UltrasoundNCT06821737
Diagnostic Accuracy of Using Point-of-care Ultrasonography for Confirming Nasogastric Tube Placement
An observational study of Ultrasound and Nasogastric Tube, run by Pamela Youde Nethersole Eastern Hospital at 1 site in Hong Kong.
Trial summary
A prospective observational diagnostic study will be conducted to assess the sensitivity and specificity of ultrasound in verifying the correct nasogastric tube placement, using X-ray as the reference standard. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ultrasound, Nasogastric Tube, Nasogastric Tube Placement
- What is being tested?
- Diagnostic ultrasound and Diagnostic X-ray
- Type of treatment
- Medical device
- How many people
- 675 participants
- Where
- 1 siteHong Kong
- Study dates
- 28 Apr 2025to 30 Aug 2026
- Phase
- Observational
- 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
Study population: Convenience sampling will be adopted in this study. Participants will be recruited from six community nursing centres in Hong Kong East, Hong Kong West, Kowloon Central, Kowloon West, and New Territories West Cluster hospitals, as well as 38 wards from medical and geriatric wards across 4 acute, rehabilitation or convalescent hospitals managed by the Hospital Authority. Participants will be engaged by episodes throughout the study.
Who may be able to join
- Aged 18 or older;
- Living in the community or admitted to a medical and geriatric ward;
- Requiring the use of an NGT during the recruitment period for assessment, monitoring, nutritional assistance, drainage, and/or medication administration;
- Aspirated fluids with a pH value of more than 5.5 after insertion or with insufficient fluids for pH testing after insertion;
Who cannot join
- Uncooperative patients;
- Had head and neck injury
- Have had a gastrectomy or by-pass surgery;
- History of abdominal trauma or receiving emergency life support intervention at time of recruitment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Accuracy of Using Point-of-care Ultrasonography for Confirming Nasogastric Tube Placement: a Multicentre Prospective Study
A prospective observational diagnostic study will be conducted to assess the sensitivity and specificity of ultrasound in verifying the correct nasogastric tube placement, using X-ray as the reference standard.
Read the detailed description
This study is a prospective observational diagnostic investigation aimed at evaluating the accuracy of ultrasound in confirming nasogastric tube (NGT) placement. Participants aged 18 years or older requiring NGT insertion will be recruited via convenience sampling from community nursing centres across five clusters and medical and geriatric wards in four acute or convalescent hospitals. Nurses performing index tests will complete standardized POCUS training (8-hour theory and practical sessions, written exams, 3-month bedside practicum with ≥20 positive scans) prior to competency assessment. Direct visualisation of an NGT in both the oesophagus and stomach will be interpreted as correct stomach placement. When the acoustic shadow of an NGT was not seen in the stomach, 50cc of air was injected through the NGT, and it was considered well-placed if the ultrasonography showed dynamic fogging. Correct gastric placement is assumed if the acoustic shadow of an NGT is visible in the oesophagus and stomach, even if fogging is not detectable. The reference standard will be post-index test X-ray confirmation. Diagnostic performance metrics, including sensitivity, specificity, positive and negative predictive values, and likelihood ratios, will be calculated to assess the efficacy of ultrasound. Variability in diagnostic accuracy across participant characteristics will be analyzed. Additionally, the study will compare the time intervals between ultrasound and X-ray, delays in feeding initiation post-placement, and associated costs, including emergency department admissions, unplanned hospitalizations, and ambulance transportation.
The findings will provide critical evidence on the diagnostic utility of ultrasound for NGT placement verification, informing potential revisions to clinical practice guidelines and supporting stakeholder decisions on integrating ultrasound as a reference test.
