Effect of Semi-sitting Position on Mask Ventilation
1 other identifier
interventional
38
1 country
1
Brief Summary
We compare the effect on semi-sitting position on mask ventilation in anesthetized and paralyzed obese patients
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 Mar 2020
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
June 20, 2019
CompletedFirst Posted
Study publicly available on registry
June 24, 2019
CompletedStudy Start
First participant enrolled
March 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 8, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 8, 2020
CompletedJune 11, 2020
June 1, 2020
3 months
June 20, 2019
June 8, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Expiratory tidal volume
Expiratory tidal volume is assessed during mask ventilation in the supine and semi-sitting positions.
1 minute after the induction of anesthesia
Secondary Outcomes (3)
Minute ventilation during mask ventilation in the supine and semi-sitting positions
1 minute after anesthesia induction
The incidence of inadequate mask ventilation or dead space ventilation.
during mask ventilation
Peak inspiratory pressure
during mask ventilation
Study Arms (2)
Supine position
ACTIVE COMPARATORAfter the induction of anesthesia, mask ventilation is performed in the supine position.
Semi-sitting position
EXPERIMENTALAfter the induction of anesthesia, mask ventilation is performed in the semi-sitting position.
Interventions
After the induction of anesthesia, mask ventilation is performed in the supine and semi-sitting position in a cross-over, randomized order.
Eligibility Criteria
You may qualify if:
- Obese patients undergoing general anesthesia
You may not qualify if:
- diseases or structural abnormalities in the upper airway
- those who were at risk of aspiration
- cardiovascular or respiratory diseases
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
SMG-SNU Boramae Medical Center
Seoul, South Korea
Related Publications (1)
Chang JE, Seol T, Hwang JY. Body position and the effectiveness of mask ventilation in anaesthetised paralysed obese patients: A randomised cross-over study. Eur J Anaesthesiol. 2021 Aug 1;38(8):825-830. doi: 10.1097/EJA.0000000000001473.
PMID: 33600105DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
June 20, 2019
First Posted
June 24, 2019
Study Start
March 9, 2020
Primary Completion
June 8, 2020
Study Completion
June 8, 2020
Last Updated
June 11, 2020
Record last verified: 2020-06