Effect of an Endoscopic Bite Block on Mask Ventilation

Effect of an Endoscopic Bite Block on Mask Ventilation in Anesthetized and Paralyzed Patients

Evaluation of effects of an endoscopic bite block on mask ventilation. In the present study, expiratory tidal volume and minute ventilation are measured under same pressure controlled mode in ventilator with three kinds of holding a mask. ( by one hand, one hand with an endoscopic bite block and two hand hold.)

Study Overview

• Status: Completed
• Conditions: Ventilator Lung
• Intervention / Treatment: Procedure: mask ventilation

Detailed Description

Evaluation of effects of an endoscopic bite block on mask ventilation. In the present study, expiratory tidal volume and minute ventilation are measured under the same pressure controlled mode in ventilator (Pressure 15cmH2O, Respiratory rate 15/min, I:E=1:1) with three kinds of holding a mask. ( by one hand, one hand with an endoscopic bite block and two hand hold.)

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 156-707
    • Seoul Metropolitan Government Seoul National University Boramae Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients scheduled for elective surgery under general anesthesia and agree with the purpose of the study

Exclusion Criteria:

• patients with diseases or structural abnormalities in the upper airway, wobbly teeth, and limited mouth opening of less than 3.5 cm or those who were at risk of aspiration

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1O2; A fitting mask is held by one hand -> one hand with an endoscopic bite block -> held by two hands	Procedure: mask ventilation; mask ventilation (one-handed ventilation, one-handed with an endoscopic bite block, and two-handed ventilation)
Experimental: Group 12O; A fitting mask is held by one hand -> held by two hands-> one hand with an endoscopic bite block	Procedure: mask ventilation; mask ventilation (one-handed ventilation, one-handed with an endoscopic bite block, and two-handed ventilation)
Experimental: Group O12; A fitting mask is held by one hand with an endoscopic bite block->by one hand -> by two hands	Procedure: mask ventilation; mask ventilation (one-handed ventilation, one-handed with an endoscopic bite block, and two-handed ventilation)
Experimental: Group O21; A fitting mask is held by one hand with an endoscopic bite block -> by two hands-> one hand	Procedure: mask ventilation; mask ventilation (one-handed ventilation, one-handed with an endoscopic bite block, and two-handed ventilation)
Experimental: Group 21O; A fitting mask is held by two hands -> one hand -> one hand with an endoscopic bite block	Procedure: mask ventilation; mask ventilation (one-handed ventilation, one-handed with an endoscopic bite block, and two-handed ventilation)
Experimental: Group 2O1; A fitting mask is held by two hands ->one hand with an endoscopic bite block-> by one hand	Procedure: mask ventilation; mask ventilation (one-handed ventilation, one-handed with an endoscopic bite block, and two-handed ventilation)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expiratory tidal volume	Expiratory tidal volume with one-hand mask ventilation, one-handed mask ventilation with an endoscopic bite block, and two-handed ventilation	during mask ventilation after anesthesia induction

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minute ventilation	Minute ventilationwith one-hand mask ventilation, one-handed mask ventilation with an endoscopic bite block, and two-handed ventilation	during mask ventilation after anesthesia induction
Incidence of inadequate ventilation or dead space ventilation	Inadequate mask ventilation and dead-space ventilation are defined as a mean expiratory tidal volume of less than 4 mL kg-1 of predicted body weight and a mean expiratory tidal volume of less than 150 mL per breath with no clinical signs, respectively.	during mask ventilation after anesthesia induction

Collaborators and Investigators

• Sponsor: SMG-SNU Boramae Medical Center
• Investigators: Principal Investigator: Jin-Young Hwang, M.D., phD, Seoul Metropolitan Government Seoup National University Boramae Medical Center

Publications and helpful links

General Publications

• Hart D, Reardon R, Ward C, Miner J. Face mask ventilation: a comparison of three techniques. J Emerg Med. 2013 May;44(5):1028-33. doi: 10.1016/j.jemermed.2012.11.005. Epub 2013 Mar 7.
• Joffe AM, Hetzel S, Liew EC. A two-handed jaw-thrust technique is superior to the one-handed "EC-clamp" technique for mask ventilation in the apneic unconscious person. Anesthesiology. 2010 Oct;113(4):873-9. doi: 10.1097/ALN.0b013e3181ec6414.
• Walsh JH, Maddison KJ, Platt PR, Hillman DR, Eastwood PR. Influence of head extension, flexion, and rotation on collapsibility of the passive upper airway. Sleep. 2008 Oct;31(10):1440-7.

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2018
• Primary Completion (Actual): December 12, 2018
• Study Completion (Actual): December 12, 2018

Study Registration Dates

• First Submitted: April 26, 2018
• First Submitted That Met QC Criteria: June 14, 2018
• First Posted (Actual): June 15, 2018

Study Record Updates

• Last Update Posted (Actual): April 2, 2019
• Last Update Submitted That Met QC Criteria: March 29, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: manual ventilation
• Other Study ID Numbers: 2018/00/0000

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No