Effect of an Endoscopic Bite Block on Mask Ventilation

NCT ID: NCT03558620

Last Updated: 2019-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-07

Study Completion Date

2018-12-12

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.)

Conditions

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Ventilator Lung

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group 1O2

A fitting mask is held by one hand -\> one hand with an endoscopic bite block -\> held by two hands

Group Type EXPERIMENTAL

mask ventilation

Intervention Type PROCEDURE

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

Group 12O

A fitting mask is held by one hand -\> held by two hands-\> one hand with an endoscopic bite block

Group Type EXPERIMENTAL

mask ventilation

Intervention Type PROCEDURE

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

Group O12

A fitting mask is held by one hand with an endoscopic bite block-\>by one hand -\> by two hands

Group Type EXPERIMENTAL

mask ventilation

Intervention Type PROCEDURE

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

Group O21

A fitting mask is held by one hand with an endoscopic bite block -\> by two hands-\> one hand

Group Type EXPERIMENTAL

mask ventilation

Intervention Type PROCEDURE

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

Group 21O

A fitting mask is held by two hands -\> one hand -\> one hand with an endoscopic bite block

Group Type EXPERIMENTAL

mask ventilation

Intervention Type PROCEDURE

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

Group 2O1

A fitting mask is held by two hands -\>one hand with an endoscopic bite block-\> by one hand

Group Type EXPERIMENTAL

mask ventilation

Intervention Type PROCEDURE

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

Interventions

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mask ventilation

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

Intervention Type PROCEDURE

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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SMG-SNU Boramae Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jin-Young Hwang

Associate professor, Department of Anesthesiology and Pain medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jin-Young Hwang, M.D., phD

Role: PRINCIPAL_INVESTIGATOR

Seoul Metropolitan Government Seoup National University Boramae Medical Center

Locations

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Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 23473817 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20808210 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18853942 (View on PubMed)

Other Identifiers

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2018/00/0000

Identifier Type: -

Identifier Source: org_study_id

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