Mask Study: One-handed vs. Two Handed Technique in Children
| Status: | Recruiting |
|---|---|
| Conditions: | Insomnia Sleep Studies, Pulmonary |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 1 - 8 |
| Updated: | 8/24/2018 |
| Start Date: | April 1, 2018 |
| End Date: | December 31, 2020 |
| Contact: | Dinesh K Choudhry, MD |
| Email: | Dinesh.Choudhry@nemours.org |
| Phone: | 302-651-4000 |
Comparative Evaluation of One Handed Versus Two Handed Mask Holding Techniques in Children During Induction of Anesthesia
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.
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.
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.
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.
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
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