Clinical trial of noninvasive ventilator XVENT XVM20 FrontlinerTM
| ISRCTN | ISRCTN68812324 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68812324 |
- Submission date
- 03/07/2025
- Registration date
- 13/07/2025
- Last edited
- 11/07/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
Respiratory insufficiency is a condition where the lungs cannot adequately exchange gases. Non-invasive respiratory support plays a critical role in managing respiratory insufficiency, helping to reduce the need for invasive mechanical ventilation and its associated complications. In light of increasing clinical demands, especially in resource-limited settings, the development of reliable and cost-effective ventilator technologies is critical. The XVENT XVM20 FrontlinerTM is a domestically designed, non-invasive ventilator supporting both CPAP and BiPAP modes, produced by Xirka Dama Persada Ltd., Indonesia. The aim of this study is to test the effectiveness and safety of this device.
Who can participate:
Patients aged over 18 years with decreased peripheral oxygen saturation (less than 93%) and a respiratory rate between 28 and 30 breaths per minute
What does the study involve?
Patients were randomly assigned to receive either CPAP or BiPAP therapy using the XVENT XVM20 FrontlinerTM. Peripheral oxygen saturation, respiratory rate, heartbeat rate and blood pressure were monitored through attached sensors and recorded at baseline, every 15 minutes during 3 hours of observation, and every 2 hours in the next 51 hours. Patients’ comfort was also observed. Device-related parameters, including electrical, noise, temperature, pressure, and inspiratory/expiratory time stability, were also recorded at baseline, every 15 minutes during 3 hours of observation, and every 2 hours in the next 51 hours.
What are the possible benefits and risks of participating
Benefits:
Participants will receive free medical treatment for hypoxia and may be provided with financial compensation.
Potential risks:
1. Treatment failure, in which oxygenation does not improve within 2–3 hours of therapy initiation.
2. Discomfort or agitation experienced during the use of the non-invasive ventilation device.
Where is the study run from?
Advent Hospital (Indonesia)
When is the study starting and how long is it expected to run for?
July 2020 to October 2020
Who is funding the study?
This study was supported by Universitas Padjadjaran internal grant. Additional support was provided by Xirka Darma Persada Ltd. for equipment and technical resources. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Who is the main contact?
Reza Widianto Sudjud, reza.widianto.sudjud@unpad.ac.id
Contact information
Principal Investigator
Jalan Pasteur no. 38
Bandung
40161
Indonesia
 ORCID ID |
0000-0001-5966-4846 |
|---|---|
| Phone | +62 (0)813 2000 3010 |
| reza.widianto.sudjud@unpad.ac.id |
Public, Scientific
Jalan Pasteur no.38
Bandung
40161
Indonesia
| ORCID ID |
0000-0002-1907-9885 |
|---|---|
| Phone | +62 (0)857 9449 5885 |
| jenifer_kiem@yahoo.co.id |
Study information
| Study design | Single-blind equivalence two-arm parallel-group interventional study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Safety, Efficacy |
| Participant information sheet | https://drive.google.com/file/d/1WDcwe2xgvKOjngdYVsX0dnlheoKUSK91/view?usp=drive_link |
| Scientific title | Assessing the efficacy of X-VENT ventilation: a performance comparison with continuous positive airway pressure and bilevel positive airway pressure modes |
| Study objectives | 1. To evaluate the effect of the XVENT™ XMV20 Frontliner in continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) modes on: 1.1. Patient oxygenation levels (SpO₂) 1.2. Respiratory rate 1.3. Blood pressure 2. To assess the pressure stability of the device during use: 2.1. Positive end expiratory pressure (PEEP) in CPAP mode 2.2. Inhalation positive airway pressure (IPAP) and exhalation positive airway pressure (EPAP) in BiPAP mode 2.3. EPAP and IPAP duration in BiPAP mode 3. To evaluate patient comfort during the use of CPAP and BiPAP modes. 4. To assess the operational stability, noise level, and electrical performance of the XVENT™ XMV20 Frontliner during patient use in both CPAP and BiPAP modes. |
| Ethics approval(s) |
Approved 28/07/2020, Research Ethics Review Committee of Dr. Hasan Sadikin General Hospital (Jalan Pasteur no.38, Bandung, 40161, Indonesia; +62 (0)222034953; rsup@rshs.web.id), ref: LB.02.01/X.6.5/198/2020 |
| Health condition(s) or problem(s) studied | Desaturation (SpO₂ <95%) not requiring invasive ventilation |
| Intervention | 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 leakage. The CPAP and BiPAP settings were subsequently configured as follows: 1. Continuous Positive Airway Pressure (CPAP) Initial pressure was set at 5 cmH2O and FiO2 was adjusted to maintain SpO2 >95%. 2. Bi-level Positive Airway Pressure (BiPAP) The Inspiratory Positive Airway Pressure (IPAP) was set to 10 cmH₂O, and the Expiratory Positive Airway Pressure (EPAP) was set to 5 cmH₂O. The inspiratory-to-expiratory (I:E) ratio was configured at 1:2. The inspiratory time was set to 1.7 seconds, and the expiratory time to 3.5 seconds. Patients were randomly assigned to receive either CPAP or BiPAP therapy using computer-generated randomization based on hospital registration numbers, as performed by a statistician. An equal allocation ratio of 1:1 was applied to ensure balanced group sizes between the two treatment arms. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | XVENT XVM20 Frontliner |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 01/07/2020 |
| Completion date | 20/10/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | 20 |
| Total final enrolment | 20 |
| Key inclusion criteria | 1. Decreased oxygen saturation (SpO₂ <95%) 2. Respiratory rate 28 - 30 times per minute |
| Key exclusion criteria | 1. Moderate to severe impaired consciousness (Glasgow Coma Scale score < 13) 2. Severe tachycardia (heart rate >120 beats per minute) 3. Respiratory failure requiring invasive ventilation and admission to the Intensive Care Unit (ICU) |
| Date of first enrolment | 01/07/2020 |
| Date of final enrolment | 01/10/2020 |
Locations
Countries of recruitment
- Indonesia
Study participating centre
Bandung
40131
Indonesia
Sponsor information
Industry
Jl. Matraman I No.9, RT.15/RW.1, Kb. Manggis, Kec. Matraman
East Jakarta
13150
Indonesia
| Phone | +62 (0)21 819 8700 |
|---|---|
| info@xirkachipset.com | |
| Website | https://xirka.id/ |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- Padjadjaran University, UNPAD
- Location
- Indonesia
Results and Publications
| Intention to publish date | 06/07/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated and/or analyzed during the current study are not expected to be made available due to patient privacy concerns and institutional data protection policies. |
Editorial Notes
03/07/2025: Study's existence confirmed by the Research Ethics Review Committee of Dr. Hasan Sadikin General Hospital.
