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IRCT20170516033992N6 IRCT 2021-01-06 Oroumia University of Medical Sciences Comparison of laryngeal mask insertion in pediatric airway management Comparison of standard and lateral methods of laryngeal mask airway insertion in pediatric airway management (Number of attempts to insert laryngeal mask, mucosal damage, duration of laryngeal mask insertion, airway pressure and chest movement) 2020-09-15 anticipated 68 Complete https://irct.ir/trial/52239 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, simple randomization took place in a way that numbers from 1 to 68 were written separately on paper pieces and put inside a blinded box. For each patient, a piece of paper was drawn out. If the number drawn for the patient was even it went to group A and if it was an odd number, patients were attributed to group B, Blinding description: Patients and their parents were unaware of being in the intervention groups and the clinical evaluator was unaware of the placement of patients in the study groups. 3 Inguinal hernia. Intervention 1: Intervention group: In the lateral method, the anesthetized patient's head is held with one hand, and the proximal part of the mask is inserted into the oral cavity with the same standard method so that the entire cuff is placed inside the mouth. Then rotate 45 degrees to the side so that only the side of the tongue is in contact with the side edge of the mask. Then use your thumb and forefinger to push the mask forward as much as possible to feel resistance to it. The mask is then rotated 45 degrees in the opposite direction of the previous rotation and placed in the midline position. Then, its cuff was filled to the standard size with a special manometer and its leakage was checked. Intervention 2: Control group: In the standard method, the anesthetized patient's head is held with one hand, the proximal part of the laryngeal mask is inserted into the oral cavity with the same standard method so that all the cuffs are inside the mouth. Then, we insert the airway mask into the mouth by the head extension. Next, we push the laryngeal mask using thumb and forefinger forward as much as possible to feel resistance. The mask is then placed in the midline position, and the cuff is filled to the standard size with a special manometer and leaks are checked. In this method, we do not rotate the head 45 degrees and according to the usual procedure, the laryngeal mask is inserted as routine. Yes - There is a plan to make this available What will be shared: Information can be provided without patients' names When: 1 year after completion of the study To whom: Faculty researchers Conditions: Just for research targets Where to obtain: Sending an email to Dr. Tohid Karami by academic researchers for sending anonymous data that takes about 2 weeks karami.tohid@gmail.com How to obtain: Just sending an email to DR. Tohid Karami karami.tohid@gmail.com Comments:
public Tohid Karami
No30., Jahad Sq., Resalat st., Uremia University of Medical Sciences, Uremia, Iran
urmia Iran (Islamic Republic of) 5715833631 +98 44 3193 7000 karami.tohid@gmail.com Oroumia University of Medical Sciences scientific Tohid Karami
No30., Jahad Sq., Resalat st., Uremia University of Medical Sciences, Uremia, Iran
Urmia Iran (Islamic Republic of) 5715833631 +98 44 3193 7000 karami.tohid@gmail.com Oroumia University of Medical Sciences Iran (Islamic Republic of) Patients candidates for selective inguinal hernia repair surgery ASA1 and ASA2 Obtaining informed consent 2 years 6 years Both ASA3 and higher patients ??? Children with upper airway infections Limitation of mouth opening Children with congenital heart disease Patients undergoing emergency surgery who are at risk of aspiration of gastric contents K40 Inguinal hernia Treatment - Devices Treatment - Devices Intervention group: In the lateral method, the anesthetized patient's head is held with one hand, and the proximal part of the mask is inserted into the oral cavity with the same standard method so that the entire cuff is placed inside the mouth. Then rotate 45 degrees to the side so that only the side of the tongue is in contact with the side edge of the mask. Then use your thumb and forefinger to push the mask forward as much as possible to feel resistance to it. The mask is then rotated 45 degrees in the opposite direction of the previous rotation and placed in the midline position. Then, its cuff was filled to the standard size with a special manometer and its leakage was checked Control group: In the standard method, the anesthetized patient's head is held with one hand, the proximal part of the laryngeal mask is inserted into the oral cavity with the same standard method so that all the cuffs are inside the mouth. Then, we insert the airway mask into the mouth by the head extension. Next, we push the laryngeal mask using thumb and forefinger forward as much as possible to feel resistance. The mask is then placed in the midline position, and the cuff is filled to the standard size with a special manometer and leaks are checked. In this method, we do not rotate the head 45 degrees and according to the usual procedure, the laryngeal mask is inserted as routine. Chest movement. Timepoint: Through anesthesia procedure in the operation room. Method of measurement: Observation (No movement, Partially good, Adequately good). Airway pressure. Timepoint: Through anesthesia procedure in the operation room. Method of measurement: Adjustable Pressure Limiting results. Time of Laryngeal mask insertion. Timepoint: Through anesthesia procedure in the operation room. Method of measurement: Clock. Mucous damage. Timepoint: After extracting the mask. Method of measurement: presence of blood on the mask. Times tried to put the laryngeal mask on. Timepoint: In time of getting the mask. Method of measurement: Observation. Oroumia University of Medical Sciences Approved 2020-09-13 Ethics committee of Urmia University of Medical Sciences No30., Jahad Sq., Resalat St., Urmia University of Medical Sciences, Urmia, Iran Urmia West Azarbaijan Iran (Islamic Republic of)