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Gastric Ultrasound to Monitor Gastric Residual Volume

Reliability of Gastric Suctioning Compared to Gastric Ultrasound for Residual Gastric Volume Monitoring in Intensive Care Unit Pediatric Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04119089
Acronym
GASTRIPED
Enrollment
65
Registered
2019-10-08
Start date
2020-05-30
Completion date
2021-12-18
Last updated
2022-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Enteral Feeding Intolerance, Mechanical Ventilation Complication

Brief summary

It is currently recommended to start enteral nutrition early in intensive care unit children receiving invasive or non-invasive mechanical ventilation. Gastrointestinal intolerance is the main complication related to early enteral feeding in intensive care unit patients, characterized by gastroparesis with delayed gastric emptying that may lead to regurgitations, vomiting, pulmonary aspiration, and potentially increased risk of ventilator-associated pneumonia (VAP). Residual gastric volume (RGV) measurement had been recommended to monitor the tolerance to enteral nutrition in mechanically ventilated patients receiving early enteral feeding. Nevertheless, several studies have challenged the usefulness of such RGV monitoring, showing that it led to reduced caloric intake without any benefits in terms of reducing the occurrence of vomiting and the incidence of VAP. This lack of relationship between RGV monitored using gastric suctioning and the occurrence of regurgitation, aspiration and pneumonia may reflect the inaccuracy of the aspiration method used for the measurement of the RGV, as it has been reported in adult patients. Gastric ultrasonography is a non-invasive and easy-to-use tool allowing accurate preoperative assessment of gastric contents, based on both qualitative examination of the gastric antrum and calculation of gastric content volume. Ultrasound examination of the antrum could therefore constitute an alternative to gastric suctioning for the monitoring of RGV in intensive care unit patients. This prospective study aims to assess the reliability of the RGV monitoring based on gastric suctioning compared to ultrasound technique. Secondary endpoint is to assess whether increased gastric volume, aspirated or calculated by ultrasound, is an independent risk factor of regurgitation and / or vomiting.

Interventions

OTHERGastric ultrasound

A first gastric ultrasound will be performed in the supine and the right lateral (RLD) decubitus position, allowing a qualitative analysis of the gastric contents (empty, liquid, solid, solid-liquid). The antral area will also be measured in both positions. The volume of gastric fluid content will be calculated according to the following formula: volume (ml) = -7,8 + (0,035 x antral area in RLD (mm²)) + 0,127 x age (month). This examination will be immediately followed by the aspiration of gastric contents through the nasogastric tube used for enteral feeding, into 50-ml syringes, by a nurse blinded to the result of the first ultrasound examination. A second antral ultrasound examination will then be performed, by the same investigator blinded to the volume aspirated. The occurrence of regurgitation and / or vomiting occurring within the 12 hours before and after the examination will be recorded.

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
37 Weeks to 18 Years
Healthy volunteers
No

Inclusion criteria

* Children hospitalized in intensive care unit, requiring invasive or non-invasive mechanical ventilation for a foreseeable duration \> 48 hours. * Enteral nutrition that has been started for more than 48 hours and less than 7 days. * Age between 37 weeks of post conceptual age and 18 years. * Parental consent or consent by the person having parental authority.

Exclusion criteria

* Abdominal surgery ≤ 1 year * History of esophageal, gastric, duodenal, or pancreatic surgery * Enteral nutrition via jejunostomy or gastrostomy. * Any situation contraindicating the mobilization of the child in the right lateral decubitus position (uncontrolled hemodynamic instability, unstable neurological injury ...)

Design outcomes

Primary

MeasureTime frameDescription
Percentage of patients with an empty stomach after aspiration of gastric contents performed for the residual gastric volume monitoring.Maximum 1 day (Second gastric ultrasound, performed once aspiration of gastric contents has been achieved)Empty stomach is defined as the lack of any gastric content when performing the second gastric ultrasound, after aspiration of gastric contents.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026