Ultrasound for Confirmation of Gastric Tube Placement in Critically Ill Patients Under Invasive Mechanical VentilationNCT04795895
Ultrasound for Confirmation of Gastric Tube Placement in Critically Ill Patients Under Invasive Mechanical Ventilation
A study testing ultrasonography (US) and Standard routine (SR) in people with Ultrasound for Confirmation of Gastric Tube Placement in Critically Ill Patients Under Invasive Mechanical Ventilation, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Introduction: Data using ultrasonography to confirm correct position of the gastric tube is heterogeneous in approach sites, combination exams, and methodology. Aim: Find the best strategy to confirm gastric tube placement to avoid immediate complication. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Ultrasound for Confirmation of Gastric Tube Placement in Critically Ill Patients Under Invasive Mechanical Ventilation
- What is being tested?
- ultrasonography (US) and Standard routine (SR)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2021to 1 Oct 2023
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical indication of nasogastric tube placement
- Age than 20 years old.
Who cannot join
- Facial trauma or head-base fractures
- Esophageal or gastric resection
- Esophageal strictures or alkaline injury
- Open wound in the area to prevent ultrasonography
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound for Confirmation of Gastric Tube Placement in Critically Ill Patients Under Invasive Mechanical Ventilation, a Randomization Trial
Introduction: Data using ultrasonography to confirm correct position of the gastric tube is heterogeneous in approach sites, combination exams, and methodology.
Aim: Find the best strategy to confirm gastric tube placement to avoid immediate complication.
Method: A randomized controlled trial was initiated to compare ultrasonography and standard routine method, using non-inferiority design. The study will be conducted in one medical ICU with 59 beds at a medical center. The primary outcome is the correct rate as comparing with the chest radiography in each group. Total 190 patients is needed with estimated 10% drop-out rate.
- Being tested
- ultrasonography (US), Standard routine (SR)
- Keywords
- Point-of-care ultrasound,ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasonography (US)Diagnostic test
US evaluation was performed after insertion of the tube via subxiphoid approach for tube passing esophagogastric (EG) junction. The tube insertion procedure will be repeated no more than three attempts if no visualization by US.
Standard routine (SR)Diagnostic test
Standard routine (SR)
| Study group | Role | What they receive |
|---|---|---|
| ultrasonography (US) | Experimental | Not described Receives: Diagnostic Test: ultrasonography (US) |
| Standard routine (SR) | Active comparator | Not described Receives: Diagnostic Test: Standard routine (SR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
correct rate as comparing with the chest radiography in each group
Measured: 1 day
Secondary outcomes (1)
procedure time, tube placement confirmation time other than chest radiography method, and additional auscultation method in US group
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start1 Mar 2021
- Primary completion1 Oct 2023
- Study completion1 Oct 2023
Why it stopped: No obvious difference of primary outcome was detected when external reviewing
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultrasound for Confirmation of Gastric Tube Placement in Critically Ill Patients Under Invasive Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ying-Chun Chien, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04795895
- Sponsor's protocol ID
- 201907167RINB
- Status last verified
- Jul 2024
- First submitted
- 10 Mar 2021
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound for Confirmation of Gastric Tube Placement in Critically Ill Patients Under Invasive Mechanical Ventilation, a Randomization Trial
- ClinicalTrials.gov ID
- NCT04795895
- Acronym / sponsor ID
- 201907167RINB
- Keywords
- Point-of-care ultrasound,ultrasound
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No obvious difference of primary outcome was detected when external reviewing
- Enrolment
- 62 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 12 Mar 2021 (actual)
- 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.
Introduction: Data using ultrasonography to confirm correct position of the gastric tube is heterogeneous in approach sites, combination exams, and methodology.
Aim: Find the best strategy to confirm gastric tube placement to avoid immediate complication.
Method: A randomized controlled trial was initiated to compare ultrasonography and standard routine method, using non-inferiority design. The study will be conducted in one medical ICU with 59 beds at a medical center. The primary outcome is the correct rate as comparing with the chest radiography in each group. Total 190 patients is needed with estimated 10% drop-out rate.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ultrasonography (US) | Experimental | Diagnostic Test: ultrasonography (US) |
| Standard routine (SR) | Active comparator | Diagnostic Test: Standard routine (SR) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical indication of nasogastric tube placement
- Age than 20 years old.
Key exclusion criteria (4 listed)
- Facial trauma or head-base fractures
- Esophageal or gastric resection
- Esophageal strictures or alkaline injury
- Open wound in the area to prevent ultrasonography
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 (US)US evaluation was performed after insertion of the tube via subxiphoid approach for tube passing esophagogastric (EG) junction. The tube insertion procedure will be repeated no more than three attempts if no visualization by US. | Diagnostic test | ultrasonography (US) |
| Standard routine (SR)Standard routine (SR) | Diagnostic test | Standard routine (SR) |
Primary outcome
correct rate as comparing with the chest radiography in each group
Time frame: 1 day
1 secondary outcome
procedure time, tube placement confirmation time other than chest radiography method, and additional auscultation method in US group
Time frame: 1 day
Results and safety
The study was stopped early (reason given: No obvious difference of primary outcome was detected when external reviewing). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
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.
Ying-Chun Chien, MD principal investigator
National Taiwan University Hospital
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 (US) and Standard routine (SR) in people with Ultrasound for Confirmation of Gastric Tube Placement in Critically Ill Patients Under Invasive Mechanical Ventilation, run by National Taiwan University Hospital at 1 site in Taiwan.
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 4 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 19 Jul 2024. 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 Taiwan. 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 (reason given: No obvious difference of primary outcome was detected when external reviewing). 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?
correct rate as comparing with the chest radiography in each group (time frame: 1 day). 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 19 Jul 2024.