Effect of an Endoscopic Bite Block on Mask Ventilation

Study Overview
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Brief Summary
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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
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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.)

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

Conditions
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Ventilator Lung

Intervention / Treatment
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* Procedure: mask ventilation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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manual ventilation