Gastric Ultrasound for Surgery Patients

Overseen By Laura M Chiang, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dartmouth-Hitchcock Medical Center

Disqualifiers: Gastrointestinal problems, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 16 months

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of different fasting protocols before surgery using gastric ultrasound, a non-invasive imaging technique. The researchers will measure the remaining stomach contents in critically ill patients to determine the better fasting approach. Participants will either follow the standard no-food protocol from midnight or a more flexible feeding schedule until right before surgery. Ideal candidates are ICU patients with a breathing tube already in place who require general anesthesia for a procedure. As an unphased trial, this study allows patients to contribute to important research that could enhance pre-surgery fasting protocols.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that gastric ultrasound is safe for surgery patients?

Research has shown that gastric ultrasound is a safe tool for surgery patients. Studies have found it helps doctors check the stomach's contents without invasive procedures. This allows them to determine if a patient has food in their stomach, helping to prevent issues like aspiration (when food or liquid accidentally enters the lungs).

The procedure is non-invasive, involving no cutting or entering the body. No reports of serious side effects have emerged from using gastric ultrasound. Patients generally tolerate it well, and it can enhance safety by aiding doctors in making better pre-surgery decisions.

In summary, gastric ultrasound is a safe method for checking stomach contents in surgery patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative protocols for managing pre-surgery fasting, aiming to improve patient outcomes. Traditional protocols require patients to fast from midnight before surgery to reduce the risk of aspiration. This trial compares the standard NPO (nil per os) protocol with a liberal feeding protocol, where patients are fed until they are called to the operating room, using a gastric ultrasound to ensure stomach contents are minimal. This approach could enhance patient comfort and nutrition without increasing surgical risks, offering a potentially transformative shift in preoperative care.

What evidence suggests that gastric ultrasound is effective for quantifying gastric residual volumes in critically ill patients?

This trial will compare two protocols for surgery patients: the Standard ASA NPO Protocol and the Liberal Feeding Protocol. Research has shown that using an ultrasound on the stomach effectively checks its contents before surgery. Studies have found that it quickly and accurately assesses the amount of food or liquid present. This information helps doctors determine if patients might face issues like aspiration. The ultrasound is particularly effective at identifying patients who haven't fully digested their last meal. Overall, using a stomach ultrasound reliably enhances surgical safety by assessing stomach contents. ^{6 7 8 9 10}

Who Is on the Research Team?

Laura M Chiang, MD

Principal Investigator

Dartmouth-Hitchcock Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 in the ICU who need general anesthesia or sedation and already have a cuffed breathing tube in place. It's not for those with upper GI tract issues, history of gastric perforation, without a proper breathing tube, or women past their first trimester of pregnancy.

Inclusion Criteria

You are 18 years old or older, in the intensive care unit, and need to be put to sleep or sedated for a procedure with a breathing tube already in place.

Exclusion Criteria

You have a known upper stomach problem that could make it hard to measure how much is in your stomach.

You have a history of a hole in your stomach.

You do not already have a special breathing tube in place.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo gastric ultrasound to quantify gastric residual volumes and compare NPO protocols

16 months

Follow-up

Participants are monitored for peri-operative aspiration events and other outcomes

4 months

What Are the Treatments Tested in This Trial?

Interventions

• Gastric Ultrasound

Trial Overview

The study uses gastric ultrasound on ICU patients to measure how much stomach content they have. This helps check if 'nothing by mouth' (NPO) guidelines before procedures are effective at different times.

How Is the Trial Designed?

Group I: Standard ASA NPO Protocol Experimental Treatment 1 Intervention

Patients will be made NPO at midnight prior to date of surgery.

Group II: Liberal Feeding Protocol Experimental Treatment 1 Intervention

Patients will be fed enterally up until call to OR at which time their stomachs will be decompressed with a pre-existing gastric tube.

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials

548

Recruited

2,545,000+

Published Research Related to This Trial

Point-of-care ultrasound (POCUS) can be a valuable tool for assessing gastric contents to evaluate aspiration risk and improve anesthetic management in both pediatric and adult patients, including special populations like obstetric and obese individuals.

The review highlights the need for further research on the diagnostic accuracy of gastric POCUS and its effects on patient outcomes and healthcare costs, suggesting that it could enhance clinical practices and educational programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Point-of-care gastric ultrasound and aspiration risk assessment: a narrative review. Perlas, A., Arzola, C., Van de Putte, P.[2019]

In a study of 116 children aged 2 to 17 years, 69% were found to have a 'full stomach' (defined as having solid contents or more than 1.2 mL/kg of liquid) before procedural sedation, despite a median fasting time of 5.8 hours.

