Insertion of a Nasogastric TubeSNG echoNCT02866123
Verification of Correct Positioning of a Gastric Tube by Ultrasonography
A study testing ultrasonography and pulmonary radiography in people with Insertion of a Nasogastric Tube and Intubated Patient, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insertion of a Nasogastric Tube, Intubated Patient, Patients Hospitalized in the Surgery Intensive Care Unit
- What is being tested?
- ultrasonography and pulmonary radiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Adults under guardianship, patients under 18 years of age
- Patients without national health insurance cover
- Pregnant women
- Wound or dressing preventing gastric ultrasonography (laparotomy is not an exclusion criterion if the dressing does not prevent ultrasonography being performed)
- result of the radiographic verification seen before the gastric ultrasonography is done
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study to Evaluate Ultrasound Verification of the Correct Position of Gastric Tubes in Intensive Care
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.
- Conditions
- Insertion of a Nasogastric Tube, Intubated Patient, Patients Hospitalized in the Surgery Intensive Care Unit
- Being tested
- ultrasonography, pulmonary radiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasonographyOther
pulmonary radiographyRadiation
| Study group | Role | What they receive |
|---|---|---|
| patient with insertion of an NGT | Experimental | Not described Receives: Other: ultrasonography; Radiation: pulmonary radiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of ultrasonography examinations validating the correct insertion of a nasogastric tube (NGT)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study startJan 2015
- Primary completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insertion of a Nasogastric TubeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02866123
- Sponsor's protocol ID
- Couteau-Girard 2014
- Acronym
- SNG echo
- Status last verified
- Jul 2016
- First submitted
- 4 Aug 2016
- Last updated
- 15 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study to Evaluate Ultrasound Verification of the Correct Position of Gastric Tubes in Intensive Care
- ClinicalTrials.gov ID
- NCT02866123
- Acronym / sponsor ID
- SNG echo / Couteau-Girard 2014
- Conditions
- Insertion of a Nasogastric Tube, Intubated Patient, Patients Hospitalized in the Surgery Intensive Care Unit
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- May 2015 (actual)
- First posted
- 15 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient with insertion of an NGT | Experimental | Other: ultrasonography, Radiation: pulmonary radiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- Adults under guardianship, patients under 18 years of age
- Patients without national health insurance cover
- Pregnant women
- Wound or dressing preventing gastric ultrasonography (laparotomy is not an exclusion criterion if the dressing does not prevent ultrasonography being performed)
- result of the radiographic verification seen before the gastric ultrasonography is done
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasonography | Other | patient with insertion of an NGT |
| pulmonary radiography | Radiation | patient with insertion of an NGT |
Primary outcome
Number of ultrasonography examinations validating the correct insertion of a nasogastric tube (NGT)
Time frame: Day 1
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasonography and pulmonary radiography in people with Insertion of a Nasogastric Tube and Intubated Patient, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of ultrasonography examinations validating the correct insertion of a nasogastric tube (NGT) (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2016.