Incidence of Compliance to the ASA Preoperative Fasting G... | NCT04664751

Studies
Incidence of Compliance to the ASA Preoperative Fasting Guidelines in Elective Surgery

NCT04664751

Sponsor

Mahidol University

Status

Completed

Last Update Posted

Jan 10, 2023Actual

Enrollment

309Actual

Phase

Not provided

Conditions

Compliance, Treatment

Interventions

Nil-per-Oral

Countries

Thailand

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 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 26, 2020Actual

Primary Completion Date

May 1, 2022Actual

Completion Date

May 1, 2022Actual

First Submitted Date

Nov 25, 2020

First Submission Date that Met QC Criteria

Dec 7, 2020

First Posted Date

Dec 11, 2020Actual

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 9, 2023

Last Update Posted Date

Jan 10, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Patients scheduled for elective surgery with general anesthesia, regional anesthesia, or procedural sedation and analgesia will be interviewed about the last time having

clear liquid drink
light meal
regular meal

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

309Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients scheduled for general surgery with anesthesia		Patients scheduled for general surgery with anesthesia, receiving Nil-per-Oral order.	Other: Nil-per-Oral

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nil-per-Oral	Other	NPO details	Patients scheduled for general surgery with anesthesia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
compliance to NPO guideline	definition of compliance include complete order of NPO for regular diet for 8 hours and soft diet for 6 hours and clear liquid for 2 hours.	8 hour

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Scheduled for elective surgery requiring general anesthesia, regional anesthesia, or procedural sedation and analgesia.

Exclusion Criteria:

Patients with the order of NPO after midnight.
Patients with pregnancy

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

Patients scheduled for elective surgery requiring general anesthesia, regional anesthesia, or procedural sedation and analgesia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sirilak Suksompong, MD	Mahidol University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine Siriraj Hospital, Mahidol University		Bangkok		10700	Thailand

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
D010349	Patient Compliance

Ancestor Terms

ID	Term
D010342	Patient Acceptance of Health Care
D000074822	Treatment Adherence and Compliance
D015438	Health Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided