Desaturation (SpO2 <95%) not requiring invasive ventilation Respiratory
Conditions
Interventions
Initially, the XVENT™ XMV20 Frontliner was connected to an oxygen source with a flow rate of 15 L/min. A nasal mask was then applied to the patient, ensuring a tight yet comfortable fit without air le
Sponsors
Xirka Dama Persada Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Decreased oxygen saturation (SpO2 <95%) 2. Respiratory rate 28 - 30 times per minute
Exclusion criteria
Exclusion criteria: 1. Moderate to severe impaired consciousness (Glasgow Coma Scale score 120 beats per minute) 3. Respiratory failure requiring invasive ventilation and admission to the Intensive Care Unit (ICU)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Peripheral oxygen saturation (SpO2) measured using a finger pulse oximeter at baseline, every 15 minutes during the first 3 hours and every 2 hours for the subsequent 51 hours, resulting in a total observation period of 54 hours 2. Respiratory rate measured using XVENT XVM20 FrontlinerTM flow sensor, displayed on the device’s monitor at baseline, every 15 minutes during the first 3 hours and every 2 hours for the subsequent 51 hours, resulting in a total observation period of 54 hours 3. Blood pressure measured using an external pressure sensor at baseline, every 15 minutes during the first 3 hours and every 2 hours for the subsequent 51 hours, resulting in a total observation period of 54 hours 4. Heartbeat rate measured using external pulse sensor at baseline, every 15 minutes during the first 3 hours and every 2 hours for the subsequent 51 hours, resulting in a total observation period of 54 hours 5. Patient comfort assessed using a 5-point Agitation Numeric Scale, where a score of 1 indicated very uncomfortable and agitated, and a score of 5 indicated very comfortable and relaxed at baseline, every 15 minutes during the first 3 hours and every 2 hours for the subsequent 51 hours, resulting in a total observation period of 54 hours 6. Adverse events recorded during the experiment and 1 day after the experiment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Electrical stability, assessed by observing for any unexpected power loss or shutdown during device operation at baseline, every 15 minutes during the first 3 hours and every 2 hours for the subsequent 51 hours, resulting in a total observation period of 54 hours 2. Noise stability, evaluated based on whether the device generates excessive or abnormal noise during use at baseline, every 15 minutes during the first 3 hours and every 2 hours for the subsequent 51 hours, resulting in a total observation period of 54 hours 3. Temperature stability, determined by monitoring for any sudden increase in device temperature due to inadequate heat dissipation at baseline, every 15 minutes during the first 3 hours and every 2 hours for the subsequent 51 hours, resulting in a total observation period of 54 hours 4. Pressure delivery stability, assessed by verifying whether the device consistently delivers the desired CPAP/EPAP and IPAP pressures over time at baseline, every 15 minutes during the first 3 hours and every 2 hours for the subsequent 51 hours, resulting in a total observation period of 54 hours 5. Inspiratory and expiratory time stability, evaluated by checking whether the device accurately delivers IPAP and EPAP according to the preset inspiratory and expiratory durations at baseline, every 15 minutes during the first 3 hours and every 2 hours for the subsequent 51 hours, resulting in a total observation period of 54 hours | — |
Countries
Indonesia
Contacts
Public ContactJenifer Kiem Aviani
Outcome results
None listed