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Evaluation of Non Invasive Ventilator

Evaluation of the SwasthVayu- Bi level Positive Airway Pressure system

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/07/026607
Enrollment
10
Registered
2020-07-15
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J439- Emphysema, unspecified

Interventions

Intervention1: BiPAP Auto Biflex Philips Respironics IN761S: BiPAP Machine manufactured by Philips has modes CPAP and BiPAP with spontaneous modes. SwasthVayu has few additional modes like Spontaenous

Sponsors

CSIR National Aerospace Laboratories
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. pH being less than 7.25 or respiratory acidosis with CO2 retention. 2. Use of accessory muscles of respiration, increased work of breathing, paradoxical respiration, retraction of intercostal muscles. 3. Persistent hypoxemia despite using supplemental oxygen

Exclusion criteria

Exclusion criteria: 1. Unable to tolerate NIV 2. Diminished consciousness, psychomotor agitation inadequately controlled by sedation 3. Massive aspiration or persistent vomiting. 4. Persistent inability to remove respiratory secretions. 5. Severe hemodynamic instability without response to fluids or vasoactive drugs. 6. Severe ventricular or supraventricular arrhythmia. 7. Status post cardiac arrest or respiratory arrest. 8. Life threatening hypoxia in a patient unable to tolerate NIV

Design outcomes

Primary

MeasureTime frame
improvement in oxygenation Improvement in hypoxia improvement in hypercarbiaTimepoint: Immediately after the trial of 120 mins for each patient

Secondary

MeasureTime frame
improvement in oxygenationTimepoint: Immediately after the trial of 120 mins for each patient

Countries

India

Contacts

Public ContactDr Sathyanarayana Mysore

Manipal Hospital

satya.mysore@manipalhospitals.com9741303009

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026