Clinical Efficacy of the Indigenously Developed Oxygen delivery device : A Pilot Study

Clinical Efficacy of the Indigenously Developed High Flow Nasal Cannula Device (TrueOxy+ HFNC Device): A Pilot Study - NIL

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/02/062209

Enrollment

Registered

2024-02-01

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

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

Conditions

None listed

Interventions

Intervention1: HFNC 20 lpm group: HFNC will be applied to the participant at a constant flow of 20 LPM and serial blood gasses will be sampled from a pre-inserted radial catheter at 20 minutes after e

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy men and women aged between 20-50 years 2. Willing to give written, informed consent 3. Willing to comply with protocol requirements 4. Normal physical & systemic examination 5. Have normal hemogram and renal function test in the past 6 months 6. BMI 18 to 30 7. Non-smokers and no history of respiratory disease

Exclusion criteria

Exclusion criteria: 1.Elderly, above 50 years 2.Known respiratory disease 3.Recent less than 3 months mechanical ventilation ICU, hospital admission 4.Anemia 5.History of Hemoglobinopathy, sickle cell disease, thalassemia 6 Positive pregnancy test, females 7.Significant cardiac or pulmonary disease 8.History of sleep apnea 9.Tobacco, drug or alcohol abuse 10.Difficult airway 11.Abnormal ekg, pulmonary function test, room air saturation 12.Intolerance to HFNC apparatus 13.Participation in Phase I study in previous 6 months or in Phase 2 or 3 studies in previous 3 months

Design outcomes

Primary

Measure	Time frame
1. Agreement between measured and predicted arterial partial pressure of oxygen PaO2 for each FiO2 percentage changeTimepoint: At Baseline and after 20 minutes for all 4 sessions intervention sessions mentioned in study protocol	—

Secondary

Measure	Time frame
Change in vital parameters (HR, BP, SpO2, RR) at the end of each session from baseline Timepoint: every 5 minutes from start of intervention till 1 hour after the end of intervention.;Proportion of patients experiencing adverse and serious adverse events.Timepoint: every 5 minutes from start of intervention till 1 hour after the end of intervention.	—

Countries

India

Contacts

Public ContactDr Shiv Lal Soni

Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh

dr.shivsoni@gmail.com9914208550

Outcome results