Mask Study: One-handed vs. Two Handed Technique in Children

Study Overview
=================
Brief 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.

Official Title
-----------------
Comparative Evaluation of One Handed Versus Two Handed Mask Holding Techniques in Children During Induction of Anesthesia

Conditions
-----------------
Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Procedure: One handed mask airway, switch to two hands
* Procedure: Two handed mask airway + jaw thrust
* Procedure: Two handed mask airway, switch to one hand


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between 1 to 8 years of age Scheduled for Tonsillectomy & adenoidectomy Documented evidence of obstructive sleep apnea ASA I and II Exclusion Criteria: Children with abnormal airway anatomy ASA III and over

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 8 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: One handed mask airway, switch to two hands<br>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 | Procedure: One handed mask airway, switch to two hands<br>* 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.<br>|
| Active Comparator: Two handed mask airway + jaw thrust<br>Induction of anesthesia started as follows while children are breathing spontaneously: Two handed mask airway + jaw thrust - 40 sec | Procedure: Two handed mask airway + jaw thrust<br>* 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.<br>|
| Active Comparator: Two handed mask airway, switch to one hand<br>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 | Procedure: Two handed mask airway, switch to one hand<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Work of breathing | Phase angle | 20 - 40 seconds | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Airway Obstruction Rating Scale 0 - 3 | Presence of airway obstruction: 0= No obstruction; 1=Good gas exchange with noisy breathing, no retractions; 2=Mild retractions with diminished air flow; 3=Severe retractions with minimal/no air flow | 20-40 seconds | 
| Laryngospasm | Indicate presence: yes/no | 20-40 seconds | 
| Breath holding | Indicate presence: yes/no | 20-40 seconds | 
| Labored breathing | labored breathing index (RCI) | 20-40 seconds | 
| Rib cage movement | %Rib Cage movement (%RC) | 20-40 seconds |