Diagnostic Accuracy of Using Point-of-care Ultrasonography for Confirming Nasogastric Tube Placement

NCT06821737 | Active Not Recruiting FDA Device

• 1 other identifier: CIRB-2024-467-2
• Study Type: observational
• Target: 530
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ultrasound; Nasogastric Tube; Nasogastric Tube Placement

Outcome Measures

Primary Outcomes (1)

• 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

  An average of 18 months

Secondary Outcomes (3)

• Time lag between USG & x-ray

  An average of 18 months

• Delay between tube placement and feeding by x-ray

  An average of 18 months

• Cost of ED admission, unplanned admission, ambulance transportation

  An average of 18 months

Study Arms (1)

Observational Group

All participants included will be in one observational cohort.

Device: Diagnostic ultrasound; Device: Diagnostic X-ray

Interventions

Diagnostic ultrasound DEVICE

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.

Observational Group

Diagnostic X-ray DEVICE

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.

Observational Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pamela Youde Nethersole Eastern Hospital: lead

Study Sites (1)

Hospital Authority, HKSAR

Hong Kong, Hong Kong

Location

Related Publications (11)

• 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.

  PMID: 26511519 BACKGROUND

• Zatelli 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.

  PMID: 28298944 BACKGROUND

• Wong 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.

  PMID: 28038826 BACKGROUND

• Tsujimoto 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.

  PMID: 39051488 BACKGROUND

• Nedel 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.

  PMID: 28828174 BACKGROUND

• Mumoli 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.

  PMID: 33545162 BACKGROUND

• McMullen 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.

  PMID: 34120804 BACKGROUND

• Mak 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.

  PMID: 32614666 BACKGROUND

• Lin 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.

  PMID: 28359986 BACKGROUND

• Gok 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.

  PMID: 25616518 BACKGROUND

• Brun 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.

  PMID: 25181712 BACKGROUND

MeSH Terms

Interventions

Ultrasonography; Radiography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse Consultant

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 12, 2025
• Study Start: April 28, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2028
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)