Gastric Volume in Paralyzed Obese Patients After High-flo... | NCT06216912

Studies
Gastric Volume in Paralyzed Obese Patients After High-flow Nasal Oxygen Therapy

NCT06216912

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

May 30, 2024Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Undefined

Interventions

Not provided

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

Jan 2024

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

Jan 10, 2024Actual

Primary Completion Date

Jan 1, 2025Estimated

Completion Date

Jan 31, 2025Estimated

First Submitted Date

Jan 3, 2024

First Submission Date that Met QC Criteria

Jan 17, 2024

First Posted Date

Jan 22, 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

May 28, 2024

Last Update Posted Date

May 30, 2024Actual

Name	Class
SMG-SNU Boramae Medical Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Preoperative preoxygenation is performed using High-flow nasal oxygen therapy, and the gastric volume before and after High-flow nasal oxygen therapy is measured by ultrasound and compared in obese patients undergoing surgery under general anesthesia.

Detailed Description

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
gastric volume measured by gastric ultrasound	gastric volume measured by gastric ultrasound	immediately before HFNOT, immediately after HFNOT, immediately after tracheal intubation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients with a BMI of 30 kg/m2 or more, undergoing surgery under general anesthesia

Exclusion Criteria:

Nasotracheal intubation
History of a surgery or anatomical anomaly in the head and neck
History of Inability to breathe through nose
History of difficult airway
Severe cardiac or respiratory disease
Gastric reflux disease, diabetes, pregnancy
Previous gastric surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Obese patients undergoing surgery under general anesthesia

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tae Kyong Kim	Contact	82-2-870-2519		ktkktk@gmail.com

Overall Officials

Not provided

Locations

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