Trials / Completed
CompletedNCT04119089
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
- Phase
- —
- Study type
- Observational
- Enrollment
- 65 (actual)
- Sponsor
- Hospices Civils de Lyon · Academic / Other
- Sex
- All
- Age
- 37 Weeks – 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Gastric 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. |
Timeline
- Start date
- 2020-05-30
- Primary completion
- 2021-12-18
- Completion
- 2021-12-18
- First posted
- 2019-10-08
- Last updated
- 2022-01-25
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT04119089. Inclusion in this directory is not an endorsement.