CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
One handed mask airway, switch to two hands +2 moreprocedure
Likely dose
Not stated in record
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Search/NCT03215121
NCT03215121N/ACompleted

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

Nemours Children's Clinic·interventional·Posted Jul 12, 2017·Updated Jan 23, 2020

In Brief

A clinical study evaluating One handed mask airway, switch to two hands, Two handed mask airway + jaw thrust, and 1 other intervention for Obstructive Sleep Apnea. Completed, enrolled 60 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJul 12, 2017
Enrollment StartApr 1, 2018
Primary CompletionAug 31, 2019
Study CompletionJan 22, 2020
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 9.0 years ago

Interventions

One handed mask airway, switch to two handsprocedure

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.

Two handed mask airway + jaw thrustprocedure

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.

Two handed mask airway, switch to one handprocedure

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.