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IRCT20221114056498N1 IRCT 2022-12-18 Tehran University of Medical Sciences Adding submental maneuver to three finger mask holding technique in general inhalation anesthesia A comparative study of face mask ventilation quality of two different mask holding techniques: three finger grip with and without sub-mental maneuver, in infants (0-1 year of age) under general inhalation anesthesia 2022-12-22 anticipated 90 Complete https://irct.ir/trial/66891 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The required sample size for this study is 90. Subjects were randomized into 2 blocks using the website www.randomization.com before beginning the investigation. 45 numbers out of the numbers 1-90 were allocated randomly to each intervention group (group 1: three finger grip without the submental maneuver, group 2: three finger grip with the submental maneuver). The number and its assigned technique were inserted in the data collection form for each patient. For example, it was specified that, for patient number 4 the threff finger grip technique without the submental maneuver should be performed. Only the researcher performing mask ventilation is aware of the patient's allocated group. The person in charge of collecting the data is unaware of the patient's group, Blinding description: Parents/guardians of the infant from whom written informed consent was obtained were unaware of the allocated group of the patient. Only the researcher performing mask ventilation was aware of the technique used for mask ventilation in each patient. Also, the monitor showing the parameters that were intended to be studied in this study and the hyperinflation bag were placed in a way that this researcher couldn't see them and was unaware of these parameters. The person collecting and writing the data from the monitor, not only was unaware of the mask holding technique for each patient, but also was positioned in a place that couldn't see the technique used by the researcher performing mask ventilation. N/A Face mask holding technique. Intervention 1: Pulse oximeter and the right-sized blood pressure cuff are attached to the patient and the patient is monitored. Anesthesia machine is turned on and ready. Anesthesia is induced by 100 percent O2 and 8% sevoflurane gas, using the three finger grip technique without the submental maneuver before intubation. Intervention 2: Pulse oximeter and the right-sized blood pressure cuff are attached to the patient and the patient is monitored. Anesthesia machine is turned on and ready. Anesthesia is induced by 100 percent O2 and 8% sevoflurane gas, using the three finger grip technique with the submental maneuver before intubation. 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 No further information exists
public Elahe Radmehr
No. 46, Shahid Taheri St., Nelson Mandella Blvd.
Tehran Iran (Islamic Republic of) 1966943965 +98 21 2202 8897 elahe75r@gmail.com Tehran University of Medical Sciences scientific Mehrdad Goudarzi
Children's Medical Center, Dr. Qarib St.
Tehran Iran (Islamic Republic of) 1419733151 +98 21 6147 9000 drgoudarzi@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Age under 1 year old ASA 1, 2 Candidate for elective surgery Undergoing general anesthesia no limit 12 months Both Presence of any maxillofacial anomalies Chest wall deformity Any past medical history of respiratory diseases Any foreign object interfering with mask ventilation T88.9 Complication of surgical and medical care, unspecified Treatment - Other Treatment - Other Pulse oximeter and the right-sized blood pressure cuff are attached to the patient and the patient is monitored. Anesthesia machine is turned on and ready. Anesthesia is induced by 100 percent O2 and 8% sevoflurane gas, using the three finger grip technique without the submental maneuver before intubation. Pulse oximeter and the right-sized blood pressure cuff are attached to the patient and the patient is monitored. Anesthesia machine is turned on and ready. Anesthesia is induced by 100 percent O2 and 8% sevoflurane gas, using the three finger grip technique with the submental maneuver before intubation. Expiratory tidal volume. Timepoint: During holding the mask. Method of measurement: Quality of patient's breath flow to the hyperinflation bag by an experienced anesthesiology attending (good-fair-bad). Tehran University of Medical Sciences Approved 2021-04-04 Children's Medical Center-Tehran University of Medical Sciences Dr. Qarib St. Tehran Tehran Iran (Islamic Republic of)