High-flow Nasal Oxygenation During Preoxygenation and Atelectasis
The Effect of High-flow Nasal Cannula Applied During Preoxygenation for Prevention of Atelectasis in Patients With Obesity Undergoing General Anesthesia: A Randomized Controlled Trial
1 other identifier
interventional
92
1 country
1
Brief Summary
Atelectasis after induction of general anesthesia is common even in healthy patients and is clinically problematic, especially in obese patients. We aim to investigate whether preoxygenation with high-flow nasal oxygen during anesthesia induction reduces atelectasis in obese patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2023
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
September 19, 2023
CompletedStudy Start
First participant enrolled
October 10, 2023
CompletedFirst Posted
Study publicly available on registry
January 12, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 10, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 10, 2024
CompletedJanuary 12, 2024
September 1, 2023
1 year
September 19, 2023
January 3, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Lung ultrasound score
modified LUSS
Immediately after anesthesia induction
Secondary Outcomes (9)
Incidence of atelectasis
Immediately after anesthesia induction
PaO2 to FiO2 ratio and PaCO2
Immediately after anesthesia induction
Hemodynamic variables
During anesthesia induction
Patient Satisfaction Score
During preoxygenation
Lung ultrasound score
In the PACU after surgery
- +4 more secondary outcomes
Study Arms (2)
facemask
ACTIVE COMPARATORpreoxygenation using a conventional facemask
high-flow nasal oxygen
EXPERIMENTALpreoxygenation using high-flow nasal cannula oxygen
Interventions
preoxygenation using high-flow nasal oxygen, FiO2 1.0, 40 L/min, 3 min
Eligibility Criteria
You may qualify if:
- Adults patients undergoinig surgery under general anesthesia with a BMI of 30 kg/m2 or greater who have given informed consent
You may not qualify if:
- surgery time less than 2 hours
- Nasotracheal intubation
- Severe cardiac or respiratory disease
- History of difficult airway
- History of a surgery or anatomical anomaly in the head and neck
- History of Inability to breathe through nose
- Gastric reflux disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seoul National University Hospitallead
- SMG-SNU Boramae Medical Centercollaborator
Study Sites (1)
SMG - SNU Boramae Medical Center
Seoul, 07061, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
TAE KYONG KIM
SMG-SNU Boramae Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2023
First Posted
January 12, 2024
Study Start
October 10, 2023
Primary Completion
October 10, 2024
Study Completion
October 10, 2024
Last Updated
January 12, 2024
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share