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IRCT20140109016151N10 IRCT 2021-11-27 Iran University of Medical Sciences Effect of using Covid۱۹ intubation box on success rate and time of tracheal intubation in patients undergoing surgery under general anesthesia Effect of using Covid۱۹ intubation box on success rate and time of tracheal intubation in patients undergoing surgery under general anesthesia 2021-12-21 anticipated 100 Complete https://irct.ir/trial/60209 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, we use the block randomization method. to randomize the two treatment methods, we create 4 blocks in six different states, then select a number using the table of numbers, and determine the study groups by matching the numbers with the blocks. For example, if the first digit of our number is 1 to 6, select a block and the division is done, but if, for example, our number is 94071, the digit 9 is not valid and we select the next digit. Here, based on the block, we divide 4 people into groups. 1. TTCC 2. TCTC 3. TCCT 4. CCTT 5. CTCT 6. CTTC, Blinding description: In this study, people who are responsible for patient care and analysis of statistical data do not know about the treatment process and study groups, and information is provided to them in groups A and B. 3 General surgery. Intervention 1: Intervention group: Intervention group: After obtaining informed consent, patients are randomly selected into two groups. In the first group, preoperative clinical examinations are performed. For patients, complete monitoring is performed and fluid therapy is performed, then anesthesia drugs to initiate anesthesia and airway intubation are injected as follows: midazolam 0.02 mg by weight, fentanyl 3 micrograms by weight, propofol 2 Mg by weight and atracurium 0.5 mg by weight.Then, for the patients in the intervention group, Covid 19 Box intubation consists of a clear, cubic-shaped clear acrylic chamber with two inlets for the anesthesiologist to insert into the airway. airway intubation is then performed and the time it takes for the endotracheal tube to enter the mouth to enter the glottis is recorded and measured. Success in airway intubation is also recorded. Intervention 2: Control group: Control group: After obtaining informed consent, patients are randomly selected into two groups. In the control group, preoperative clinical examinations are performed. For patients, complete monitoring is performed and fluid therapy is performed, then anesthesia drugs to initiate anesthesia and airway intubation are injected as follows: midazolam 0.02 mg by weight, fentanyl 3 micrograms by weight, propofol 2 Mg by weight and atracurium 0.5 mg by weight. Then, for the patients in the control group, airway intubation is performed normally using a laryngoscope and Macintosh blade No. 4. Then airway intubation is performed and the time of endotracheal tube entry into the mouth to enter the glottis is recorded and measured. Be. Success rates for airway intubation are also recorded. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Alireza Pournajafian
Anesthesia Department, Firouzgar Hospital ,Beh-afarin street
Tehran Iran (Islamic Republic of) 8874113911 +98 21 8894 6762 a-pournajafian@tums.ac.ir Iran University of Medical Sciences scientific Alireza Pournajafian
Anesthesia Department, Firouzgar Hospital ,Beh-afarin street
Tehran Iran (Islamic Republic of) 8874113911 +98 21 8894 6762 a-pournajafian@tums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Patient with ASA 1 , 2 Patient with Malampati scale 1 , 2 Patients aged between 20 and 60 years 20 years 60 years Both Failure to airway intubation after two attempts with Covid۱۹ intubation box Defective airway intubation tools Y81.1 Therapeutic (nonsurgical) and rehabilitative general- and plastic-surgery devices associated with adverse incidents Treatment - Devices Treatment - Devices Intervention group: Intervention group: After obtaining informed consent, patients are randomly selected into two groups. In the first group, preoperative clinical examinations are performed. For patients, complete monitoring is performed and fluid therapy is performed, then anesthesia drugs to initiate anesthesia and airway intubation are injected as follows: midazolam 0.02 mg by weight, fentanyl 3 micrograms by weight, propofol 2 Mg by weight and atracurium 0.5 mg by weight.Then, for the patients in the intervention group, Covid 19 Box intubation consists of a clear, cubic-shaped clear acrylic chamber with two inlets for the anesthesiologist to insert into the airway. airway intubation is then performed and the time it takes for the endotracheal tube to enter the mouth to enter the glottis is recorded and measured. Success in airway intubation is also recorded. Control group: Control group: After obtaining informed consent, patients are randomly selected into two groups. In the control group, preoperative clinical examinations are performed. For patients, complete monitoring is performed and fluid therapy is performed, then anesthesia drugs to initiate anesthesia and airway intubation are injected as follows: midazolam 0.02 mg by weight, fentanyl 3 micrograms by weight, propofol 2 Mg by weight and atracurium 0.5 mg by weight. Then, for the patients in the control group, airway intubation is performed normally using a laryngoscope and Macintosh blade No. 4. Then airway intubation is performed and the time of endotracheal tube entry into the mouth to enter the glottis is recorded and measured. Be. Success rates for airway intubation are also recorded. Airway intubation time. Timepoint: Beginning of induction of anesthesia. Method of measurement: The watch. Success rate of airway intubation. Timepoint: Beginning of induction of anesthesia. Method of measurement: Observation. Iran University of Medical Sciences Approved 2021-03-02 Ethics committee of Iran University of Medical Sciences Tehran, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)