Diagnostic Accuracy of Capnography in Nasogastric Tube Placement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

390 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-01

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparing Two Methods to Measure Nasogastric Tube Length

NCT06982495

Intubation, Nasogastric Intubation Intraesophageal Intubation Depth +2 more

NOT_YET_RECRUITING NA

Ultrasound to Check the Position of the Nasogastric Tube

NCT06635915

Nasogastric Tube Placement

RECRUITING NA

Accuracy of Ultrasonography in Confirming Correct Positioning of Nasogastric Tube in the Intensive Care Setting

NCT06693219

Nasogastric Tube Placement Accuracy Ultrasonography +1 more

COMPLETED NA

Confirmation of Nasogastric Tube Placement Via Ultrasonography

NCT00941772

Nasogastric Tube Intubation

COMPLETED NA

Is Ultrasound Comparable to Chest X-ray in Verification of Intensive Care Patients Enteral Feeding Tube Positioning.

NCT06000384

Intensive Care Patient

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Capnography Nasogastric Tube Diagnostic Accuracy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Observational group

All participants included will be in one observational cohort.

Capnography

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.