NCT06216912

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2024

Completed
7 days until next milestone

Study Start

First participant enrolled

January 10, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 22, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

May 30, 2024

Status Verified

January 1, 2024

Enrollment Period

12 months

First QC Date

January 3, 2024

Last Update Submit

May 28, 2024

Conditions

Undefined

Outcome Measures

Primary Outcomes (1)

  • gastric volume measured by gastric ultrasound

    gastric volume measured by gastric ultrasound

    immediately before HFNOT, immediately after HFNOT, immediately after tracheal intubation

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Obese patients undergoing surgery under general anesthesia

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SMG - SNU Boramae Medical Center

Seoul, 07061, South Korea

RECRUITING

Central Study Contacts

Tae Kyong Kim

CONTACT

82-2-870-2519ktkktk@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2024

First Posted

January 22, 2024

Study Start

January 10, 2024

Primary Completion

January 1, 2025

Study Completion

January 31, 2025

Last Updated

May 30, 2024

Record last verified: 2024-01

Locations

KR(1)