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
ID
Bron
Verkorte titel
Aandoening
NA
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Total gastric fluid volume (quantitatively and qualitatively) in children scheduled for elective surgery after the liberal 6-4-0 regime.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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
Onderzoeksopzet
One-time measurement, directly pre-operatively
Onderzoeksproduct en/of interventie
NA (Observational)
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Age between 0 and 16 years
- Elective surgery
- Followed the fasting guidelines with the 6-4-0 regime
- Informed consent
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
Register | ID |
---|---|
NTR-new | NL9716 |
Ander register | CMO Radboudumc : CMO 2020-6924 |