Diagnostic accuracy of point-of-care enzymatic test for nasogastric tube placement
Not Applicable
Completed
- Conditions
- Patients with nasogastric tube in place for purpose of feeding and/or medicationNot Applicable
- Registration Number
- ISRCTN11170249
- Lead Sponsor
- Imperial College London
- Brief Summary
2017 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29102995 results 2017 Other publications in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5695306/ Pre-results (added 11/07/2023) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34903303/ Development and validation (added 11/07/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 396
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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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<br>2. Number of chest radiographs requested is recorded exactly as described, when aspirates and re-attempts both fail