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IRCT20220511054817N1 IRCT 2022-05-22 Ghoum University of Medical Sciences Comparison of successful endotracheal intubation between the " standard-method " and " Modified-ramped position" Comparison of successful endotracheal intubation between the " standard-method " and " Modified-ramped position" 2022-05-15 anticipated 112 Complete https://irct.ir/trial/63437 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Samples are easily entered into the study and randomly assigned to intervention and control groups. The site https://www.sealedenvelope.com/simple-randomiser/v1/lists will be used for random allocation of samples by randomized block method, Blinding description: Patients who meet the inclusion criteria enter the study after receiving full explanations about the research and how to conduct the research and obtain informed consent.Cases are divided into two groups of case and control by random sampling method.Intubation of both intervention and control groups is performed by an anesthesiologist and the data is collected and completed by an operating room technician who is not aware of the intervention and control group in the research through a checklist prepared by the researcher.Data analysis is performed by a statistical expert who is not aware of the intervention and control group in the research. N/A Intubation of surgical candidate patients. Intervention 1: Intervention group: In the intervention group (M), the patient is placed in a supine position on a modified RAMP (a trapezoidal device with a height of 15 cm, and a length of 80 cm, with an angle of 30 degrees, which has a length of 20 cm and 80 cm). .)At the entrance to the operating room, an airway evaluation is performed for patients (including Malampati score, Cormac Lehan, thyromental distance, mouth opening, and neck extension).Prior to surgery, patients will receive IV isotonic fluid. Before induction of anesthesia, conventional monitors including electrocardiogram, non-invasive blood pressure monitor and pulse oximetry will be used for evaluation. For induction of anesthesia, 1-2 mg / kg propofol, 0.1 mg / kg cis atracurium and 0.2 μg / kg sufentanil are used.Also, ventilation mask using face mask, 3 minutes before induction is done as current volume ventilation, then with tube number 7 - 7.5 - 8 by the same anesthesiologist and using Macintosh laryngoscope intubation is done. The correct position of the endotracheal tube is confirmed by capnography and after intubation, the patient returns to the standard position after 10 minutes with caution.Then, 6 to 12 hours after the operation, the patient's satisfaction is recorded based on the patient's general condition and the feeling of pain after intubation by visual analog scale. Intervention 2: Control group: n the control group (S), patients are usually placed in the supine position and a pillow 10 cm high is placed under the patient's head.At the entrance to the operating room, an airway evaluation is performed for patients (including Malampati score, Cormac Lehan, thyromental distance, mouth opening, and neck extension).Prior to surgery, patients will receive IV isotonic fluid. Before induction of anesthesia, conventional monitors including electrocardiogram, non-invasive blood pressure monitor and pulse oximetry will be used for evaluation. For induction of anesthesia, 1-2 mg / kg propofol, 0.1 mg / kg cis atracurium and 0.2 μg / kg sufentanil are used.Also, ventilation mask using face mask, 3 minutes before induction is done as current volume ventilation, then with tube number 7 - 7.5 - 8 by the same anesthesiologist and using Macintosh laryngoscope intubation is done. The correct position of the endotracheal tube is confirmed by capnography and after intubation, the patient returns to the standard position after 10 minutes with caution.Then, 6 to 12 hours after the operation, the patient's satisfaction is recorded based on the patient's general condition and the feeling of pain after intubation by visual analog scale. 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 Sourena Rezvani dehaghani
No. 20, Valiasr Ave., Aqdasiyeh
Tehran Iran (Islamic Republic of) 1694733415 +98 21 2295 2912 Sourena1374@gmail.com Ghoum University of Medical Sciences scientific Sourena Rezvani Dehaghani
No. 20, Valiasr Ave.,Artesh Blvd., Aqdasiyeh
Tehran Iran (Islamic Republic of) 1694733415 +98 21 2295 2912 Sourena1374@gmail.com Ghoum University of Medical Sciences Iran (Islamic Republic of) Patients aged between 15 and 80 years Patients with Malampati Score 2 to 4 Patients who will undergo non-emergency general anesthesia Having informed consent to participate in the study 15 years 85 years Both Patients undergoing local or spinal anesthesia Patient dissatisfaction at any stage of the research Restriction of position in the modified ramp position History of any disease that causes instability of the cervical spine Patients with limited neck extension and flexion movement Patients with large neck masses T88.4 Failed or difficult intubation Treatment - Devices Treatment - Devices Intervention group: In the intervention group (M), the patient is placed in a supine position on a modified RAMP (a trapezoidal device with a height of 15 cm, and a length of 80 cm, with an angle of 30 degrees, which has a length of 20 cm and 80 cm). .)At the entrance to the operating room, an airway evaluation is performed for patients (including Malampati score, Cormac Lehan, thyromental distance, mouth opening, and neck extension).Prior to surgery, patients will receive IV isotonic fluid. Before induction of anesthesia, conventional monitors including electrocardiogram, non-invasive blood pressure monitor and pulse oximetry will be used for evaluation. For induction of anesthesia, 1-2 mg / kg propofol, 0.1 mg / kg cis atracurium and 0.2 μg / kg sufentanil are used.Also, ventilation mask using face mask, 3 minutes before induction is done as current volume ventilation, then with tube number 7 - 7.5 - 8 by the same anesthesiologist and using Macintosh laryngoscope intubation is done. The correct position of the endotracheal tube is confirmed by capnography and after intubation, the patient returns to the standard position after 10 minutes with caution.Then, 6 to 12 hours after the operation, the patient's satisfaction is recorded based on the patient's general condition and the feeling of pain after intubation by visual analog scale. Control group: n the control group (S), patients are usually placed in the supine position and a pillow 10 cm high is placed under the patient's head.At the entrance to the operating room, an airway evaluation is performed for patients (including Malampati score, Cormac Lehan, thyromental distance, mouth opening, and neck extension).Prior to surgery, patients will receive IV isotonic fluid. Before induction of anesthesia, conventional monitors including electrocardiogram, non-invasive blood pressure monitor and pulse oximetry will be used for evaluation. For induction of anesthesia, 1-2 mg / kg propofol, 0.1 mg / kg cis atracurium and 0.2 μg / kg sufentanil are used.Also, ventilation mask using face mask, 3 minutes before induction is done as current volume ventilation, then with tube number 7 - 7.5 - 8 by the same anesthesiologist and using Macintosh laryngoscope intubation is done. The correct position of the endotracheal tube is confirmed by capnography and after intubation, the patient returns to the standard position after 10 minutes with caution.Then, 6 to 12 hours after the operation, the patient's satisfaction is recorded based on the patient's general condition and the feeling of pain after intubation by visual analog scale. Duration of intubation. Timepoint: At the beginning of the study. Method of measurement: Measuring intubation time in seconds (with the help of a blind person to the type of intervention). Number of attempts for successful intubation. Timepoint: At the beginning of the study. Method of measurement: Counting the number of times intubation (with the help of a blind person to the type of intubation intervention). Patient satisfaction. Timepoint: 12 hours after surgery. Method of measurement: Based on the Visual Analogue Scale. Ghoum University of Medical Sciences Approved 2022-05-10 Ethics Committee in Biomedical Research, Qom University of Medical Sciences No. 20, Valiasr Ave., artesh Blvd., aqdasiyeh Tehran Tehran Iran (Islamic Republic of)