No registrations found.
ID
Source
Brief title
Health condition
NA
Sponsors and support
Intervention
Outcome measures
Primary outcome
Total gastric fluid volume (quantitatively and qualitatively) in children scheduled for elective surgery after the liberal 6-4-0 regime.
Secondary outcome
- Prevalence of solid contents and/or a calculated gastric fluid volume >1.5 mL/kg
- Actual duration of fluid fasting in daily clinical practice with the 6-4-0 regime
Background summary
Rationale:
The current guidelines for perioperative fasting in paediatric patients recommend 6 h for solids, 4 h for breast milk, and 2 h for clear fluids prior to anaesthesia (6-4-2 regime). In Sweden a more liberal fasting regime has been implemented for more than a decade. Children scheduled for elective procedures requiring anaesthesia are allowed to drink clear fluids until they are called to the operating room (6-4-0) regime. Increased gastric content volume is one of the contributing factors for regurgitation and pulmonary aspiration.
Objective:
Estimate the total gastric volume quantitatively and determine qualitatively gastric contents by gastric ultrasound after the implementation of the liberal 6-4-0 h regime.
Study design:
A prospective observational study.
Study population:
Paediatric patients up to sixteen years of age for elective surgery
Intervention (if applicable): NA
Main study parameters/endpoints:
To assess the total gastric volume quantitatively and qualitatively with paediatric patients after implantation of the liberal (6-4-0) regime for fasting.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
By using a non-invasive instrument and minimizing the duration of the research to a few minutes with every patient we try to minimize the potential risk and burden.
Study objective
Gastric fluid volumes in patients with a 6-4-0 pre-operative fasting regime are comparable to patients with a 6-4-2 pre-operative fasting regime
Study design
One-time measurement, directly pre-operatively
Intervention
NA (Observational)
Inclusion criteria
- Age between 0 and 16 years
- Elective surgery
- Followed the fasting guidelines with the 6-4-0 regime
- Informed consent
Exclusion criteria
- Refusal of parents or legal guardian to participate in the study
- History of upper gastrointestinal disease or surgical procedures of the esophagus or the upper abdomen
- Emergency surgery
- Pre-existing structural abnormality of the upper gastro-intestinal tract
- Decision of the care providers that the ultrasound examination is not in the best interest of the patient at that time
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9716 |
| Other | CMO Radboudumc : CMO 2020-6924 |