Effect of Paratracheal Pressure on Mask Ventilation
1 other identifier
interventional
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2022
CompletedFirst Posted
Study publicly available on registry
May 24, 2022
CompletedStudy Start
First participant enrolled
July 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 20, 2022
CompletedNovember 1, 2022
October 1, 2022
4 months
May 12, 2022
October 31, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Expiratory tidal volume
Volume controlled mechanical ventilation is delivered during mask ventilation. Expiratory tidal volumes on the monitor screen are recorded during mask ventilation
For 2 min of mask ventilation after the induction of anesthesia
Secondary Outcomes (3)
Peak inspiratory pressure
For 2 min of mask ventilation after the induction of anesthesia
Inadequate tidal volume
For 2 min of mask ventilation after the induction of anesthesia
Incidence of hypoxia
For 2 min of mask ventilation after the induction of anesthesia
Study Arms (2)
Paratracheal pressure
EXPERIMENTALAfter the induction of anesthesia, paratracheal pressure is applied during mask ventilation.
No pressure
ACTIVE COMPARATORAfter the induction of anesthesia, no pressure is applied during mask ventilation.
Interventions
Mask ventilation is performed under paratracheal pressure or no pressure in a randomized, crossover manner.
Eligibility Criteria
You may qualify if:
- Adult patients with a body mass index ≥ 30 kg.m-2 undergoing general anesthesia for elective surgery
You may not qualify if:
- Structural abnormalities or diseases in the face, neck, upper airway, or esophagus
- Increased risk of aspiration (pregnancy)
- Carotid artery stenosis, cerebrovascular disease
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
Related Publications (1)
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.
PMID: 37418060DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 12, 2022
First Posted
May 24, 2022
Study Start
July 4, 2022
Primary Completion
October 20, 2022
Study Completion
October 20, 2022
Last Updated
November 1, 2022
Record last verified: 2022-10