investigator’s assessment of the overall safety and performance of the SkanRespiro Plus and Pranaa. Collection of feedback from the user reflecting the ease of ventilation and usability. The collection of evidence reflecting the subject ventilation Timepoint: Every seventh day or earlier | — |
Countries
India
Contacts
Public ContactVasundhara R
Narayana Health MICU Mazumdar Shaw Medical Center
Outcome results
None listed