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

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
One handed mask airway, switch to two hands
Two handed mask airway + jaw thrust
Two handed mask airway, switch to one hand
Sponsored by
Nemours Children's Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Obstructive Sleep Apnea

Eligibility Criteria

1 Year - 8 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Nemours/A I duPont Hospital for Children

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

One handed mask airway, switch to two hands

Two handed mask airway + jaw thrust

Two handed mask airway, switch to one hand

Arm Description

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

Induction of anesthesia started as follows while children are breathing spontaneously: Two handed mask airway + jaw thrust - 40 sec

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

Outcomes

Primary Outcome Measures

Work of breathing
Phase angle

Secondary Outcome Measures

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
Laryngospasm
Indicate presence: yes/no
Breath holding
Indicate presence: yes/no
Labored breathing
labored breathing index (RCI)
Rib cage movement
%Rib Cage movement (%RC)

Full Information

First Posted
July 7, 2017
Last Updated
January 22, 2020
Sponsor
Nemours Children's Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03215121
Brief Title
Mask Study: One-handed vs. Two Handed Technique in Children
Official Title
Comparative Evaluation of One Handed Versus Two Handed Mask Holding Techniques in Children During Induction of Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
August 31, 2019 (Actual)
Study Completion Date
January 22, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nemours Children's Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
One handed mask airway, switch to two hands
Arm Type
Active Comparator
Arm Description
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
Arm Title
Two handed mask airway + jaw thrust
Arm Type
Active Comparator
Arm Description
Induction of anesthesia started as follows while children are breathing spontaneously: Two handed mask airway + jaw thrust - 40 sec
Arm Title
Two handed mask airway, switch to one hand
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
One handed mask airway, switch to two hands
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Two handed mask airway + jaw thrust
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Two handed mask airway, switch to one hand
Intervention Description
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.
Primary Outcome Measure Information:
Title
Work of breathing
Description
Phase angle
Time Frame
20 - 40 seconds
Secondary Outcome Measure Information:
Title
Airway Obstruction Rating Scale 0 - 3
Description
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
Time Frame
20-40 seconds
Title
Laryngospasm
Description
Indicate presence: yes/no
Time Frame
20-40 seconds
Title
Breath holding
Description
Indicate presence: yes/no
Time Frame
20-40 seconds
Title
Labored breathing
Description
labored breathing index (RCI)
Time Frame
20-40 seconds
Title
Rib cage movement
Description
%Rib Cage movement (%RC)
Time Frame
20-40 seconds

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Nemours/A I duPont Hospital for Children
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11093984
Citation
Keidan I, Fine GF, Kagawa T, Schneck FX, Motoyama EK. Work of breathing during spontaneous ventilation in anesthetized children: a comparative study among the face mask, laryngeal mask airway and endotracheal tube. Anesth Analg. 2000 Dec;91(6):1381-8. doi: 10.1097/00000539-200012000-00014.
Results Reference
background
PubMed Identifier
15725313
Citation
von Ungern-Sternberg BS, Erb TO, Reber A, Frei FJ. Opening the upper airway--airway maneuvers in pediatric anesthesia. Paediatr Anaesth. 2005 Mar;15(3):181-9. doi: 10.1111/j.1460-9592.2004.01534.x. No abstract available.
Results Reference
background
PubMed Identifier
9803430
Citation
Litman RS, Kottra JA, Berkowitz RJ, Ward DS. Upper airway obstruction during midazolam/nitrous oxide sedation in children with enlarged tonsils. Pediatr Dent. 1998 Sep-Oct;20(5):318-20.
Results Reference
background
PubMed Identifier
28289485
Citation
Rahman T, Page R, Page C, Bonnefoy JR, Cox T, Shaffer TH. pneuRIPTM: A Novel Respiratory Inductance Plethysmography Monitor. J Med Device. 2017 Mar;11(1):0110101-110106. doi: 10.1115/1.4035546. Epub 2017 Jan 24.
Results Reference
background
PubMed Identifier
27811484
Citation
Kheterpal S. It's About Time. Anesthesiology. 2017 Jan;126(1):4-5. doi: 10.1097/ALN.0000000000001408. No abstract available.
Results Reference
background
PubMed Identifier
27811485
Citation
Sato S, Hasegawa M, Okuyama M, Okazaki J, Kitamura Y, Sato Y, Ishikawa T, Sato Y, Isono S. Mask Ventilation during Induction of General Anesthesia: Influences of Obstructive Sleep Apnea. Anesthesiology. 2017 Jan;126(1):28-38. doi: 10.1097/ALN.0000000000001407.
Results Reference
background
PubMed Identifier
10781266
Citation
Langeron O, Masso E, Huraux C, Guggiari M, Bianchi A, Coriat P, Riou B. Prediction of difficult mask ventilation. Anesthesiology. 2000 May;92(5):1229-36. doi: 10.1097/00000542-200005000-00009.
Results Reference
background
PubMed Identifier
17065880
Citation
Kheterpal S, Han R, Tremper KK, Shanks A, Tait AR, O'Reilly M, Ludwig TA. Incidence and predictors of difficult and impossible mask ventilation. Anesthesiology. 2006 Nov;105(5):885-91. doi: 10.1097/00000542-200611000-00007.
Results Reference
background
PubMed Identifier
19293691
Citation
Kheterpal S, Martin L, Shanks AM, Tremper KK. Prediction and outcomes of impossible mask ventilation: a review of 50,000 anesthetics. Anesthesiology. 2009 Apr;110(4):891-7. doi: 10.1097/ALN.0b013e31819b5b87.
Results Reference
background

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

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