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Completed

NCT Number: NCT03558620

Effect of an Endoscopic Bite Block on Mask Ventilation

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.)

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Key information

Conditions

Ventilator Lung

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, 156-707, South Korea

About this study

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.)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mask ventilation

Procedure

mask ventilation (one-handed ventilation, one-handed with an endoscopic bite block, and two-handed ventilation)

Primary outcomes

  1. Expiratory tidal volume

    Time frame: 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 outcomes

  1. Minute ventilation

    Time frame: 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

  2. Incidence of inadequate ventilation or dead space ventilation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

SMG-SNU Boramae Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 15, 2018
Registry last updated
Apr 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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