Diagnostic Accuracy of Capnography in Nasogastric Tube Placement
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChinese University of Hong Kong
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Participants receiving life-saving intervention at the time of recruitment.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Capnography
Diagnostic testIndex 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 determining the correct placement of nasogastric tubes. Radiology will be performed as soon as possible and interpreted by a physician. A repeat radiography will be performed if necessary. We will also use pH-Fix-4.5-10 to determine the pH value, and its accuracy is +/- 0.2 pH with minimum increments of 0.5. A pH of 5.5 or below indicates gastric placement.
Treatment groups
390 Participants
are divided into 1 treatment groupGroup A: Observational group1 intervention
Trial outcomes
Primary outcomes
1
Sensitivity of Capnography
True Positive / (True Positive + False Negative) × 100%
Time frame
Through study completion, an average of 2 year2
Specificity of Capnography
True Negative / (True Negative + False Positive) × 100%
Time frame
Through study completion, an average of 2 year3
Positive Predictive Value of Capnography
True Positive / (True Positive + False Positive) × 100%
Time frame
Through study completion, an average of 2 year4
Negative Predictive Value of Capnography
True Negative / (True Negative + False Negative) × 100%
Time frame
Through study completion, an average of 2 yearSecondary outcomes
1
Difference in the time spent of index test and reference test
Compare the time spent of index test (i.e., capnography) and reference test (i.e., radiography)
Time frame
Through study completion, an average of 2 year2
Difference in the cost of index test and reference test
Compare the cost of index test (i.e., capnography) and reference test (i.e., radiography)
Time frame
Through study completion, an average of 2 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Chinese University of Hong Kong
Lead sponsor
Hospital Authority, Hong Kong
Collaborator
Source ClinicalTrials.gov