NCT03205592

Brief Summary

This prospective observational study aims to assess whether ultrasound assessment of gastric content may be useful for the monitoring of the gastric residual content in critically ill patients

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2017

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 2, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

July 3, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2018

Completed
Last Updated

May 7, 2018

Status Verified

May 1, 2018

Enrollment Period

10 months

First QC Date

June 28, 2017

Last Update Submit

May 4, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • change in antral cross sectional area measured by ultrasonography after suctioning gastric volume

    Ultrasound measurement of antral area and qualitative assessment

    prior to and immediately after suctioning of gastric content volume through a gastric tube

  • Change in antral area after administration of prokinetic drug

    If aspirated gastric content volume was \> 250 ml, only 250 ml will be reinjected into the stomach and a prokientic drug will be administered (current protocol in our units). Antral area will be measured prior to and 90 min after the start of the infusion

    Ultrasound assessment of gastric content after reinjection of suctioned gastric content and 1h30 later (1 h after the end of the infusion of prokinetic drug)

Interventions

Ultrasound assessment of gastric content will be performed : prior to suction of gastric content through a gastric tube (method to assess the residual gastric content volume), after this suctioning of gastric content, then after reinjection of the content suctioned into the stomach (max 250 ml) and 1h30 later

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Critically ill patients hospitalized in 3 critical care units (Groupement hospitalier Sud Lyon, Saint Etienne, Marseille)

You may qualify if:

  • Critically ill patients under mechanical ventilation and enteral feeding through a gastric tube since \>48 h

You may not qualify if:

  • Digestive hemorrhage Contra-indication to prokinetic drugs Enteral feeding through jejunostomy or gastrostomy Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hôpital Nord

Marseille, 13015, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69310, France

Location

CHU Saint Etienne

Saint-Etienne, 42000, France

Location

Related Publications (1)

  • Bouvet L, Zieleskiewicz L, Loubradou E, Alain A, Morel J, Argaud L, Chassard D, Leone M, Allaouchiche B; AzuRea CAR'Echo collaborative networks. Reliability of gastric suctioning compared with ultrasound assessment of residual gastric volume: a prospective multicentre cohort study. Anaesthesia. 2020 Mar;75(3):323-330. doi: 10.1111/anae.14915. Epub 2019 Dec 4.

Study Officials

  • Lionel BOUVET, MD PhD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 28, 2017

First Posted

July 2, 2017

Study Start

July 3, 2017

Primary Completion

May 4, 2018

Study Completion

May 4, 2018

Last Updated

May 7, 2018

Record last verified: 2018-05

Locations