- Conditions
- Ultrasound, Nasogastric Tube, Nasogastric Tube Placement
- Being tested
- Diagnostic ultrasound, Diagnostic X-ray
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic ultrasoundDevice
A portable wireless ultrasound system (Vscan Air, General Electric Healthcare) with dual probes-linear array (3-12 MHz) for neck scanning and curved array (2-5 MHz) for subxiphoid scanning-will be used. The linear probe is placed transversely on the anterior neck, slid left at the thyroid level to focus on the esophagus, then rotated for longitudinal views. The curved probe is applied subxiphoid, using the liver as a landmark, and tilted left to image the stomach. A positive result is confirmed by visualizing the NGT shadow in the esophagus and stomach, followed by dynamic upsurge fogging after injecting 50cc of air. Ultrasonography and X-ray results will be compared.
Diagnostic X-rayDevice
This study will employ chest radiography as the reference standard for verification of correct nasogastric tube placement. Radiographic imaging will be conducted following NGT insertion and interpreted by physicians to verify positional accuracy.
| Study group | Role | What they receive |
|---|---|---|
| Observational Group | All participants included will be in one observational cohort. Receives: Device: Diagnostic ultrasound; Device: Diagnostic X-ray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy of Ultrasound in correct Nasogastric Tube placement confirmation
Sensitivity: True Positive / (True Positive + False Negative) x 100% Specificity: True Negative / (True Negative + False Positive) x 100% Positive Predictive Value: True Positive / (True Positive + False Positive) x 100% Negative Predictive Value: True Negative / (True Negative + False Negative) x 100% Positive Likelihood Ratio: sensitivity / 1 - specificity Negative Likelihood Ratio: 1 - sensitivity / specificity
Measured: An average of 18 months
Secondary outcomes (3)
Time lag between USG & x-ray
The study will assess the time lag between ultrasound confirmation and subsequent X-ray imaging for nasogastric tube placement verification.
Measured: An average of 18 months
Delay between tube placement and feeding by x-ray
The study will evaluate the delay between nasogastric tube placement and the initiation of feeding, as confirmed by X-ray.
Measured: An average of 18 months
Cost of ED admission, unplanned admission, ambulance transportation
The study will analyze costs associated with Emergency Department admissions, unplanned hospital admissions, and ambulance transportation related to nasogastric tube placement confirmation.
Measured: An average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start28 Apr 2025
- Primary completion24 Feb 2026
- Study completion30 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for UltrasoundStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 675 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamela Youde Nethersole Eastern Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mak Mei Yi, Pamela Youde Nethersole Eastern Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06821737
- Sponsor's protocol ID
- CIRB-2024-467-2
- Status last verified
- Sep 2026
- First submitted
- 6 Feb 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The datasets generated and/or analyzed during this study will be made available by the principal investigator upon reasonable request.
Publications
Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig L, Lijmer JG, Moher D, Rennie D, de Vet HC, Kressel HY, Rifai N, Golub RM, Altman DG, Hooft L, Korevaar DA, Cohen JF; STARD Group. STARD 2015: an updated list of essential items for reporting diagnostic accuracy studies. BMJ. 2015 Oct 28;351:h5527. doi: 10.1136/bmj.h5527.
PubMed 26511519Zatelli M, Vezzali N. 4-Point ultrasonography to confirm the correct position of the nasogastric tube in 114 critically ill patients. J Ultrasound. 2016 Oct 28;20(1):53-58. doi: 10.1007/s40477-016-0219-0. eCollection 2017 Mar.
PubMed 28298944Wong KW, Chan HH, Wong CP, Chan MY, Chau JCW, Wong TW. Using color flow detection of air insufflation to improve accuracy in verifying nasogastric tube position. Am J Emerg Med. 2017 Feb;35(2):333-336. doi: 10.1016/j.ajem.2016.12.046. Epub 2016 Dec 21.
PubMed 28038826Tsujimoto Y, Kataoka Y, Banno M, Anan K, Shiroshita A, Jujo S. Ultrasonography for confirmation of gastric tube placement. Cochrane Database Syst Rev. 2024 Jul 25;7(7):CD012083. doi: 10.1002/14651858.CD012083.pub3.
PubMed 39051488Nedel WL, Jost MNF, Filho JWF. A simple and fast ultrasonographic method of detecting enteral feeding tube placement in mechanically ventilated, critically ill patients. J Intensive Care. 2017 Aug 18;5:55. doi: 10.1186/s40560-017-0249-5. eCollection 2017.
PubMed 28828174Mumoli N, Vitale J, Pagnamenta A, Mastroiacovo D, Cei M, Pomero F, Giorgi-Pierfranceschi M, Giuntini L, Porta C, Capra R, Mazzone A, Dentali F. Bedside Abdominal Ultrasound in Evaluating Nasogastric Tube Placement: A Multicenter, Prospective, Cohort Study. Chest. 2021 Jun;159(6):2366-2372. doi: 10.1016/j.chest.2021.01.058. Epub 2021 Feb 2.
PubMed 33545162McMullen CD, Anstey C, Garrett P, Moore J. Nasogastric tube placement under sonographic observation: A comparison study of ultrasound and chest radiography in mechanically ventilated patients. Aust Crit Care. 2022 Mar;35(2):181-185. doi: 10.1016/j.aucc.2021.03.006. Epub 2021 Jun 11.
PubMed 34120804Mak MY, Tam G. Ultrasonography for nasogastric tube placement verification: an additional reference. Br J Community Nurs. 2020 Jul 2;25(7):328-334. doi: 10.12968/bjcn.2020.25.7.328.
PubMed 32614666Lin T, Gifford W, Lan Y, Qin X, Liu X, Wang J, Yang B, You T, Chen K. Diagnostic accuracy of ultrasonography for detecting nasogastric tube (NGT) placement in adults: A systematic review and meta analysis. Int J Nurs Stud. 2017 Jun;71:80-88. doi: 10.1016/j.ijnurstu.2017.03.005. Epub 2017 Mar 9.
PubMed 28359986Gok F, Kilicaslan A, Yosunkaya A. Ultrasound-guided nasogastric feeding tube placement in critical care patients. Nutr Clin Pract. 2015 Apr;30(2):257-60. doi: 10.1177/0884533614567714. Epub 2015 Jan 23.
PubMed 25616518Brun PM, Chenaitia H, Lablanche C, Pradel AL, Deniel C, Bessereau J, Melaine R. 2-point ultrasonography to confirm correct position of the gastric tube in prehospital setting. Mil Med. 2014 Sep;179(9):959-63. doi: 10.7205/MILMED-D-14-00044.
PubMed 25181712
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Using Point-of-care Ultrasonography for Confirming Nasogastric Tube Placement: a Multicentre Prospective Study
- ClinicalTrials.gov ID
- NCT06821737
- Acronym / sponsor ID
- CIRB-2024-467-2
- Conditions
- Ultrasound, Nasogastric Tube, Nasogastric Tube Placement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 675 participants (actual)
- Lead sponsor
- Pamela Youde Nethersole Eastern HospitalUniversity, hospital or other
- Study start
- 28 Apr 2025 (actual)
- Primary completion
- 24 Feb 2026 (actual)
- Study completion
- 30 Aug 2026 (actual)
- First posted
- 12 Feb 2025 (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.
A prospective observational diagnostic study will be conducted to assess the sensitivity and specificity of ultrasound in verifying the correct nasogastric tube placement, using X-ray as the reference standard.
Detailed description
This study is a prospective observational diagnostic investigation aimed at evaluating the accuracy of ultrasound in confirming nasogastric tube (NGT) placement. Participants aged 18 years or older requiring NGT insertion will be recruited via convenience sampling from community nursing centres across five clusters and medical and geriatric wards in four acute or convalescent hospitals. Nurses performing index tests will complete standardized POCUS training (8-hour theory and practical sessions, written exams, 3-month bedside practicum with ≥20 positive scans) prior to competency assessment. Direct visualisation of an NGT in both the oesophagus and stomach will be interpreted as correct stomach placement. When the acoustic shadow of an NGT was not seen in the stomach, 50cc of air was injected through the NGT, and it was considered well-placed if the ultrasonography showed dynamic fogging. Correct gastric placement is assumed if the acoustic shadow of an NGT is visible in the oesophagus and stomach, even if fogging is not detectable. The reference standard will be post-index test X-ray confirmation. Diagnostic performance metrics, including sensitivity, specificity, positive and negative predictive values, and likelihood ratios, will be calculated to assess the efficacy of ultrasound. Variability in diagnostic accuracy across participant characteristics will be analyzed. Additionally, the study will compare the time intervals between ultrasound and X-ray, delays in feeding initiation post-placement, and associated costs, including emergency department admissions, unplanned hospitalizations, and ambulance transportation.
