Post Market Clinical Follow Up of SkanRespiro Plus and Pranaa
Phase 4
Completed
- Conditions
- Health Condition 1: J069- Acute upper respiratory infection,unspecifiedHealth Condition 2: J953- Chronic pulmonary insufficiency following surgeryHealth Condition 3: J709- Respiratory conditions due to unspecified external agentHealth Condition 4: J969- Respiratory failure, unspecifiedHealth Condition 5: J689- Unspecified respiratory conditiondue to chemicals, gases, fumes and vapors
- Registration Number
- CTRI/2022/05/042810
- Lead Sponsor
- Skanray Technologies Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Adult and pediatric subjects of age more than two year or body weight of 10 kg above whichever is lower and of either gender.
Subjects who need mechanical ventilation.
Subject or the legally authorised representative on behalf of subject shall be capable of understanding and signing the informed consent form.
Exclusion Criteria
Subjects with age less than two year or less than 10 kg of body weight.
Subjects who need ventilation during transport.
Pregnant or nursing mother.
Unconscious subjects shall be excluded from the non invasive mode of ventilation.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Determining the performance in terms of delivered parameters against the intended or set values for the specific subject condition.Timepoint: Every 4 hours
- Secondary Outcome Measures
Name Time Method Collection of feedback which includes investigator’s assessment of the overall safety and performance of the SkanRespiro Plus and Pranaa. <br/ ><br> <br/ ><br>Collection of feedback from the user reflecting the ease of ventilation and usability. <br/ ><br> <br/ ><br>The collection of evidence reflecting the subject ventilation <br/ ><br>Timepoint: Every seventh day or earlier