Effect of Paratracheal Pressure on Mask Ventilation

NCT ID: NCT05388266

Last Updated: 2022-11-01

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

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-04

Study Completion Date

2022-10-20

Brief Summary

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This study aims to evaluate the effect of paratracheal pressure on mask ventilation in anesthetized obese patients in terms of expiratory tidal volume, and peak inspiratory pressure.

Detailed Description

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Conditions

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Ventilation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Paratracheal pressure

After the induction of anesthesia, paratracheal pressure is applied during mask ventilation.

Group Type EXPERIMENTAL

Mask ventilation

Intervention Type OTHER

Mask ventilation is performed under paratracheal pressure or no pressure in a randomized, crossover manner.

No pressure

After the induction of anesthesia, no pressure is applied during mask ventilation.

Group Type ACTIVE_COMPARATOR

Mask ventilation

Intervention Type OTHER

Mask ventilation is performed under paratracheal pressure or no pressure in a randomized, crossover manner.

Interventions

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Mask ventilation

Mask ventilation is performed under paratracheal pressure or no pressure in a randomized, crossover manner.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adult patients with a body mass index ≥ 30 kg.m-2 undergoing general anesthesia for elective surgery

Exclusion Criteria

* Structural abnormalities or diseases in the face, neck, upper airway, or esophagus
* Increased risk of aspiration (pregnancy)
* Carotid artery stenosis, cerebrovascular disease
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

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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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Seol T, Kim H, Chang JE, Kang Y, Hwang JY. Effect of paratracheal pressure on the effectiveness of mask ventilation in obese anesthetized patients: a randomized, cross-over study. J Clin Monit Comput. 2024 Feb;38(1):31-36. doi: 10.1007/s10877-023-01048-8. Epub 2023 Jul 7.

Reference Type DERIVED
PMID: 37418060 (View on PubMed)

Other Identifiers

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05112022

Identifier Type: -

Identifier Source: org_study_id

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