Effect of an Endoscopic Bite Block on Mask Ventilation

Not Applicable

Completed

• Conditions: Ventilator Lung
• Interventions: Procedure: mask ventilation

• Registration Number: NCT03558620
• Lead Sponsor: SMG-SNU Boramae Medical Center

Brief Summary

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.)

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 Timeline

• Study First Submitted: 2018-04-26
• Study Start: 2018-06-07
• Study First Submitted QC: 2018-06-14
• Study First Posted: 2018-06-15
• Primary Completion: 2018-12-12
• Study Completion: 2018-12-12
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-29
• Last Update Posted: 2019-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 21O	mask ventilation	A fitting mask is held by two hands -\> one hand -\> one hand with an endoscopic bite block
Group 12O	mask ventilation	A fitting mask is held by one hand -\> held by two hands-\> one hand with an endoscopic bite block
Group O12	mask ventilation	A fitting mask is held by one hand with an endoscopic bite block-\>by one hand -\> by two hands
Group 2O1	mask ventilation	A fitting mask is held by two hands -\>one hand with an endoscopic bite block-\> by one hand
Group O21	mask ventilation	A fitting mask is held by one hand with an endoscopic bite block -\> by two hands-\> one hand
Group 1O2	mask ventilation	A fitting mask is held by one hand -\> one hand with an endoscopic bite block -\> held by two hands

Primary Outcome Measures

Name	Time	Method
Expiratory tidal volume	during mask ventilation after anesthesia induction	Expiratory tidal volume with one-hand mask ventilation, one-handed mask ventilation with an endoscopic bite block, and two-handed ventilation

Secondary Outcome Measures

Name	Time	Method
Minute ventilation	during mask ventilation after anesthesia induction	Minute ventilationwith one-hand mask ventilation, one-handed mask ventilation with an endoscopic bite block, and two-handed ventilation
Incidence of inadequate ventilation or dead space ventilation	during mask ventilation after anesthesia induction	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.

Trial Locations

Locations (1)

Seoul Metropolitan Government Seoul National University Boramae Medical Center; 🇰🇷 Seoul, Korea, Republic of