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

Compare ventilation quality of two different mask holding techniques (three finger grip with and without submental maneuver) in infants (<1 y/o)

A double-blind randomized controlled trial with a parallel group design on 90 patients

This is an interventional study of infants undergoing elective surgery with general anesthesia in Children's Medical Center. After obtaining written informed consent from the guardians of the infants, patients are allocated to one of the interventional groups randomly, using the randomization.com website. After connecting the standard monitoring devices, general anesthesia is induced with 8% sevoflurane and 100% oxygen (flow=2lit/min) using one of the mask holding techniques (three finger grip with/without submental maneuver) in neutral position before intubation. Demographic data (age, sex, weight and height) for each patient is collected. Quantitative hemodynamic parameters (blood pressure, pulse rate & O2 saturation), expiratory tidal volume (quality of the patient's breath flow to the hyperinflation bag), abnormal respiratory sounds and respiratory distress are evaluated by a single experienced anesthesiologist and recorded by a third person unaware of the patient's group, during mask ventilation. End-tidal CO2 pressure is measured immediately after intubation. In case of any unexpected event, the necessary actions will be taken.

Inclusion Criteria: Infants; ASA 1, 2; elective surgery; general anesthesia Exclusion Criteria: history of respiratory disease; maxillofacial anomalies; chest wall deformity; any object interfering with mask ventilation

Group 1: three finger grip Group 2: three finger grip with submental maneuver

Expiratory tidal volume; End-tidal CO2 pressure; O2 sat; SBP and DBP; PR; Respiratory sounds and respiratory distress

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.

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.