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

Clinical Trial Details (PDF Generation Date :- Tue, 28 Sep 2021 19:32:30 GMT)

CTRI Number CTRI/2015/11/006336 [Registered on: 02/11/2015] - Trial Registered Retrospectively Last Modified On 16/11/2019 Post Graduate Thesis Yes Type of Trial Interventional Type of Study Physiotherapy (Not Including YOGA) Study Design Other Public Title of Study COMPARISION OF FLOW AND VOLUME ORIENTED INCENTIVE SPIROMETRY IN PATIENTS UNDERGOING OPEN ABDOMINAL SURGERY Scientific Title of COMPARISION OF FLOW AND VOLUME ORIENTED INCENTIVE SPIROMETRY ON Study PULMONARY FUNCTION AND EXERCISE TOLERANCE IN PATIENTS UNDERGOING OPEN ABDOMINAL SURGERY - A RANDOMIZED CLINICAL TRIAL. Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name A GOPALA KRISHNA Trial Coordinator (multi-center study) Designation ASSISTANT PROFESSOR Affiliation KASTURBA MEDICAL COLLEGE Address Department of Physiotherapy KMC, Light House Hill road, Hampankatta, Mangalore Dakshina KARNATAKA 575001 Department of Physiotherapy KMC, Mangalore Light House Hill road, Hampankatta, Mangalore Karnataka KARNATAKA 575001 Dakshina Kannada KARNATAKA 575001 Phone 9916819977 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name ASAMPATH KUMAR Query) Designation Affiliation KASTURBA MEDICAL COLLEGE Address Department of Physiotherapy KMC, Mangalore Light House Hill road, Hampankatta, Mangalore Karnataka Dakshina Kannada KARNATAKA 575001 Department of Physiotherapy KMC, Mangalore Light House Hill road, Hampankatta, Mangalore Karnataka Dakshina Kannada KARNATAKA 575001 Dakshina Kannada KARNATAKA 575001 India Phone 8105819191 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name A GOPALA KRISHNA Designation ASSISTANT PROFESSOR Affiliation KASTURBA MEDICAL COLLEGE

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Address Department of Physiotherapy KMC, Mangalore Light House Hill road, Hampankatta, Mangalore Karnataka Dakshina Kannada KARNATAKA 575001 Department of Physiotherapy KMC, Mangalore Light House Hill road, Hampankatta, Mangalore Karnataka Dakshina Kannada KARNATAKA 575001 Dakshina Kannada KARNATAKA 575001 India Phone 9916819977 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > MANIPAL UNIVERSITY Primary Sponsor Primary Sponsor Details Name KASTURBA MEDICAL COLLEGE Address LIGHT HOUSE HILL ROAD, MANGALORE, MANIPAL UNIVERSITY Type of Sponsor Private medical college 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 SAMPATH KUMAR KMC Hospitals, 2nd floor, Dept of physi 8105819191 AMARAWADI Mangalore otherapy,Ambedkar circle. OPD-3, 2nd floor, [email protected] Dept of m physiotherapy,Attavar. Dakshina Kannada KARNATAKA Dakshina Kannada KARNATAKA Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? INSTTUTIONAL Approved 13/11/2013 No ETHICS COMMITTEE Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Disorders of esophagus in diseasesclassified elsewhere Patients PATIENTS UNDERGOING ABDOMINAL SURGERY Intervention / Type Name Details Comparator Agent Intervention FLOW ORIENTED INCENTIVE The Flow oriented Incentive SPIROMETER spirometer device will have the marker reaching the appropriate level with a quick or sustained deep breath so long as a sufficient flow is achieved (Triflo device).

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Comparator Agent VOLUME ORIENTED Volume oriented Incentive INCENTIVE SPIROMETER spirometer devices have a visible scale measuring Inspiratory capacity on which the patient lifts a marker as high as possible. Devices known as volume accumulators have markers for volume and flow (coach 2 device). Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 90.00 Year(s) Gender Both Details Patients aged 18 years above who are undergoing any open abdominal surgery referred by the consultant. Exclusion Criteria Exclusion Criteria Details 1. Laparoscopic surgery. 2. Gynecological surgeries like Hysterectomy and lower section caesarean section. 3. Unstable hemodynamic parameters. 4. Post operative complications requiring mechanical ventilation. 5. Uncooperative patient.

Method of Generating Computer generated randomization Random Sequence Method of An Open list of random numbers Concealment Blinding/Masking Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded Primary Outcome Outcome Timepoints PULMONARY FUNCTION TEST Pre-operative & Post-operative Day 1, 2, 3, 4 & 5 Secondary Outcome Outcome Timepoints six minute walk test (6MWT) The exercise tolerance will be measured by six minute walk test (6MWT) taken in the preoperative period in both groups and it will be measured again at the time of discharge. Target Sample Size Total Sample Size=30 Sample Size from India=30 Final Enrollment numbers achieved (Total)= Final Enrollment numbers achieved (India)= Phase of Trial N/A Date of First 17/06/2014 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=0 Trial Months=10 Days=0 Recruitment Status of Completed Trial (Global) Recruitment Status of Completed Trial (India) Publication Details none yet Brief Summary COMPARISION OF FLOW AND VOLUME ORIENTED INCENTIVE SPIROMETRY ON PULMONARY FUNCTION AND EXERCISE TOLERANCE IN PATIENTS UNDERGOING OPEN ABDOMINAL SURGERY - A RANDOMIZED CLINICAL TRIAL.COMPARISION OF FLOW AND VOLUME ORIENTED INCENTIVE SPIROMETRY ON PULMONARY FUNCTION AND EXERCISE TOLERANCE IN PATIENTS UNDERGOING OPEN ABDOMINAL SURGERY - A RANDOMIZED CLINICAL TRIAL.

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The trial is to compare the effects of Flow oriented and Volume–oriented Incentive spirometer on pulmonary function and exercise tolerance in patients undergoing open abdominal surgery.

During trial procedure subjects will be 1st screened for their eligibility on inclusion and exclusion criteria and then they will be allowed to participate in this study. Demographic data will be collected. There after other pre-treatment baseline data such as PFT and 6 minute walk test will be taken.

The patient will be asked to take long, slow, deep breaths with a Incentive spirometer providing patients with visual feedback.

Subjects will be allocated into two groups. Group A will receive flow oriented incentive spiometer, while group B will receive volume oriented incentive spiometer.

Both groups will receive treatment for 4 consecutive days and on the day of discharge. Pulmonary function tests(PFT) will be taken in the preoperative period and it will be measured again 1st,2nd,3rd,4th post-operative day and at the time of discharge in both groups. The 6

minute walk test

will be taken preoperative period in the both groups and at the time of discharge.

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