High-flow Nasal Oxygenation During Preoxygenation and Ate... | NCT06205212

Studies
High-flow Nasal Oxygenation During Preoxygenation and Atelectasis

NCT06205212

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Jan 12, 2024Actual

Enrollment

92Estimated

Phase

Not Applicable

Conditions

Anesthesia, General
Pulmonary Atelectasis

Interventions

high-flow nasal oxygen
facemask

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 10, 2023Actual

Primary Completion Date

Oct 10, 2024Estimated

Completion Date

Oct 10, 2024Estimated

First Submitted Date

Sep 19, 2023

First Submission Date that Met QC Criteria

Jan 3, 2024

First Posted Date

Jan 12, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 3, 2024

Last Update Posted Date

Jan 12, 2024Actual

Name	Class
SMG-SNU Boramae Medical Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

92Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
facemask	Active Comparator	preoxygenation using a conventional facemask	Other: facemask
high-flow nasal oxygen	Experimental	preoxygenation using high-flow nasal cannula oxygen	Other: high-flow nasal oxygen

Interventions

Name	Type	Description	Arm Group Labels	Other Names
high-flow nasal oxygen	Other	preoxygenation using high-flow nasal oxygen, FiO2 1.0, 40 L/min, 3 min	high-flow nasal oxygen

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Lung ultrasound score	modified LUSS	Immediately after anesthesia induction

Secondary Outcomes

Measure	Description	Time Frame
Incidence of atelectasis		Immediately after anesthesia induction
PaO2 to FiO2 ratio and PaCO2		Immediately after anesthesia induction
Hemodynamic variables

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults patients undergoinig surgery under general anesthesia with a BMI of 30 kg/m2 or greater who have given informed consent

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
TAE KYONG KIM	Contact	82-2-870-2519		ktkktk@gmail.com

Overall Officials

Name	Affiliation	Role
TAE KYONG KIM	SMG-SNU Boramae Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SMG - SNU Boramae Medical Center	Recruiting	Seoul		07061	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001261	Pulmonary Atelectasis

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided