Health Condition 1: J80- Acute respiratory distress syndrome
Conditions
Interventions
Intervention1: VentiPEEP: VENTIPEEP is a mask similar to CPAP mask. The mask contains a Venturi Flow Driver to provide a constant flow rate with a desired FiO2. The mask also comprises a PEEP valve to
Sponsors
Flextool equipment pvtltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Written signed and dated informed consent (patient or LAR). 2. Both genders, aged >=18 to 3. Patients with ARDS including COVID-19 patients 4. SpO2>=90% for adults and respiratory rate 5. Patient in the opinion of the investigator requires the use of Ventipeep oxygen mask 6. BMI 7. Patients who provide a agree to abide by the study requirements
Exclusion criteria
Exclusion criteria: 1. Pregnant and lactating women 2. Children 65 years 3. SpO2 >80 for adults and respiratory rate 4. Patients having known tendency to nausea/vomiting or pharyngeal pathology 5. Planned Tracheal intubation 6. Patients known to have Gastro-Esophageal Reflux Disease (GERD), hiatus hernia or previous upper gastrointestinal tract surgery 7. Need for direct admission to the intensive care unit for mechanical ventilation 8. Underlying chronic obstructive pulmonary disease stage III-IV 9. Patients simultaneously participating in another clinical study. 10. Speech or swallowing impairment (risk of aspiration) 11. History of stroke with significant neurologic deficit. 12. Recent heart or lung surgery within 3 months 13. Medical or psychological conditions deemed by the investigators to interfere with successful participation in the study 14. A subject who is judged by the investigator as inappropriate to participate in the study for any reason other than those mentioned above.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SpO2 improvement at 1 hr., 6 hr. and 24 hours after start of ventilation. Number of patients achieving 90 % oxygen level in two treatment arms at day 7 and day 14. Timepoint: 1 hr., 6 hr. and 24 hours after start of ventilation. Day 7 and Day 14. | — |
Secondary
| Measure | Time frame |
|---|---|
| Total VENTIPEEPTM mask therapy time day 7 and day 14 Length of the mask interruptions at day 7 and day 14 Cause of the mask interruptions at day 7 and day 14 Number of patients requiring intubations at day 7 and day 14. Timepoint: DAY 7 & DAY 14 | — |
Countries
India
Contacts
Public ContactDisha Shetty
Samahitha Research Solutions
Outcome results
None listed