RecruitingNCT05817864

Diagnostic Accuracy of Capnography in Nasogastric Tube Placement

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


Sponsor

Chinese University of Hong Kong

Enrollment

390 participants

Start Date

Jul 1, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates whether capnography — measuring carbon dioxide levels in exhaled breath — can accurately confirm that a nasogastric (NG) tube has been correctly placed in the stomach rather than accidentally in the lung. NG tubes are commonly inserted in hospital patients for feeding, medication delivery, and stomach decompression. Misplacement into the respiratory tract is a known but serious complication, and current standard confirmation methods (X-ray) are not always immediately available. Eligible participants are adults aged 18 or older admitted to hospitals (including general wards, ICUs, and rehabilitation units) who require NG tube insertion during the study period. Patients who are receiving emergency life-saving procedures at the time of recruitment are excluded. During tube insertion, capnography readings are recorded and compared against standard X-ray confirmation to assess accuracy. Misplaced NG tubes can cause fatal complications when feeds are inadvertently administered into the lung. If capnography proves reliable as a bedside confirmation method, it could replace or supplement X-ray in many settings — providing faster, cheaper, and radiation-free verification of tube placement and improving patient safety across hospitals worldwide.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTCapnography

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 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.


Locations(1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong SAR, China

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NCT05817864


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