Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: NIL: The clinical data collection does not involve the changes in the approved indication, it falls under the category of post-market surveillance to prospectively gather clinical data
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.The subjects belongs to the category of ASA1 physical status shall be included. (Note: ASA2 ASA3 ASA4 and ASA5 classified physical status subjects shall be included after the completion of the pilot phase).Subject or the legally authorized 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.Pregnant population shall be excluded
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessing the adequate patient oxygenation,ventilation and delivery of anesthetic gas mixtures in accordance with need of the subjectsthroughout the surgery. Determining the performance in terms of delivered parameters against the intended or set values for the specific subject condition. Determine the possible unknown adverse events,undesirable side effects associated with use of the device.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 |
|---|---|
| Assessing the patient reported outcomes from user,collection of feedback from user and investigatorTimepoint: 7days | — |
Countries
India
Contacts
Public ContactVasundhara R
Krishna Rajendra Hospital, Mysore
Outcome results
None listed