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IRCT20190127042511N2 IRCT 2021-11-29 Esfahan University of Medical Sciences Comparison of four insertion techniques of laryngeal mask airway: standard, 90-degree rotation, 180-degree rotation and insertion with thumb finger Comparison of four insertion techniques of laryngeal mask airway: standard, 90-degree rotation, 180-degree rotation and insertion with thumb finger 2021-11-11 anticipated 252 Complete https://irct.ir/trial/60142 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For the block randomization method, the letter A is used to place patients in the "standard" group, the letter B is used for the "90 degree rotation" group, the letter C is used for the "180 degree rotation" group, and the number D is used for the "thumb placement" group. The size of all blocks is equal and in this four-group experiment, we use 4 blocks (including one person in group A, one person in group B and one person in group C, and one person in group D) that use soft Random sequence generation software will be obtained. Also, in order to hide the random sequence on the participants, opaque sealed envelopes sealed with random sequences are used and each sequence is recorded on a card, and the cards are placed in the envelopes respectively. Based on the order of entry of eligible participants in the research, the envelopes are opened in order and the assigned group of the participant is determined, Blinding description: Patients are not aware of being in groups. LMA insertion and data entry is performed by an experienced anesthesiologist. The information analyzer does not know about individuals (coding). N/A Insertion of LMA. Intervention 1: Control group: Standard method of LMA insertion ; In this method, the LMA mask is inserted using the index finger and advanced to the palatopharyngeal flexion to reach the hypopharynx to finally reach a real resistance. Intervention 2: Intervention group: 90 degree rotation method of LMA insertion ؛ In this method, the LMA mask is inserted into the mouth in such a way that its inner layer is towards the buccal mucus and the corner of the mouth. Here the mask is pushed forward to finally hit the resistance. Intervention 3: Intervention group: 180 degree rotation method of LMA insertion ؛ In this method, the LMA mask is inserted into the mouth while the inner layer is placed towards the hard palate (contrary to the standard method) and is pushed forward until it encounters resistance. The LMA mask is then rotated 180 degrees and the cuff is inflated. Intervention 4: Intervention group: LMA insertion with thumb finger ؛In this method, the anesthesiologist first places the patient on the patient's face in front of the patient's chest and right arm. After partially inflating the cuff (equivalent to half the air recommended for inflating the mask), the posterior surface of the cuff will be lubricated with a blue water-based gel.The patient's head is supported by a tight ring while the patient's neck is flex and the patient's head is extended. The tubular part of the laryngeal mask is held in an automatic manner, and unlike the standard method, the part connected to the tube is taken with the thumb. After opening the patient's mouth, the head of the mask is placed opposite the inner surface of the upper canines, while its opening is towards the front. The mask is then pressed against the hard palate to reach the hypopharyngeal area and resist. In this method, the thumb will be used to apply pressure against the hard palate and push the LMA mask forward. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified individuals When: Six months after the results were published To whom: Academic researchers Conditions: Scientific uses Where to obtain: Isfahan University of Medical Sciences website How to obtain: Clear request on the site for access to data by the individual and then review the request by the research assistant within 2 weeks and then permission to access the data. Comments:
public Seyed Jalal Hashemi
Hezarjerib Ave
Isfahan Iran (Islamic Republic of) 8118132554 +98 31 3224 3652 J_hashemi@med.mui.ac.ir Esfahan University of Medical Sciences scientific Seyed Jalal Hashemi
Hezarjerib Ave
Isfahan Iran (Islamic Republic of) 8118132554 +98 31 3224 3652 J_hashemi@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) ASA 1 or 2 Age 18 to 80 years 18 years 80 years Both People with difficult airway with mouth openin less than 2.5 cm People at high risk for aspiration include non-fasting people with gastroesophageal reflux disease and pregnancy Patients with a history of sore throat in a recent month History of head, neck and stomach surgery Colds in the last 10 days Difficult intubation (mallampati> 3, TMD> 6.5) Coagulopathy BMI>30 Treatment - Devices Treatment - Devices Treatment - Devices Treatment - Devices Control group: Standard method of LMA insertion ; In this method, the LMA mask is inserted using the index finger and advanced to the palatopharyngeal flexion to reach the hypopharynx to finally reach a real resistance. Intervention group: 90 degree rotation method of LMA insertion ؛ In this method, the LMA mask is inserted into the mouth in such a way that its inner layer is towards the buccal mucus and the corner of the mouth. Here the mask is pushed forward to finally hit the resistance. Intervention group: 180 degree rotation method of LMA insertion ؛ In this method, the LMA mask is inserted into the mouth while the inner layer is placed towards the hard palate (contrary to the standard method) and is pushed forward until it encounters resistance. The LMA mask is then rotated 180 degrees and the cuff is inflated. Intervention group: LMA insertion with thumb finger ؛In this method, the anesthesiologist first places the patient on the patient's face in front of the patient's chest and right arm. After partially inflating the cuff (equivalent to half the air recommended for inflating the mask), the posterior surface of the cuff will be lubricated with a blue water-based gel.The patient's head is supported by a tight ring while the patient's neck is flex and the patient's head is extended. The tubular part of the laryngeal mask is held in an automatic manner, and unlike the standard method, the part connected to the tube is taken with the thumb. After opening the patient's mouth, the head of the mask is placed opposite the inner surface of the upper canines, while its opening is towards the front. The mask is then pressed against the hard palate to reach the hypopharyngeal area and resist. In this method, the thumb will be used to apply pressure against the hard palate and push the LMA mask forward First try attempt success rate of LMA insertion. Timepoint: After LMA insertion. Method of measurement: Observation. Mean arterial pressure. Timepoint: 1min before LMA insertion and 1 , 5 min after interion. Method of measurement: NIBP. End tidal CO2. Timepoint: After insertion. Method of measurement: Capnography. Spo2. Timepoint: Base time (at rest),1min before LMA insertion and 1,5 min after insertion. Method of measurement: Puls oximeter. Heart rate. Timepoint: Base time (at rest),1min before LMA insertion and 1,5 min after insertion. Method of measurement: Monitoring. Side effects of masking include laryngospasm; blood on the mask; sore throat. Timepoint: When LMA removed. Method of measurement: Observation. Calf air pressure need to prevent leakage. Timepoint: After insertion of LMA. Method of measurement: barometer. Need for repositioning. Timepoint: At time of insertion. Method of measurement: Observation. Attempts for insertion (1,2 or 3 times). Timepoint: At time of insertion. Method of measurement: Observation. Total successful rate of LMA intertion. Timepoint: At time of insertion. Method of measurement: Observation. Esfahan University of Medical Sciences Approved 2021-11-02 Ethics committee of Isfahan University of Medical Sciences Hezar Jerib Ave Isfahan Isfehan Iran (Islamic Republic of)