PDF of Trial CTRI Website URL - http://ctri.nic.in

Clinical Trial Details (PDF Generation Date :- Mon, 27 Sep 2021 10:10:10 GMT)

CTRI Number CTRI/2021/02/031545 [Registered on: 25/02/2021] - Trial Registered Prospectively Last Modified On 24/02/2021 Post Graduate Thesis No Type of Trial Observational Type of Study Cross Sectional Study Study Design Single Arm Trial Public Title of Study This is a comparison study between perceived comfort, acceptability and efficiency between low cost loose fitting PAPR and PPE ( full body PPE, along with N95 mask, goggles, and also a face shield in the front) Scientific Title of Usability study on the Powered Air Purifying Respirator (PAPR) with AIMS medical staff Study Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Ayyappan A Trial Coordinator (multi-center study) Designation Embedded Systems Engineer Affiliation AMMACHI Labs Address AMMACHI Labs(Amrita Multi Modal Applications and Human Computer Interaction), Amrita Vishwa Vidyapeetham ,Amritapuri, Clappana, , , 690525, KERALA 690525 India Phone 9188370785 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Ayyappan A Query) Designation Embedded Systems Engineer Affiliation AMMACHI Labs Address AMMACHI Labs (Amrita Multi Modal Applications and Human Computer Interaction), Amrita Vishwa Vidyapeetham ,Amritapuri, Clappana, OACHIRA, KERALA, 690525, India Kollam KERALA 690525 India Phone 9188370785 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Ayyappan A Designation Embedded Systems Engineer Affiliation AMMACHI Labs Address AMMACHI Labs (Amrita Multi Modal Applications and Human Computer Interaction), Amrita Vishwa Vidyapeetham ,Amritapuri, Clappana, OACHIRA, KERALA, 690525, India Kollam

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KERALA 690525 India Phone 9188370785 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Ammachilabs, Amrita Vishwa Vidyapeetham ,Amritapuri, Clappana, OACHIRA, KERALA, 690525, India Primary Sponsor Primary Sponsor Details Name Amrita Vishwa Vidyapeetham Address Amrita Vishwa Vidyapeetham, Amritapuri, Clappana, OACHIRA, KERALA, 690525, India Type of Sponsor Other [Seed funding ] Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Sundeep AIMS (Amrita hospital) Two adult Non-COVID 9447082020 Vijayaraghavan wards, Ponekkara P.O, , Kerala 682041, [email protected] India .edu Ernakulam KERALA Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Institutional Ethics Approved 02/02/2021 No committee, Amrita Institute of medical sciences Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Healthy Human Volunteers Nurses/doctors Intervention / Type Name Details Comparator Agent Intervention Nil Nil Comparator Agent Nil Nil Inclusion Criteria Inclusion Criteria Age From 20.00 Year(s) Age To 60.00 Year(s) Gender Both Details Full time health worker (Nurse/ doctor) Exclusion Criteria Exclusion Criteria Details Other than nurses/doctors Method of Generating Not Applicable Random Sequence Method of Not Applicable

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Concealment Blinding/Masking Not Applicable Primary Outcome Outcome Timepoints Differences in perceived comfort, acceptability Task assigned for 3 hours per day for the and efficiency between Low cost loose fitting nurse/doctor while wearing PAPR/PPE PAPR and PPE ( full body PPE, along with N95 mask, goggles, and also a face shield in the front) Secondary Outcome Outcome Timepoints Vitals data of the staffs. Before and after the task completion Target Sample Size Total Sample Size=20 Sample Size from India=20 Final Enrollment numbers achieved (Total)=Applicable only for Completed/Terminated trials Final Enrollment numbers achieved (India)=Applicable only for Completed/Terminated trials Phase of Trial N/A Date of First 01/03/2021 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=0 Trial Months=2 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Not Yet Recruiting Trial (India) Publication Details Nil Brief Summary The coronavirus pandemic has affected millions of lives around the world. The availability of personal protective equipment at a low cost and its rational use and reuse has been a critical factor in determining the well-being of frontline health workers who have been integral to the global response to COVID-19. We have designed and developed a low-cost powered air-purifying respirator (PAPR) for medical professionals which costs less than INR 30,000. The PAPR delivers an airflow of 11 CFM or higher, static pressure of 1.6 in H2O, noise levels of less than 68 dB, and a battery life of over 10 hours. We have currently made 20 pieces of this PAPR design for doctors at AIMS to be used and tested in In Non-Wards COVID at the initial stages. Primary objective of study is to is to identify the differences in perceived comfort, acceptability and efficiency between Low cost loose fitting PAPR and PPE ( full body PPE, along with N95 mask, goggles, and also a face shield in the front).

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