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Diagnostic accuracy of point-of-care enzymatic test for nasogastric tube placement

A diagnostic accuracy study to evaluate a point-of-care lipase/pH test strip to confirm correct nasogastric tube position

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN11170249
Enrollment
145
Registered
2017-06-21
Start date
2016-12-14
Completion date
Unknown
Last updated
2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with nasogastric tube in place for purpose of feeding and/or medication Not Applicable

Interventions

The study will be undertaken in two phases: Phase 1 - Diagnostic accuracy study The gold standard (reference test) will be chest x-ray if undertaken or if not required the initiation of nasogastric f

Sponsors

Imperial College London
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients who require the insertion of nasogastric tubes for supplementary enteral feeding as part of their clinical management 2. Aged 18 years old and over

Exclusion criteria

Exclusion criteria: 1. Under the age of 18 years 2. Unable to sign consent 3. Not providing consent - updated 01/02/2019: Patients who lack capacity 4. Prisoners 5. Patients sectioned under the Mental Health Act

Design outcomes

Primary

MeasureTime frame
Sensitivity of the index test and the reference tests (standard pH test) under cut-off 5.5 with tube sites confirmed by either patient follow up or chest x-rays when applicable.

Secondary

MeasureTime frame
1. Percentage unable to aspirate is measured by the number of patients for whom no aspirate is obtained out of the total number of patients for whom the attempts have been made before either successful aspiration or before chest x-rays has to be requested 2. Number of chest radiographs requested is recorded exactly as described, when aspirates and re-attempts both fail

Countries

England, United Kingdom

Contacts

Public ContactFatima Akbar
f.akbar@imperial.ac.uk+44 (0)203 3126532

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 25, 2026