Mask Study: One-handed vs. Two Handed Technique in Children
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      During induction of anesthesia in children, the investigators have observed significant
      variability in mask holding technique at our institution among different anesthesia
      practitioners. Some hold the face mask using one hand and others use two hands. The aim of
      our study is to comparatively evaluate the extent of airway obstruction in children whilst
      anesthetic mask is held with one hand with jaw thrust versus mask held using two hands with
      chin lift by anesthesia provider during induction of anesthesia in children.
    

Detailed description: 
      In a prospective, randomized and controlled study, 60 children with documented obstructive
      sleep apnea (from sleep study or history obtained from the parent of bothersome snoring,
      witnessed apnea which interrupts the snoring and/or gasping and choking sensations that
      arouse the patient from sleep) due to enlarged tonsils and adenoid scheduled for
      tonsillectomy and adenoidectomy surgery will be enrolled in the study. Children will be
      randomly divided in three groups of 20 each based on the induction technique used:

      Group --1: Induction of anesthesia started as follows while children are breathing
      spontaneously: One handed mask airway + chin lift - 20 sec and then switch to two hands + jaw
      thrust - 20 sec

      Group 2 - Induction of anesthesia started as follows while children are breathing
      spontaneously: Two handed mask airway + jaw thrust - 40 sec

      Group 3 - Induction of anesthesia started as follows while children are breathing
      spontaneously: Two handed mask airway + jaw thrust - 20 sec and then switch to one hand +
      chin lift- 20 sec

      Premedication with midazolam as per standard protocol, will be administered prior to taking
      the patients to the operating room. Prior to the induction of anesthesia, a shoulder role
      will be used to have the child's head in sniffing position for induction. Horizontal
      alignment of the external auditory meatus with the sternum, will be used as a marker for,
      proper positioning.

      Oxygen and nitrous oxide for 10-15 seconds will be administered and sevoflurane will then be
      commenced. Addition of sevoflurane will be recorded as the start of induction. The provider
      will hold the mask as randomized, one hand with switch to two hands for Group 1 patients, two
      hands for Group 2 patients and two hands with switch to one hand for Group 3 patients. Any
      changes in airway patency when mask is held by one hand versus two hands will be observed and
      documented by various parameters stated below. The initial mask management will be performed
      for 20 seconds.

      After another 20 seconds (50 seconds from the start of induction), mask holding will switch
      to two hands for 20 seconds. In Group 2 patients mask will be held with two hands for 40
      seconds. No oropharyngeal or nasopharyngeal airway will be placed during the study period. In
      Group 3 patients, mask will initially be held with two hands for 20 seconds, with switch to
      one hand for 20 seconds.

      In the investigators clinical experience, the rate of obstructive symptoms with one hand
      ventilation approaches 100% and obstructive symptoms with two hands ventilation approaches
      0%. Using this ratio data for a power analysis to determine sample size yielded 4 subjects
      per group. As this is probably unreasonably low, the ratios were adjusted to 75% for one hand
      and 25% for two hand ventilation, which yielded 18 subjects per group to achieve an alpha of
      95%, and beta of 80%. With the potential for case dropout, the sample sizes for this study
      were set at 20 per group to reasonably ensure statistical significance. Given that
      approximately 80 cases of tonsillectomy and adenoidectomy cases are performed due to
      obstruction a year, this sample size should be easily obtainable. Randomization of patient
      assignment to the groups will be accomplished by graph pad quickcalcs.

      (http://www.graphpad.com/quickcalcs/randomize1.cfm).

      Continuous variables, times and ratio data will be analyzed by t test and nominal data by chi
      square.
    

Intervention name(s): One handed mask airway, switch to two hands; Two handed mask airway + jaw thrust; Two handed mask airway, switch to one hand
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Prior to the induction of anesthesia, a shoulder role will be used to have the child's head in sniffing position for induction. Horizontal alignment of the external auditory meatus with the sternum, will be used as a marker for, proper positioning.
Oxygen and nitrous oxide for 10-15 seconds will be administered and sevoflurane will then be commenced.The provider will hold the mask as randomized, one hand mask airway with switch to two hand for Group 1 patients. Any changes in airway patency when mask is held by one hand versus two hands will be observed and documented by various parameters. The initial mask management will be performed for 20 seconds.
After another 20 seconds (50 seconds from the start of induction), in Group one, the mask holding will switch to two hands for 20 seconds.; Prior to the induction of anesthesia, a shoulder role will be used to have the child's head in sniffing position for induction. Horizontal alignment of the external auditory meatus with the sternum, will be used as a marker for, proper positioning.
Oxygen and nitrous oxide for 10-15 seconds will be administered and sevoflurane will then be commenced.The provider will hold the mask as randomized, two hands for Group two patients. Any changes in airway patency when mask is held by one hand versus two hands will be observed and documented by various parameters. In Group 2 patient's mask will be held with two hands first for 40 seconds.; Prior to the induction of anesthesia, a shoulder role will be used to have the child's head in sniffing position for induction. Horizontal alignment of the external auditory meatus with the sternum, will be used as a marker for, proper positioning.
Oxygen and nitrous oxide for 10-15 seconds will be administered and sevoflurane will then be commenced.The provider will hold the mask as randomized, two hands for Group 3 patients. Any changes in airway patency when mask is held by one hand versus two hands will be observed and documented by various parameters. The initial mask management will be performed for 20 seconds.
After another 20 seconds (50 seconds from the start of induction), in Group 3, the mask holding will switch to one hand for 20 seconds.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Childrenwith documented obstructive sleep apnea (by sleep study or history obtained from the parent) due to enlarged tonsils and adenoid scheduled for tonsillectomy and adenoidectomy surgery will be enrolled in the study. Children will be randomly divided in two groups of 20 each based on the induction technique used:
Group --1: Induction of anesthesia started as follows while children are breathing spontaneously: One handed mask airway + chin lift - 20 sec and then switch to two hands + jaw thrust - 20 sec Group - 2: Induction of anesthesia started as follows while children are breathing spontaneously: Two handed mask airway + jaw thrust - 40 sec.
Group 3 - Induction of anesthesia started as follows while children are breathing spontaneously. Two handed mask airway + jaw thrust - 20 sec. then switch to one hand + chin lift - 20 sec.
Masking: None (Open Label)
Primary purpose: Diagnostic