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NCT Number: NCT06821737

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Authority, HKSAR

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Time lag between USG & x-ray

    Time frame: An average of 18 months

    The study will assess the time lag between ultrasound confirmation and subsequent X-ray imaging for nasogastric tube placement verification.

  2. Delay between tube placement and feeding by x-ray

    Time frame: An average of 18 months

    The study will evaluate the delay between nasogastric tube placement and the initiation of feeding, as confirmed by X-ray.

  3. Cost of ED admission, unplanned admission, ambulance transportation

    Time frame: An average of 18 months

    The study will analyze costs associated with Emergency Department admissions, unplanned hospital admissions, and ambulance transportation related to nasogastric tube placement confirmation.

Sponsors and collaborators

Lead sponsor

Pamela Youde Nethersole Eastern Hospital

Other

Registry information

Official study title

Diagnostic Accuracy of Using Point-of-care Ultrasonography for Confirming Nasogastric Tube Placement: a Multicentre Prospective Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Feb 12, 2025
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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