The findings will provide critical evidence on the diagnostic utility of ultrasound for NGT placement verification, informing potential revisions to clinical practice guidelines and supporting stakeholder decisions on integrating ultrasound as a reference test.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational Group | – | Device: Diagnostic ultrasound, Device: Diagnostic X-rayAll participants included will be in one observational cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Convenience sampling will be adopted in this study. Participants will be recruited from six community nursing centres in Hong Kong East, Hong Kong West, Kowloon Central, Kowloon West, and New Territories West Cluster hospitals, as well as 38 wards from medical and geriatric wards across 4 acute, rehabilitation or convalescent hospitals managed by the Hospital Authority. Participants will be engaged by episodes throughout the study.
Key inclusion criteria (4 listed)
- Aged 18 or older;
- Living in the community or admitted to a medical and geriatric ward;
- Requiring the use of an NGT during the recruitment period for assessment, monitoring, nutritional assistance, drainage, and/or medication administration;
- Aspirated fluids with a pH value of more than 5.5 after insertion or with insufficient fluids for pH testing after insertion;
Key exclusion criteria (4 listed)
- Uncooperative patients;
- Had head and neck injury
- Have had a gastrectomy or by-pass surgery;
- History of abdominal trauma or receiving emergency life support intervention at time of recruitment.
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 |
|---|---|---|
| Diagnostic ultrasoundA portable wireless ultrasound system (Vscan Air, General Electric Healthcare) with dual probes-linear array (3-12 MHz) for neck scanning and curved array (2-5 MHz) for subxiphoid scanning-will be used. The linear probe is placed transversely on the anterior neck, slid left at the thyroid level to focus on the esophagus, then rotated for longitudinal views. The curved probe is applied subxiphoid, using the liver as a landmark, and tilted left to image the stomach. A positive result is confirmed by visualizing the NGT shadow in the esophagus and stomach, followed by dynamic upsurge fogging after injecting 50cc of air. Ultrasonography and X-ray results will be compared. | Device | Observational Group |
| Diagnostic X-rayThis study will employ chest radiography as the reference standard for verification of correct nasogastric tube placement. Radiographic imaging will be conducted following NGT insertion and interpreted by physicians to verify positional accuracy. | Device | Observational Group |
Primary outcome
Diagnostic Accuracy of Ultrasound in correct Nasogastric Tube placement confirmation
Time frame: An average of 18 months
Sensitivity: True Positive / (True Positive + False Negative) x 100% Specificity: True Negative / (True Negative + False Positive) x 100% Positive Predictive Value: True Positive / (True Positive + False Positive) x 100% Negative Predictive Value: True Negative / (True Negative + False Negative) x 100% Positive Likelihood Ratio: sensitivity / 1 - specificity Negative Likelihood Ratio: 1 - sensitivity / specificity
3 secondary outcomes
Time lag between USG & x-ray
Time frame: An average of 18 months
Delay between tube placement and feeding by x-ray
Time frame: An average of 18 months
Cost of ED admission, unplanned admission, ambulance transportation
Time frame: An average of 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Background: PubMed 26511519Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig L, Lijmer JG, Moher D, Rennie D, de Vet HC, Kressel HY, Rifai N, Golub RM, Altman DG, Hooft L, Korevaar DA, Cohen JF; STARD Group. STARD 2015: an updated list of essential items for reporting diagnostic accuracy studies. BMJ. 2015 Oct 28;351:h5527. doi: 10.1136/bmj.h5527.
