To establish safety and performance of RespirAId R20 -mechanical ventilation device in Patients

â??A single-centre, open label study to establish the efficacy of mechanical ventilation device (RespirAID R20) designed for the purpose of providing breathing support for those patients who face difficulty in breathing.â??

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/10/028638

Enrollment

Registered

2020-10-26

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: O- Medical and Surgical

Interventions

Intervention1: RespirAID R20: Device type: Ventilator

Dose: Not Applicable

Frequency: Once

Duration of Therapy: 3 hours Control Intervention1: Standard Mechanical Ventilator: Device type: Ventilator

Frequency: Twice

Duration of Therapy: 1 hour before and 1 hour after Intervention with RespirAID R20

Eligibility

Inclusion criteria

Inclusion criteria: - Patients who require a mechanical ventilator postoperatively with normal lung characteristics. - Patients who are at least 18 years of age of all genders. - Patients for whom the consent has been received.

Exclusion criteria

Exclusion criteria: - Patients below 18 years and above 55years of age - Patients with hemodynamic instability - Patients with pre-existing respiratory conditions

Design outcomes

Primary

Measure	Time frame
Evaluation of the performance, effectiveness and efficacy of RespirAID R20 (Test Device)Timepoint: The heart rate, SpO2, NIBP, Rhythm of ECG, Peak Airway Pressure, EtCO2, Expiratory Tidal Volume, Respiratory Rate, Compliance of the patient will be checked at baseline (before), during and after putting the patient on the test device. Total duration of the study will be 5 hours which includes observation for 1 hour before, 3 hours during and 1 hour after putting the patient on the test device. The data will be analysed once 5 patients have completed the study.	—

Measure

Time frame

Evaluation of the performance, effectiveness and efficacy of RespirAID R20 (Test Device)Timepoint: The heart rate, SpO2, NIBP, Rhythm of ECG, Peak Airway Pressure, EtCO2, Expiratory Tidal Volume, Respiratory Rate, Compliance of the patient will be checked at baseline (before), during and after putting the patient on the test device. Total duration of the study will be 5 hours which includes observation for 1 hour before, 3 hours during and 1 hour after putting the patient on the test device. The data will be analysed once 5 patients have completed the study.

—

Secondary

Measure	Time frame
Assess the ease of use of this device for doctors and medical staff.Timepoint: At the end of the study	—

Countries

India

Contacts

Public ContactAsim Sheeraz

Yenepoya (Deemed to be University)

irfan@yenepoya.edu.in9740330452

Outcome results

None listed

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