Prevention of misplacement of nasogastric tubes in patients Other
Conditions
Interventions
The PID is a prototype medical device. It utilises an imaging implementation technique known as time-correlated single-photon counting (TCSPC) to provide a healthcare practitioner with guidance in the
Sponsors
The University of Edinburgh & Lothian Health Board ACCORD
Eligibility
Sex/Gender
All
Age
16 Years to 75 Years
Inclusion criteria
Inclusion criteria: All participants inclusion: 1. Adults aged 16 to 75 years inclusive on the day of enrolment 2. Has capacity to provide written, informed consent 3. Deemed suitable for all study procedures by clinical member of the research team 4. Complies with co-enrolment criteria Healthy volunteers specific inclusion: 1. In good general health Patient specific inclusion: 1. NG tube required as part of clinical care
Exclusion criteria
Exclusion criteria: Healthy Volunteer Exclusion: 1. Previous intolerance of NG tube insertion 2. Recent mid face trauma 3. Recent nasal surgery 4. Recent pharyngeal surgery 5. Recent laryngeal surgery 6. Currently prescribed medication which causes therapeutic anticoagulation 7. History of bleeding diathesis 8. History of cirrhosis 9. Stigmata of chronic liver disease 10. Known oesophageal varices 11. History of dysphagia 12. Women (of childbearing potential*) who are pregnant, planning to become pregnant or are breastfeeding 13. Currently detained under the Mental Health Act 14. Any clinically significant abnormal finding, disease or disorder which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data Patients Exclusion: 1. Women (of childbearing potential*) who are pregnant, planning to become pregnant or are breastfeeding 2. Treated in isolation for infection control purposes 3. Any clinically significant abnormal finding on clinical examination or screening investigations 4. Currently detained under the Mental Health Act
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity (of correct NG tube tip detection in the GI tract below the oesophago-gastric junction or not as confirmed by chest x-ray) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Sensitivity (of correct NG tube tip detection in the GI tract below the oesophago-gastric junction or not as confirmed by CXR) in the days after initial NGT placement (patients) 2. Sensitivity (of correct NG tube tip detection in the GI tract below the oesophago-gastric junction or not as confirmed by CXR) in healthy volunteers 3. For repeated visits only. Narrative recording of any barriers to procedure via investigation team debrief. Clinical user to record narrative user acceptability feedback following each patient procedure 4. SAE rate measured using patient records 5. Median duration of PID procedure 6. Reasons for withdrawal of consent during or following the procedure (if obtained) | — |
Countries
Scotland, United Kingdom
Contacts
Public ContactBeatrice Selby
Outcome results
None listed