NCT07656649 Effect of a Liberal Fasting Regime (Sip-til-Send) on Preoperative Gastric Volume Measured Using Point of Care Ultrasound
| NCT ID | NCT07656649 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Haukeland University Hospital |
| Condition | Fasting Status |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2026-06-02 |
| Primary Completion | 2027-05-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2026-06-02 with a primary completion date of 2027-05-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Pulmonary aspiration of gastric contents during surgery is a rare but potentially catastrophic event. Current guidelines recommend that patients should fast for six hours for solid food and two hours for clear liquids. Despite this, many patients fast considerably longer than two hours for clear liquids, often as a result of logistical challenges. In response to this, the Sip-to-Send concept was developed where patients are permitted to drink small amounts of clear liquid (170-200 ml per hour) until they are called to the operating department. The introduction of Sip-to-Send has been well received by patients and has been associated with increased patient satisfaction. For planned general anaesthesia in the operating department, the incidence of pulmonary aspiration is estimated at approximately 1 per 4,500 anaesthetics. Because of this low incidence, it is in practice unrealistic to design studies using aspiration as the primary endpoint to demonstrate non-inferiority of new fasting regimens. For example, a study with a non-inferiority margin of 20%, power of 90% and a one-sided α of 0.025, based on an incidence of 1 per 4,500, would require approximately 2.6 million patients in each study arm. Gastric ultrasound represents a rapid, non-invasive technique for estimating gastric volume by measuring the cross-sectional area of the antrum and subsequently calculating volume. Several studies have shown that cross-sectional area correlates reliably with gastric volume, with good inter- and intra-observer reliability. Sip-to-Send has been established practice at the Day Surgery Department at Haukeland since October 2023. The purpose of this study is to investigate whether there is a clinically relevant change in gastric volume as a result of this liberal fasting regimen.
Eligibility Criteria
Inclusion Criteria: * Able to give written consent * Adult patient (\> 18 years of age) * Planned general anaesthesia or deep sedation * Fasted for at least six hours for food and two hours for clear fluids upon arrival * Expected to wait at least one hour before surgery Exclusion Criteria: * Unable to give written consent * Active gastrointestinal obstruction * Pregnancy * Ongoing opioid use * Previous stomach surgery - gastric banding / Roux-en-Y / sleeve gastrectomy * Use of GLP-1 agonist (Wegovy) * Type 1 or 2 diabetes
Contact & Investigator
Øyvind S Svendsen, PhD
STUDY DIRECTOR
Haukeland University Hospital
Frequently Asked Questions
Who can join the NCT07656649 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Fasting Status. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07656649 currently recruiting?
Yes, NCT07656649 is actively recruiting participants. Contact the research team at jonathan.douglas.mathers@helse-bergen.no for enrollment information.
Where is the NCT07656649 trial being conducted?
This trial is being conducted at Bergen, Norway.
Who is sponsoring the NCT07656649 clinical trial?
NCT07656649 is sponsored by Haukeland University Hospital. The principal investigator is Øyvind S Svendsen, PhD at Haukeland University Hospital. The trial plans to enroll 120 participants.