NCT02866123

Brief Summary

There are several ways to verify the correct positioning of a gastric tube. Radiography is considered the reference method. The use of ultrasonography could diminish the number of radiographies necessary. The hypothesis of this research is that gastric ultrasonography performed during insertion of the tube is a reliable examination to check the correct positioning of gastric tubes in intensive care.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

January 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 15, 2016

Completed
Last Updated

August 15, 2016

Status Verified

July 1, 2016

Enrollment Period

4 months

First QC Date

August 4, 2016

Last Update Submit

August 12, 2016

Conditions

Insertion of a Nasogastric TubeIntubated PatientPatients Hospitalized in the Surgery Intensive Care Unit

Outcome Measures

Primary Outcomes (1)

  • Number of ultrasonography examinations validating the correct insertion of a nasogastric tube (NGT)

    Day 1

Study Arms (1)

patient with insertion of an NGT

EXPERIMENTAL
Other: ultrasonographyRadiation: pulmonary radiography

Interventions

ultrasonographyOTHER
patient with insertion of an NGT
pulmonary radiographyRADIATION
patient with insertion of an NGT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients, or their persons of trust, in cases of coma or sedated patients) who have given informed oral consent
  • All patients hospitalized in the surgery intensive care unit of Dijon CHU, who are intubated and require a gastric tube

You may not qualify if:

  • Adults under guardianship, patients under 18 years of age
  • Patients without national health insurance cover
  • Pregnant women
  • result of the radiographic verification seen before the gastric ultrasonography is done

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21079, France

Location

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2016

First Posted

August 15, 2016

Study Start

January 1, 2015

Primary Completion

May 1, 2015

Last Updated

August 15, 2016

Record last verified: 2016-07

Locations

FR(1)