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IRCT20210216050379N3 IRCT 2022-05-15 Shahid Beheshti University of Medical Sciences The effect of New oxygenation device on respiratory function enhancment. The prevention effect of new oxygenation device versus nasal cannula in increasing exhalation co2 2022-05-10 anticipated 200 Complete https://irct.ir/trial/63114 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: The device was tested by studying cataract patients and had significant results and was accepted at the World Anesthesia Congress in Prague, Randomization description: 200 patients scheduled for blepharoplasty surgery by simple randomization located in two groups:nasal canulla and new oxygenation device .the method of randomization and concealment was as follows:we started from the number1 to 200 and assigned the odd numbers to the nasal canulla group and the even numbers to the new ventilation device, Blinding description: The researcher and the person conducting the measurement and data collection do not know the patient grouping. N/A The preventive effect of new oxygenation device versus nasal canulla in increasing exhalation Co2. Intervention 1: Intervention group: Patients in intervention group (A) receive 4 liters per minute of oxygen by a new oxygenation device that is sterile, reusable and washable. The polylactic acid weighs 110 grams and then placed on the patient's chest and with complete cardio-respiratory monitoring (EKG, SPO2, End Tidal co2, BP, RR) the patient's hemodynamic status and with the Richmond questionnaire, sedation status of The onset of the operation is measured and recorded up to 10 minutes after the operation, then the results are given to a statistician to analyze the data are obtained. P-value less than 0.05 will be considered significant. Intervention 2: Control group: Patients in this group (B) are traditionally treated using a disposable nasal cannula made by Supao Company with a flow of 4 liters per minute of oxygen.Capnotrack is attached to the nasal cannula and exhaled carbon dioxide is transferred to the capnograph, and as intervention group, complete cardio respiratory monitoring is performed. Yes - There is a plan to make this available What will be shared: Individual data is shared after it is unidentifiable and the main outcome When: From May 1402 onwards To whom: Professors and Medical students Conditions: For more research Where to obtain: Contact Hamidreza Azizifarsani by email How to obtain: up to 10 days after the call Comments:
public Hamidreza Azizifarsani
NO.1,Shahid lamee st,faraze jonobi,koye faraz,saadatabad,Tehran
Tehran Iran (Islamic Republic of) 1981956316 +98 21 2238 2080 h.faresani@gmail.com Shahid Beheshti University of Medical Sciences scientific Hamidreza Azizifarsani
No 1, Shahid lamee st, faraze jonobi, koye faraz, saadat abad,Tehran
Tehran Iran (Islamic Republic of) 1981956316 +98 21 2238 2080 h.faresan@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Local blepharoplasty surgery via intravenous sedation 30 years 70 years Both Chronic pulmonary, cardiovascular, renal, hepatic dysfunction or psychiatric disorders. Sever chest wall deformity. Patients without the possibility of cooperation such as language problems or deafness. موضوع ما بیماری نیست Prevention Prevention Intervention group: Patients in intervention group (A) receive 4 liters per minute of oxygen by a new oxygenation device that is sterile, reusable and washable. The polylactic acid weighs 110 grams and then placed on the patient's chest and with complete cardio-respiratory monitoring (EKG, SPO2, End Tidal co2, BP, RR) the patient's hemodynamic status and with the Richmond questionnaire, sedation status of The onset of the operation is measured and recorded up to 10 minutes after the operation, then the results are given to a statistician to analyze the data are obtained. P-value less than 0.05 will be considered significant. Control group: Patients in this group (B) are traditionally treated using a disposable nasal cannula made by Supao Company with a flow of 4 liters per minute of oxygen.Capnotrack is attached to the nasal cannula and exhaled carbon dioxide is transferred to the capnograph, and as intervention group, complete cardio respiratory monitoring is performed. Measurement of End tidal co2 and peripheral oxygen saturation. Timepoint: IN 0, 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 70, 80, 90 minutes. Method of measurement: Capnography and Pulse oximetery device. Respiratory Rate. Timepoint: In 0, 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 70, 80 and 90 minutes. Method of measurement: Inspection ,counting the number of inhales and exhales in the mentioned minutes. Blood pressure. Timepoint: In 0, 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 70, 80, 90 minutes. Method of measurement: Sphygmomanometer (non invasive). Agitation and restlessness. Timepoint: In 0, 5, 10,15, 20, 25, 30, 35, 40, 50, 60, 70, 80, 90 minutes. Method of measurement: Richmond Agitation -sedation Questionnaire. Shahid Beheshti University of Medical Sciences Approved 2022-01-10 Ethics committee of shahid beheshti university of medical science Medical school, Shahid Beheshti University of Medical Sciences, Arabi Ave, Daneshjoo Blvd, Velengak, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)