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IRCT20130311012782N26 IRCT 2019-02-26 Esfahan University of Medical Sciences The effect of Non-invasive ventilation (NIV) on the body composition and Body Mass Index (BMI) in the patients with obesity hypoventilation (OHS) The effect of Non-invasive ventilation (NIV) on the body composition and Body Mass Index (BMI) in the patients with obesity hypoventilation (OHS) 2019-04-21 anticipated 33 Complete https://irct.ir/trial/37557 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 3 Extreme obesity with alveolar hypoventilation. Intervention group: Patients who first time use BIPAP. The patients will use BIPAP device during sleep. The BIPAP device that will be used is RESMED lumis 100 (produced by RESMED company San Diego, California, US). Yes - There is a plan to make this available What will be shared: whole data will be available. When: Immediately after publishing the manuscript of research To whom: All person who need this data Conditions: All person who need this data Where to obtain: Dr Amra, University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran How to obtain: Sending an email to Amrababak@gmail.com. Data will send shortest possible time Comments:
public Dr. Babak Amra
Isfahan Medical University, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 81746-73461 +98 913 313 9294 Amrababak@gmail.com Esfahan University of Medical Sciences scientific Dr. Babak Amra
Esfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran
Esfahan Iran (Islamic Republic of) 81746-73461 +98 913 313 9294 Amrababak@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) BMI upper than 30 Arterial carbon dioxide upper than 45 Using BIPAP device for the first time no limit no limit Both Asthma Obstructive Pulmonary Disease Heart Failure Pregnancy Using weight loss drugs Using Corticosteroids Drugs E66.2 Morbid (severe) obesity with alveolar hypoventilation Treatment - Devices Intervention group: Patients who first time use BIPAP. The patients will use BIPAP device during sleep. The BIPAP device that will be used is RESMED lumis 100 (produced by RESMED company San Diego, California, US) Body water of patient. Timepoint: Begin of studying then one week, one month and six months. Method of measurement: With the help of Bioimpedance analyzer. Body protein of patient. Timepoint: Begin of studying then one week, one month and six months. Method of measurement: With the help of Bioimpedance analyzer. Body fat of patient. Timepoint: Begin of studying then one week, one month and six months. Method of measurement: With the help of Bioimpedance analyzer. Blood PCO2 of patient. Timepoint: Begin of studying then one week, one month and six months. Method of measurement: Capnography. Body Mass Index (BMI). Timepoint: Begin of studying then one week, one month and six months. Method of measurement: Using the balance, the weight of the patient will be measure and by using meter the height of patient will be measure. O2 saturation. Timepoint: Begin of studying then one week, one month and six months. Method of measurement: Pulse Oximetery. Esfahan University of Medical Sciences Approved 2017-05-17 Ethics committee of Isfahan University of Medical Sciences Isfahan University of Medical sciences, Hezar Jareeb street,Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)