Gastric Content After 6 vs 4 Hours of Preoperative Fasting in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-23

Study Completion Date

2025-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary objective of the study is to compare the risk of increased stomach contents after tube feeding (Enteral feeding) 6 and 4 hours before anesthesia using antrum measured by ultrasound.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Ultrasound Assessment of Preoperative Gastric Volume in Children

NCT03017066

Fasting

COMPLETED NA

Estimation of Preoperative Gastric Volume Using Ultrasound

NCT03155776

Fasting

COMPLETED

Gastric Assessment of Pediatric Patients Undergoing Surgery

NCT05674643

Fasting Delayed Gastric Emptying Aspiration Pneumonia +1 more

RECRUITING

Gastric Emptying Times of Normal and Obese Children After Preoperative Clear Fluid Drinking: An Ultrasound Study

NCT05244902

Gastric Emptying Time

COMPLETED NA

Examination of Gastric Emptying in Children

NCT01133691

Gastric Emptying

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Children must fast for a certain period of time before anesthesia and surgery to reduce the risk of food residues being vomited up and ending up in the trachea (so-called aspiration). But there are disadvantages to fasting for a long time before an operation, for example the blood sugar level can drop and the body can become dehydrated. Small children risk such side effects to a greater degree than adults, and therefore international work is underway to revise the rules for fasting before surgery.

Enteral feeding children are a special risk group because they are usually completely dependent on tube feeding for nutrition and fluid intake.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Aspiration of Gastric Contents

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial.

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Computerized randomization. Randomization outcome distributed via sealed envelopes. Randomization key stored on secure server.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

4H group

Patients parents instructed to stop enteral feeding 4 hours before predicted anesthesia induction

Group Type EXPERIMENTAL

Preoperative fasting instruction

Intervention Type PROCEDURE

Patients parents instructed to stop enteral feeding at a specified time before predicted anesthesia induction

6H group

Patients parents instructed to stop enteral feeding 6 hours before predicted anesthesia induction

Group Type ACTIVE_COMPARATOR

Preoperative fasting instruction

Intervention Type PROCEDURE

Patients parents instructed to stop enteral feeding at a specified time before predicted anesthesia induction

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Preoperative fasting instruction

Patients parents instructed to stop enteral feeding at a specified time before predicted anesthesia induction

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Child on intermittent or continuous enteral nutrition, scheduled for elective procedure requiring general anesthesia

Exclusion Criteria

Moderate to severe gastrointestinal motility disorder Emergency surgery Anatomical risk factor for pulmonary aspiration such as achalasia or bowel obstruction Parents cannot understand study information due to language barrier

Minimum Eligible Age

6 Months

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No