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Ventilator LungNCT03558620

Effect of an Endoscopic Bite Block on Mask Ventilation

A study testing mask ventilation in people with Ventilator Lung, run by SMG-SNU Boramae Medical Center at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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.) Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Ventilator Lung
What is being tested?
mask ventilation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
1 siteSouth Korea
Study dates
7 Jun 2018to 12 Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul Metropolitan Government Seoul National University Boramae Medical Center

    Seoul, 156-707

Other trials in South Korea

About this study

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

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.)

Read the 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.)

Conditions
Ventilator Lung
Being tested
mask ventilation
Keywords
manual ventilation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mask ventilationProcedure or surgery

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

Study groups in NCT03558620
Study groupRoleWhat they receive
Group 1O2ExperimentalA fitting mask is held by one hand -> one hand with an endoscopic bite block -> held by two hands
Receives: Procedure: mask ventilation
Group 12OExperimentalA fitting mask is held by one hand -> held by two hands-> one hand with an endoscopic bite block
Receives: Procedure: mask ventilation
Group O12ExperimentalA fitting mask is held by one hand with an endoscopic bite block->by one hand -> by two hands
Receives: Procedure: mask ventilation
Group O21ExperimentalA fitting mask is held by one hand with an endoscopic bite block -> by two hands-> one hand
Receives: Procedure: mask ventilation
Group 21OExperimentalA fitting mask is held by two hands -> one hand -> one hand with an endoscopic bite block
Receives: Procedure: mask ventilation
Group 2O1ExperimentalA fitting mask is held by two hands ->one hand with an endoscopic bite block-> by one hand
Receives: Procedure: mask ventilation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: during mask ventilation after anesthesia induction

Secondary outcomes (2)

  1. Minute ventilation

    Minute ventilationwith one-hand mask ventilation, one-handed mask ventilation with an endoscopic bite block, and two-handed ventilation

    Measured: during mask ventilation after anesthesia induction

  2. 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.

    Measured: during mask ventilation after anesthesia induction

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2018
  2. Study start7 Jun 2018
  3. Primary completion12 Dec 2018
  4. Study completion12 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03558620
Sponsor's protocol ID
2018/00/0000
Status last verified
Mar 2019
First submitted
26 Apr 2018
Last updated
2 Apr 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 23473817

  • 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.

    PubMed 20808210

  • 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.

    PubMed 18853942

Questions about this trial

What is this clinical trial studying?

A study testing mask ventilation in people with Ventilator Lung, run by SMG-SNU Boramae Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Expiratory tidal volume (time frame: during mask ventilation after anesthesia induction). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03558620, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2019.

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