Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: NA: NA
Control Intervention1: NA: NA
Sponsors
Skanray Technologies Limited
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. Subject or the legally authorised representative on behalf of the 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determining the safety and performance in terms of delivered parameters against the intended or set values for the specific subject condition. The ventilatory, vital physiological and anesthesia gas monitoring parameters should be evaluated.Timepoint: For 60 minutes surgery: 0,12,24,36,48,60th minute. For 120 minutes surgery: 0,24,48,72,96,120th minute. For 360 minutes surgery: 0, 36,72,108,144,180 minute. | — |
Secondary
| Measure | Time frame |
|---|---|
| Collection of feedback from the user /investigator reflecting the ease of delivering the anesthetic gas mixture, ventilatory support and usability. Collection of feedback which includes the investigators assessment of the overall safety and performance of the Skanrayâ??s Anesthetic Workstations. The collection of evidence reflecting the delivery of anaesthetic gas mixture and ventilatory support. Timepoint: Within 7 days after completing the general anesthesia procedure. | — |
Countries
India
Contacts
Public ContactVasundhara R
Narayana Institute of Cardiac Sciences
Outcome results
None listed