A proof of concept clinical study to assess the efficacy and safety of VENTIPEEP in stabilizing the Oxygen levels in patients with ARDS
- Conditions
- Health Condition 1: J80- Acute respiratory distress syndrome
- Registration Number
- CTRI/2021/03/032184
- Lead Sponsor
- Flextool equipment pvtltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
1.Written signed and dated informed consent (patient or LAR).
2.Both genders, aged >=18 to <=65 years,
3.Patients with ARDS including COVID-19 patients
4.SpO2>=90% for adults and respiratory rate <= 30/minute
5.Patient in the opinion of the investigator requires the use of Ventipeep oxygen mask
6.BMI <30 kg/m2
7.Patients who provide a agree to abide by the study requirements
1.Pregnant and lactating women
2.Children <18 yrs. of age; elderly >65 years
3.SpO2 >80 for adults and respiratory rate <20/minute
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method SpO2 improvement at 1 hr., 6 hr. and 24 hours after start of ventilation. <br/ ><br>Number of patients achieving 90 % oxygen level in two treatment arms at day 7 and day 14. <br/ ><br>Timepoint: 1 hr., 6 hr. and 24 hours after start of ventilation. <br/ ><br>Day 7 and Day 14. <br/ ><br>
- Secondary Outcome Measures
Name Time Method Total VENTIPEEPTM mask therapy time day 7 and day 14 <br/ ><br>Length of the mask interruptions at day 7 and day 14 <br/ ><br>Cause of the mask interruptions at day 7 and day 14 <br/ ><br>Number of patients requiring intubations at day 7 and day 14. <br/ ><br>Timepoint: DAY 7 & DAY 14