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IRCT20230808059080N1 IRCT 2023-08-14 Babol University of Medical Sciences Assessment of the function of the telemedicine device Assessment of the function of the telemedicine device in order to report lead 2 of electrocardiogram, heart rate, body temperature, peripheral pulse rate and the level of blood oxygen 2023-08-12 anticipated 80 Complete https://irct.ir/trial/71907 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic. 3 Condition 1: Atrial fibrillation and atrial flutter (AF). Condition 2: Ventricular tachycardia (VT). Condition 3: Paroxysmal supraventricular tachycardia (PSVT). Condition 4: Premature ventricular contractions (PVC). Condition 5: Premature atrial contractions (PAC). Condition 6: Atrial tachycardia (AT). Intervention 1: Intervention group: The patients who have at least one of the 6 types of common cardiac arrhythmias diagnosed by the cardiologist and the telemedicine device manufactured in Behbood Samane Hooshmand Teb Company affiliated to Technology Incubator of Babol University of Medical Sciences is installed on their body. This device consists of three chest leads, a thermometer in the armpit and a wireless pulse oximeter that is placed on the participant's finger. Intervention 2: Control group: The adults who do not have any of the 6 types of common cardiac arrhythmias and the telemedicine device manufactured in Behbood Samane Hooshmand Teb Company is installed on their body. This device consists of three chest leads, a thermometer in the armpit and a wireless pulse oximeter that is placed on the participant's finger. Yes - There is a plan to make this available What will be shared: Data of this study can be shared after de-identifying the individuals. When: The access period starts 3 months after the results are published. To whom: Data related to this study will be available both to researchers working in academic and scientific centers and to people working in industry. Conditions: After sending the request email to the corresponding author, data related to this study will be available both to researchers working in academic and scientific centers and to people working in industry. Where to obtain: The corresponding author with email address mt.hedayati@mubabol.ac.ir How to obtain: The data related to this study will be available in time up to two months after sending the request email to the corresponding author. Comments:
public Fazel Tarkhan
Babol University of Medical Sciences, Ganjafrooz Avenue, Babol
Babol Iran (Islamic Republic of) 4717647754 +98 11 3219 7667 medslums@gmail.com Babol University of Medical Sciences scientific Fazel Tarkhan
Babol University of Medical Sciences, Ganjafrooz Avenue, Babol
Babol Iran (Islamic Republic of) 4717647754 +98 11 3219 7667 medslums@gmail.com Babol University of Medical Sciences Iran (Islamic Republic of) Age 18 years and over Refer to the cardiology clinic for check-up or cardiological treatment 18 years no limit Both The patient´s inability to use the telemedicine device Not to provide consent to participate in the study by the patient I48.9 I47.2 I47.1 I49.3 I49.1 I47.1 Unspecified atrial fibrillation and atrial flutter Ventricular tachycardia Supraventricular tachycardia (paroxysmal) Ventricular premature depolarization Atrial premature depolarization Supraventricular tachycardia Diagnosis Diagnosis Intervention group: The patients who have at least one of the 6 types of common cardiac arrhythmias diagnosed by the cardiologist and the telemedicine device manufactured in Behbood Samane Hooshmand Teb Company affiliated to Technology Incubator of Babol University of Medical Sciences is installed on their body. This device consists of three chest leads, a thermometer in the armpit and a wireless pulse oximeter that is placed on the participant's finger. Control group: The adults who do not have any of the 6 types of common cardiac arrhythmias and the telemedicine device manufactured in Behbood Samane Hooshmand Teb Company is installed on their body. This device consists of three chest leads, a thermometer in the armpit and a wireless pulse oximeter that is placed on the participant's finger. Lead 2 of the electrocardiogram. Timepoint: Minute 1, minute 6 and minute 11. Method of measurement: Patient lying supine on a medical bed, after 15 minutes of rest, the medical care device (including three chest leads, an axillary thermometer and a wireless finger pulse oximeter) is installed on his body. The participant will rest again for 5 minutes and then the research primary variables will be measured. Data recording will be initiated at minute 1. With 5-minute intervals, three times of measurement will be carried out on each patient using three SEMS-HIOT devices produced by the Behbood Samane Hooshmand Teb Company affiliated to Technology Incubator of Babol University of Medical Sciences, and one time measurement with a standard device. Body temperature. Timepoint: Minute 1, minute 6 and minute 11. Method of measurement: Patient lying supine on a medical bed, after 15 minutes of rest, the medical care device (including three chest leads, an axillary thermometer and a wireless finger pulse oximeter) is installed on his body. The participant will rest again for 5 minutes and then the research primary variables will be measured. Data recording will be initiated at minute 1. With 5-minute intervals, three times of measurement will be carried out on each patient using three SEMS-HIOT devices produced by the Behbood Samane Hooshmand Teb Company affiliated to Technology Incubator of Babol University of Medical Sciences, and one time measurement with a standard device. The level of blood oxygen. Timepoint: Minute 1, minute 6 and minute 11. Method of measurement: Patient lying supine on a medical bed, after 15 minutes of rest, the medical care device (including three chest leads, an axillary thermometer and a wireless finger pulse oximeter) is installed on his body. The participant will rest again for 5 minutes and then the research primary variables will be measured. Data recording will be initiated at minute 1. With 5-minute intervals, three times of measurement will be carried out on each patient using three SEMS-HIOT devices produced by the Behbood Samane Hooshmand Teb Company affiliated to Technology Incubator of Babol University of Medical Sciences, and one time measurement with a standard device. Peripheral pulse rate. Timepoint: Minute 1, minute 6 and minute 11. Method of measurement: Patient lying supine on a medical bed, after 15 minutes of rest, the medical care device (including three chest leads, an axillary thermometer and a wireless finger pulse oximeter) is installed on his body. The participant will rest again for 5 minutes and then the research primary variables will be measured. Data recording will be initiated at minute 1. With 5-minute intervals, three times of measurement will be carried out on each patient using three SEMS-HIOT devices produced by the Behbood Samane Hooshmand Teb Company affiliated to Technology Incubator of Babol University of Medical Sciences, and one time measurement with a standard device. Heart rate. Timepoint: Minute 1, minute 6 and minute 11. Method of measurement: Patient lying supine on a medical bed, after 15 minutes of rest, the medical care device (including three chest leads, an axillary thermometer and a wireless finger pulse oximeter) is installed on his body. The participant will rest again for 5 minutes and then the research primary variables will be measured. Data recording will be initiated at minute 1. With 5-minute intervals, three times of measurement will be carried out on each patient using three SEMS-HIOT devices produced by the Behbood Samane Hooshmand Teb Company affiliated to Technology Incubator of Babol University of Medical Sciences, and one time measurement with a standard device. Acceptance of the device by the patient. Timepoint: At the end of the intervention. Method of measurement: By asking a question about the patient's satisfaction with the device. Babol University of Medical Sciences Approved 2023-03-06 Ethics Committee of Babol University of Medical Sciences Babol University of Medical Sciences, Ganjafrooz Avenue, Babol Babol Mazandaran Iran (Islamic Republic of)