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

NCT03215121 | Completed

• 1 other identifier: 1065828-2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Work of breathing

  Phase angle

  20 - 40 seconds

Secondary Outcomes (5)

• Airway Obstruction Rating Scale 0 - 3

  20-40 seconds

• Laryngospasm

  20-40 seconds

• Breath holding

  20-40 seconds

• Labored breathing

  20-40 seconds

• Rib cage movement

  20-40 seconds

Study Arms (3)

One handed mask airway, switch to two hands

ACTIVE COMPARATOR

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

Two handed mask airway + jaw thrust

ACTIVE COMPARATOR

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

Two handed mask airway, switch to one hand

ACTIVE COMPARATOR

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

Interventions

One handed mask airway, switch to two hands PROCEDURE

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.

One handed mask airway, switch to two hands

Two handed mask airway + jaw thrust PROCEDURE

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 + jaw thrust

Two handed mask airway, switch to one hand PROCEDURE

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.

Two handed mask airway, switch to one hand

Eligibility Criteria

• Age: 1 Year - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Children with abnormal airway anatomy ASA III and over

Sponsors & Collaborators

• Nemours Children's Clinic: lead

Study Sites (1)

Nemours/A I duPont Hospital for Children

Wilmington, Delaware, 19803, United States

Location

Related Publications (9)

• 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.

  PMID: 11093984 BACKGROUND

• 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.

  PMID: 15725313 BACKGROUND

• 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.

  PMID: 9803430 BACKGROUND

• 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.

  PMID: 28289485 BACKGROUND

• Kheterpal S. It's About Time. Anesthesiology. 2017 Jan;126(1):4-5. doi: 10.1097/ALN.0000000000001408. No abstract available.

  PMID: 27811484 BACKGROUND

• 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.

  PMID: 27811485 BACKGROUND

• 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.

  PMID: 10781266 BACKGROUND

• 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.

  PMID: 17065880 BACKGROUND

• 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.

  PMID: 19293691 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Anesthesiologist and Director of Pain Service, Principal Investigator, Associate Professor of Anesthesiology

Model Details: 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.

Study Record Dates

• First Submitted: July 7, 2017
• First Posted: July 12, 2017
• Study Start: April 1, 2018
• Primary Completion: August 31, 2019
• Study Completion: January 22, 2020
• Last Updated: January 23, 2020

Record last verified: 2020-01

Locations

US (1)