Bedside Observation by Clinical Ultrasound for Stomach Expansion

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Saint Joseph Saint Luc de Lyon

About this trial

The objective of the BOCUSE study is to demonstrate a relationship between an early ultrasound measurement of the gastric antral area and the subsequent occurrence of poor gastric tolerance.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Predicted mechanical ventilation ≥ 48 hours

Initiation of enteral nutrition via nasogastric or orogastric tube for ≥ 48 hours

Free and informed consent obtained from the patient's relative or legal representative, or inclusion in an emergency situation

Disqualifiers

History of major gastric surgery (bypass, total gastrectomy, biliopancreatic diversion)

Enteral nutrition via nasogastric or orogastric tube > 96 hours

Initiation of enteral nutrition before intubation

Feeding via gastrostomy, jejunostomy, or jejunal tube

Trial design

Design model

Single group

Treatments tested in this trial

  • Gastric ultrasound with measurement of the antral area

    Other intervention

    Gastric ultrasound with measurement of the antral area

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: Monitoring of enteral nutrition intoleranceOther 1 intervention

Trial outcomes

Primary outcomes

1

Enteral nutrition intolerance

Presence of regurgitation and/or vomiting and/or interruption or reduction of enteral nutrition flow rates

Time frame
Within 7 days following the gastric ultrasound

Secondary outcomes

1

Occurrence of VAP

Occurrence of Ventilator Associated Pneumonia

Time frame
From H0 until ICU discharge, up to 3 months
2

Mortality

Mortality at ICU discharge, at day 28, and at 3 months

Time frame
At ICU discharge, at 28 days, and at 3 months
3

Duration of mechanical ventilation

Number of days on mechanical ventilation

Time frame
From H0 until ICU discharge, up to 3 months
4

Number of ventilator-free days

Number of ventilator-free days at day 28 and 3 months

Time frame
Day 28, 3 months

Other outcomes

Sponsors and contacts

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