Diagnostic Accuracy of Capnography in Nasogastric Tube Placement

Official title

Diagnostic Accuracy of Using Capnography in Verification of Nasogastric Tube Placement in Hospital Settings

Overview

A prospective observational diagnostic study will be conducted to assess the sensitivity and specificity of using capnography in detecting the correct placement of nasogastric tubes using the reference standards of radiography and measurement of aspirates for pH value.

Detailed description

A prospective observational diagnostic study will be conducted. Patients ≥ 18-year-old and requiring the insertion of an nasogastric tube will be recruited using a convenience sampling method from general medical and geriatric wards, intensive care units (ICUs), accident and emergency departments (AEDs), and subacute/rehabilitation/infirmary wards in 21 acute or subacute/convalescent/extended care hospitals. End-tidal carbon dioxide (ETCO2) detection by sidestream capnography, which indicates airway intubation of an nasogastric tube when a capnogram waveform or an ETCO2 level \> 10 mmHg, will serve as the index test. The reference standards will be the pH value of gastric content aspiration (pH ≤ 5.5 indicates gastric placement) and X-ray performed after the index test. Each participant will be included only once. Sensitivity, specificity, positive predictive value, and negative predictive value, and the area under the receiver operating characteristic curve of capnography will be calculated to assess the diagnostic performance of capnography. The variability in diagnostic accuracy in participants with different characteristics will be compared. The time spent and the cost of the index test and the reference test will be compared.

This study will provide evidence on the diagnostic accuracy of capnography in verifying nasogastric tube placement and inform the update of clinical practice guidelines and stakeholders' decisions regarding the adoption of ETCO2 detection as a routine method for verifying nasogastric tube placement.

Interventions

• Diagnostic test Capnography
  Index test: Capnography, which monitors ETCO2, the percentage concentration, or partial pressure of CO2 at the end of exhalation, will serve as the index test. It will be performed by connecting the end of the nasogastric tube with the sensor of the bedside sidestream capnography device. Placement within the airway is defined as detecting a capnogram waveform or an ETCO2 level \> 10 mmHg. Reference standard: This study will use radiography (chest/abdominal X-ray) as the reference standard for d

Primary outcome measures

• Sensitivity of Capnography [Time frame: Through study completion, an average of 2 year]
• Specificity of Capnography [Time frame: Through study completion, an average of 2 year]
• Positive Predictive Value of Capnography [Time frame: Through study completion, an average of 2 year]
• Negative Predictive Value of Capnography [Time frame: Through study completion, an average of 2 year]
• Overall diagnostic performance of Capnography [Time frame: Through study completion, an average of 2 year]

Secondary outcome measures (2)

• Difference in the time spent of index test and reference test [Time frame: Through study completion, an average of 2 year]
• Difference in the cost of index test and reference test [Time frame: Through study completion, an average of 2 year]

Eligibility criteria

Inclusion criteria

• 18 years old or above;
• Admitted to the general medical and geriatric wards, ICUs, or subacute/rehabilitation/infirmary wards in subacute/convalescent/extended care hospitals or visiting AEDs in acute hospitals;
• Requiring the insertion of an nasogastric tube into the stomach for assessment, nutritional support and medication administration during the study period.

Exclusion criteria

• Participants receiving life-saving intervention at the time of recruitment.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

China · 1 center

• The Chinese University of Hong Kong — Hong Kong

Publications

• Chau JP, Thompson DR, Fernandez R, Griffiths R, Lo HS. Methods for determining the correct nasogastric tube placement after insertion: a meta-analysis. JBI Libr Syst Rev. 2009;7(16):679-760. doi: 10.11124/01938924-200907160-00001. PMID 27820026
• Chau JP, Lo SH, Thompson DR, Fernandez R, Griffiths R. Use of end-tidal carbon dioxide detection to determine correct placement of nasogastric tube: a meta-analysis. Int J Nurs Stud. 2011 Apr;48(4):513-21. doi: 10.1016/j.ijnurstu.2010.12.004. Epub 2011 Jan 7. PMID 21215969
• Chau JPC, Liu X, Choi KC, Lo SHS, Lam SKY, Chan KM, Zhao J, Thompson DR. Diagnostic accuracy of end-tidal carbon dioxide detection in determining correct placement of nasogastric tube: An updated systematic review with meta-analysis. Int J Nurs Stud. 2021 Nov;123:104071. doi: 10.1016/j.ijnurstu.2021.104071. Epub 2021 Aug 24. PMID 34520886
• Chau JPC, Tong DWK, Lo SHS, Sze SYM, Kwok MLM, Lai PCK, Lam HKC, Chung JYM, Liu X, Chien WT, Choi KC. Diagnostic accuracy of using capnography in verification of nasogastric tube placement among adult patients in hospital settings: Protocol of a diagnostic study. PLoS One. 2023 Oct 23;18(10):e0292667. doi: 10.1371/journal.pone.0292667. eCollection 2023. PMID 37871102

Identifiers

NCT: NCT05817864 · 2022073

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