Gastric Volume Following Sips of Water Intake | NCT06210906

Studies
Gastric Volume Following Sips of Water Intake

NCT06210906

Sponsor

SMG-SNU Boramae Medical Center

Status

Unknown status

Last Update Posted

Feb 14, 2024Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Stomach Filling

Interventions

Assessment of gastric volume

Countries

Not provided

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

Feb 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 26, 2024Estimated

Primary Completion Date

Feb 21, 2025Estimated

Completion Date

Feb 21, 2025Estimated

First Submitted Date

Jan 8, 2024

First Submission Date that Met QC Criteria

Jan 8, 2024

First Posted Date

Jan 18, 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

Feb 13, 2024

Last Update Posted Date

Feb 14, 2024Actual

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

We aim to observe whether drinking of sips of water within 1 hour before surgery significantly affects the gastric volume.

Detailed Description

Not provided

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

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sips of water		Patients taking sips of water within 1 hour in preoperative fasting	Other: Assessment of gastric volume
No sips of water		Patients not taking sips of water within 1 hour in preoperative fasting	Other: Assessment of gastric volume

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Assessment of gastric volume	Other	Gastric volume is assessed using ultrasound.	No sips of water Sips of water

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Gastric volume	Gastric volume is assessed using ultrasound in the supine and right lateral decubitus position.	Immediately before induction of anesthesia

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients over 65 years old undergoing elective surgery under general anesthesia

Exclusion Criteria:

History of gastric surgery
Anatomical anomaly, diseases, or mass in the stomach

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Patients over 65 years old undergoing elective surgery under general anesthesia

Sampling Method

Non-Probability Sample