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

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: 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

• Registration Number: NCT03215121
• Lead Sponsor: Nemours Children's Clinic

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.

Study Timeline

• Study First Submitted: 2017-07-07
• Study First Submitted QC: 2017-07-10
• Study First Posted: 2017-07-12
• Study Start: 2018-04-01
• Primary Completion: 2019-08-31
• Status Verified: 2020-01
• Study Completion: 2020-01-22
• Last Update Submitted: 2020-01-22
• Last Update Posted: 2020-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Between 1 to 8 years of age Scheduled for Tonsillectomy & adenoidectomy Documented evidence of obstructive sleep apnea ASA I and II

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Exclusion Criteria

• Children with abnormal airway anatomy ASA III and over

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
One handed mask airway, switch to two hands	One handed mask airway, switch to two hands	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
Two handed mask airway + jaw thrust	Two handed mask airway + jaw thrust	Induction of anesthesia started as follows while children are breathing spontaneously: Two handed mask airway + jaw thrust - 40 sec
Two handed mask airway, switch to one hand	Two handed mask airway, switch to one hand	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

Primary Outcome Measures

Name	Time	Method
Work of breathing	20 - 40 seconds	Phase angle

Secondary Outcome Measures

Name	Time	Method
Airway Obstruction Rating Scale 0 - 3	20-40 seconds	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
Laryngospasm	20-40 seconds	Indicate presence: yes/no
Breath holding	20-40 seconds	Indicate presence: yes/no
Labored breathing	20-40 seconds	labored breathing index (RCI)
Rib cage movement	20-40 seconds	%Rib Cage movement (%RC)

Trial Locations

Locations (1)

Nemours/A I duPont Hospital for Children; 🇺🇸 Wilmington, Delaware, United States