Diagnostic Accuracy of Capnography in Nasogastric Tube Placement

Not yet recruiting

• Conditions: Diagnostic Accuracy; Nasogastric Tube; Capnography
• Interventions: Diagnostic Test: Capnography

• Registration Number: NCT05817864
• Lead Sponsor: Chinese University of Hong Kong

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.

Study Timeline

• Study First Submitted: 2023-03-23
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-05
• Last Update Submitted: 2023-04-05
• Study First Posted: 2023-04-18
• Last Update Posted: 2023-04-18
• Study Start: 2023-06
• Primary Completion: 2025-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 390

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational group	Capnography	All participants included will be in one observational cohort.

Primary Outcome Measures

Name	Time	Method
Sensitivity of Capnography	Through study completion, an average of 2 year	True Positive / (True Positive + False Negative) × 100%
Specificity of Capnography	Through study completion, an average of 2 year	True Negative / (True Negative + False Positive) × 100%
Positive Predictive Value of Capnography	Through study completion, an average of 2 year	True Positive / (True Positive + False Positive) × 100%
Negative Predictive Value of Capnography	Through study completion, an average of 2 year	True Negative / (True Negative + False Negative) × 100%
Overall diagnostic performance of Capnography	Through study completion, an average of 2 year	Measured by the area under the receiver operating characteristic curve (AUROC). The test accuracy level is considered high when the AUROC value is ≥ 0.9.

Secondary Outcome Measures

Name	Time	Method
Difference in the time spent of index test and reference test	Through study completion, an average of 2 year	Compare the time spent of index test (i.e., capnography) and reference test (i.e., radiography)
Difference in the cost of index test and reference test	Through study completion, an average of 2 year	Compare the cost of index test (i.e., capnography) and reference test (i.e., radiography)

Trial Locations

Locations (1)

The Chinese University of Hong Kong; 🇨🇳 Hong Kong, Hong Kong SAR, China