NCT03558620

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.)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

June 7, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 15, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2018

Completed
Last Updated

April 2, 2019

Status Verified

March 1, 2019

Enrollment Period

6 months

First QC Date

April 26, 2018

Last Update Submit

March 29, 2019

Conditions

Ventilator Lung

Keywords

manual ventilation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Minute ventilation

    during mask ventilation after anesthesia induction

  • Incidence of inadequate ventilation or dead space ventilation

    during mask ventilation after anesthesia induction

Study Arms (6)

Group 1O2

EXPERIMENTAL

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

Procedure: mask ventilation

Group 12O

EXPERIMENTAL

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

Procedure: mask ventilation

Group O12

EXPERIMENTAL

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

Procedure: mask ventilation

Group O21

EXPERIMENTAL

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

Procedure: mask ventilation

Group 21O

EXPERIMENTAL

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

Procedure: mask ventilation

Group 2O1

EXPERIMENTAL

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

Procedure: mask ventilation

Interventions

mask ventilationPROCEDURE

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

Group 12OGroup 1O2Group 21OGroup 2O1Group O12Group O21

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, 156-707, South Korea

Location

Related Publications (3)

  • 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.

    PMID: 23473817BACKGROUND

  • 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.

    PMID: 20808210BACKGROUND

  • 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.

    PMID: 18853942BACKGROUND

Study Officials

  • Jin-Young Hwang, M.D., phD

    Seoul Metropolitan Government Seoup National University Boramae Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, Department of Anesthesiology and Pain medicine

Study Record Dates

First Submitted

April 26, 2018

First Posted

June 15, 2018

Study Start

June 7, 2018

Primary Completion

December 12, 2018

Study Completion

December 12, 2018

Last Updated

April 2, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)