Each additional hour of fasting slightly reduced the odds of having a full stomach, but fasting time alone was not a reliable predictor of gastric contents, suggesting that gastric point-of-care ultrasound (POCUS) could be a valuable tool for assessing risk before sedation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Full Stomach" Despite the Wait: Point-of-care Gastric Ultrasound at the Time of Procedural Sedation in the Pediatric Emergency Department. Leviter, J., Steele, DW., Constantine, E., et al.[2020]

Point of care ultrasonography (POCUS) is a valuable tool for physicians, allowing for rapid assessment of specific abnormalities that can significantly influence diagnostic and treatment decisions.

POCUS serves as an important complement to physical examinations, particularly in acute situations where multiple organ systems may be affected.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[POCUS is a great asset to general practice]. Bauer, MP., Bosch, FH.[2021]

Point-of-care ultrasonography (POCUS) is increasingly recognized as a safe and effective tool in Pediatric Emergency Departments (PEDs) for diagnosing conditions like pneumonia and guiding procedures such as vascular access and fluid drainage.

Despite its established use in adult emergency medicine, POCUS is still underutilized in pediatrics, highlighting the need for pediatric emergency physicians to become more familiar with this technology to enhance patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Point of care ultrasonography in the pediatric emergency department. Le Coz, J., Orlandini, S., Titomanlio, L., et al.[2018]

Point of Care Ultrasound (POCUS) is a noninvasive and radiation-free imaging technique that allows clinicians to quickly assess patients at the bedside, enhancing initial evaluations.

POCUS is particularly effective in emergency and intensive care settings, leading to earlier and more accurate diagnoses for conditions like shock, renal failure, and dyspnoea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Lung Ultrasound in Acute Medicine. Parulekar, P., Harris, T., Jarman, R.[2020]

Gastric ultrasound (US) is an emerging tool in point-of-care ultrasound (POCUS) that allows for direct measurement of a patient's gastric content, which can enhance clinical decision-making, especially in anesthesia.

The review highlights the historical development and current applications of gastric US, suggesting its potential for use in emergency departments to improve patient assessment and management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Point-of-Care Ultrasound to Assess Gastric Content. Moake, MM., Jackson, BF., Presley, BC.[2021]

Point-of-Care Ultrasound (POCUS) demonstrated high overall sensitivity (81%) and specificity (87%) for diagnosing acute appendicitis in the emergency department, based on a systematic review of 21 studies.

Despite the promising diagnostic accuracy indicated by a high area under the curve (0.9249), there was significant heterogeneity in the sensitivity and specificity results across the studies, suggesting variability in ultrasound performance in different settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of ultrasound for the diagnosis of acute appendicitis in the emergency department: A systematic review. Cho, SU., Oh, SK.[2023]

Point-of-care ultrasound (POCUS) allows for immediate imaging during physical examinations, providing instant clinical information to healthcare providers.

Using POCUS has been shown to accelerate the diagnostic process and enhance both diagnostic accuracy and the appropriateness of treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correspondence - Evaluation of a basic point-of-care ultrasound course for residents in internal medicine. Blans, MJ., Kok, B., Gils-Poppe, HJV., et al.[2022]

Gastric point-of-care ultrasound (POCUS) is a reliable and effective tool in pediatric settings, particularly for assessing gastric emptying and volume, diagnosing foreign body ingestion, and confirming nasogastric tube placement, based on a review of 70 studies.

The use of gastric POCUS can optimize clinical management in acute and critically ill children by providing rapid and accurate assessments, potentially reducing the need for more invasive procedures and minimizing radiation exposure, although further research is needed in critically ill pediatric populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gastric Point-of-Care Ultrasound in Acutely and Critically Ill Children (POCUS-ped): A Scoping Review. Valla, FV., Tume, LN., Jotterand Chaparro, C., et al.[2023]

Point-of-care ultrasonography (POCUS) of the gastric antrum is a practical and effective method for assessing the risk of aspiration in patients undergoing upper gastrointestinal endoscopy, with qualitative scans identifying unsafe gastric contents in 5% of cases despite adequate fasting.

The study involved 83 patients and found only a moderate correlation between measured gastric volumes and traditional nomogram or formula-based assessments, suggesting that while POCUS is useful, it may not fully replace these methods for estimating gastric residual volume.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Utility of Routine Point-of-Care Gastric Ultrasonography in Patients Undergoing Upper Gastrointestinal Endoscopy Procedures: A Prospective Cohort Study. Kalagara, H., Sondekoppam, RV., Ahmed, AM., et al.[2023]

Point-of-care ultrasound (POCUS) performed by a gastroenterologist after 200 supervised scans is a safe and effective method for assessing Crohn's disease activity, extent, and complications, showing high sensitivity and specificity compared to magnetic resonance enterography (MRE) and ileo-colonoscopy.

The accuracy of POCUS is supported by moderate agreement with MRE and ileo-colonoscopy, indicating it can be a reliable imaging tool in clinical decision-making for Crohn's disease management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of point-of-care intestinal ultrasound for Crohn's disease. Wright, EK., Wang, I., Wong, D., et al.[2022]

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