- Background: PubMed 28298944Zatelli M, Vezzali N. 4-Point ultrasonography to confirm the correct position of the nasogastric tube in 114 critically ill patients. J Ultrasound. 2016 Oct 28;20(1):53-58. doi: 10.1007/s40477-016-0219-0. eCollection 2017 Mar.
- Background: PubMed 28038826Wong KW, Chan HH, Wong CP, Chan MY, Chau JCW, Wong TW. Using color flow detection of air insufflation to improve accuracy in verifying nasogastric tube position. Am J Emerg Med. 2017 Feb;35(2):333-336. doi: 10.1016/j.ajem.2016.12.046. Epub 2016 Dec 21.
- Background: PubMed 39051488Tsujimoto Y, Kataoka Y, Banno M, Anan K, Shiroshita A, Jujo S. Ultrasonography for confirmation of gastric tube placement. Cochrane Database Syst Rev. 2024 Jul 25;7(7):CD012083. doi: 10.1002/14651858.CD012083.pub3.
- Background: PubMed 28828174Nedel WL, Jost MNF, Filho JWF. A simple and fast ultrasonographic method of detecting enteral feeding tube placement in mechanically ventilated, critically ill patients. J Intensive Care. 2017 Aug 18;5:55. doi: 10.1186/s40560-017-0249-5. eCollection 2017.
- Background: PubMed 33545162Mumoli N, Vitale J, Pagnamenta A, Mastroiacovo D, Cei M, Pomero F, Giorgi-Pierfranceschi M, Giuntini L, Porta C, Capra R, Mazzone A, Dentali F. Bedside Abdominal Ultrasound in Evaluating Nasogastric Tube Placement: A Multicenter, Prospective, Cohort Study. Chest. 2021 Jun;159(6):2366-2372. doi: 10.1016/j.chest.2021.01.058. Epub 2021 Feb 2.
- Background: PubMed 34120804McMullen CD, Anstey C, Garrett P, Moore J. Nasogastric tube placement under sonographic observation: A comparison study of ultrasound and chest radiography in mechanically ventilated patients. Aust Crit Care. 2022 Mar;35(2):181-185. doi: 10.1016/j.aucc.2021.03.006. Epub 2021 Jun 11.
- Background: PubMed 32614666Mak MY, Tam G. Ultrasonography for nasogastric tube placement verification: an additional reference. Br J Community Nurs. 2020 Jul 2;25(7):328-334. doi: 10.12968/bjcn.2020.25.7.328.
- Background: PubMed 28359986Lin T, Gifford W, Lan Y, Qin X, Liu X, Wang J, Yang B, You T, Chen K. Diagnostic accuracy of ultrasonography for detecting nasogastric tube (NGT) placement in adults: A systematic review and meta analysis. Int J Nurs Stud. 2017 Jun;71:80-88. doi: 10.1016/j.ijnurstu.2017.03.005. Epub 2017 Mar 9.
- Background: PubMed 25616518Gok F, Kilicaslan A, Yosunkaya A. Ultrasound-guided nasogastric feeding tube placement in critical care patients. Nutr Clin Pract. 2015 Apr;30(2):257-60. doi: 10.1177/0884533614567714. Epub 2015 Jan 23.
- Background: PubMed 25181712Brun PM, Chenaitia H, Lablanche C, Pradel AL, Deniel C, Bessereau J, Melaine R. 2-point ultrasonography to confirm correct position of the gastric tube in prehospital setting. Mil Med. 2014 Sep;179(9):959-63. doi: 10.7205/MILMED-D-14-00044.
- Individual participant dataSharing planned: No. The datasets generated and/or analyzed during this study will be made available by the principal investigator upon reasonable request.
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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?
An observational study of Ultrasound and Nasogastric Tube, run by Pamela Youde Nethersole Eastern Hospital at 1 site in Hong Kong.
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 4 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: finished, as of the sponsor's last update on 16 Sep 2026. 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 Hong Kong. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Diagnostic Accuracy of Ultrasound in correct Nasogastric Tube placement confirmation (time frame: An average of 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06821737, which also lists 11 linked publications.
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 16 Sep 2026.