CTRI Trial Data

PDF of Trial CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Mon, 27 Sep 2021 13:31:10 GMT) CTRI Number CTRI/2021/03/031666 [Registered on: 02/03/2021] - Trial Registered Prospectively Last Modified On 01/04/2021 Post Graduate Thesis No Type of Trial Observational Type of Study Case Control Study Study Design Non-randomized, Multiple Arm Trial Public Title of Study Post-operative complications and mortality in patients with COVID 19 undergoing surgery under anaesthesia- A single centre retrospective case control study Scientific Title of Post-operative morbidity and mortality in patients with RT-PCR confirmed COVID19 undergoing Study surgery under regional or general anaesthesia- A single centre retrospective case control study. Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Dr Saloni Paranjape Trial Coordinator (multi-center study) Designation Consultant Affiliation BLK Superspeciality Hospital Address Dept of Anaesthesia, Second floor- OT complex, BLK superspeciality hospital, Pusa Road, Rajendra Place, New Delhi. Pusa Road, Rajendra place, New Delhi Central DELHI 110005 India Phone 9958074656 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Saloni Paranjape Query) Designation Consultant Affiliation BLK Superspeciality Hospital Address BLK Superspeciality Hospital, second floor- OT complex. Pusa Road, Rajendra place, New Delhi Pusa Road, Rajendra place, New Delhi Central DELHI 110005 India Phone 9958074656 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr Saloni Paranjape Designation Consultant Affiliation BLK Superspeciality Hospital Address Dept Of Anaesthesia, second floor- OT complex, Pusa Road, Rajendra place, New Delhi Pusa Road, Rajendra place, New Delhi Central DELHI 110005 page 1 / 3 PDF of Trial CTRI Website URL - http://ctri.nic.in India Phone 9958074656 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > BLK Superspeciality hospital. Pusa Road, Rajendra Place. New Delhi 110008 Primary Sponsor Primary Sponsor Details Name Dr Saloni Paranjape Address Second floor, 7/49 South Patel Nagar, New Delhi Type of Sponsor Other [Individual ] 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 Saloni Paranjape BLK Superspeciality Dept of Anaesthesia, 9958074656 Hospital Second Floor OT complex,Rajendra [email protected] place, Pusa Road, New Delhi-110005 Central DELHI Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? B.L.Kapur Memorial Approved 29/01/2021 No Hospital Ethics Committee Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Coronavirus as the cause of diseases classified elsewhere Intervention / Type Name Details Comparator Agent Comparator Agent No intervention Patients with COVID RTPCR positive undergoing emergency surgery will be compared with age and sex matched COVID RTPCR negative patients undergoing emergency surgery Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 99.00 Year(s) Gender Both Details All COVID RTPCR positive patients undergoing surgery under general or regional anaesthesia Exclusion Criteria Exclusion Criteria Details 1) Patients testing negative for COVID RTPCR prior to surgery 2) Patients testing positive for COVID RTPCR after surgery but were negative before surgery page 2 / 3 PDF of Trial CTRI Website URL - http://ctri.nic.in 3) Patients undergoing cardiac or neurosurgery Method of Generating Not Applicable Random Sequence Method of Not Applicable Concealment Blinding/Masking Not Applicable Primary Outcome Outcome Timepoints To identify the outcomes of COVID 19 positive 1) at discharge from hospital patients undergoing surgery in terms of post 2) 30 day mortality (from date of surgery) operative complications and mortality Secondary Outcome Outcome Timepoints Identify risk factors for morbidity and mortality in At hospital discharge COVID 19 positive patients Target Sample Size Total Sample Size=30 Sample Size from India=30 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 15/03/2021 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=0 Trial Months=6 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Open to Recruitment Trial (India) Publication Details NA Brief Summary This study is a single centre retrospective case control study on the post operative morbidity and mortality in RTPCR confirmed COVID-19 patients undergoing surgery under regional or general anaesthesia. We plan to undertake a retrospective analysis of data of all COVID 19 RTPCR positive patients who underwent surgery at our hospital from April 2020 to December 2020. Our primary aim is to identify the outcomes of COVID 19 patients undergoing surgery in terms of ventilator days, ICU stay, hospital stay, postoperative complications and in hospital and 30 day mortality. Our secondary aim is to identify risk factors for higher morbidity and mortality. Controls will be matched for age, sex and type of surgery. page 3 / 3 Powered by TCPDF (www.tcpdf.org).

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