Clinical trial NCT05817864: Diagnostic Accuracy of Capnography in Nasogastric Tube Placement
Official title: Diagnostic Accuracy of Using Capnography in Verification of Nasogastric Tube Placement in Hospital Settings
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Capnography
Nasogastric Tube
Diagnostic Accuracy
Keywords: Capnography
Intubation, gastrointestinal
Diagnostic accuracy
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Hospital Authority, Hong Kong
First posted: 2023-04-18
Enrollment: 390
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A convenience sampling method will be adopted in this study. The participants will be recruited from general medical and geriatric wards, ICUs, AEDs, and subacute/rehabilitation/infirmary wards in 21 acute or subacute/convalescent/extended care hospitals. Each participant will be included in the study once.

Brief summary: 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.

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.

Primary outcomes:
measure: Sensitivity of Capnography
timeFrame: Through study completion, an average of 2 year
measure: Specificity of Capnography
timeFrame: Through study completion, an average of 2 year
measure: Positive Predictive Value of Capnography
timeFrame: Through study completion, an average of 2 year
measure: Negative Predictive Value of Capnography
timeFrame: Through study completion, an average of 2 year
measure: Overall diagnostic performance of Capnography
timeFrame: Through study completion, an average of 2 year
Secondary outcomes:
measure: Difference in the time spent of index test and reference test
timeFrame: Through study completion, an average of 2 year
measure: Difference in the cost of index test and reference test
timeFrame: Through study completion, an average of 2 year
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: The Chinese University of Hong Kong
state: Hong Kong SAR
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.