CapnographyNCT05817864
Diagnostic Accuracy of Capnography in Nasogastric Tube Placement
An observational study of Capnography and Nasogastric Tube, run by Chinese University of Hong Kong at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Capnography, Nasogastric Tube, Diagnostic Accuracy
- What is being tested?
- Capnography
- How many people
- 390 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Participants receiving life-saving intervention at the time of recruitment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Chinese University of Hong Kong
Hong Kong, Hong Kong SAR
Janita Pak Chun Chau, PhD, +852 3943 6226, janitachau@cuhk.edu.hk
About this study
Official title: Diagnostic Accuracy of Using Capnography in Verification of Nasogastric Tube Placement in Hospital Settings
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.
Read the 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.
- Conditions
- Capnography, Nasogastric Tube, Diagnostic Accuracy
- Being tested
- Capnography
- Keywords
- Capnography, Intubation, gastrointestinal, Diagnostic accuracy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapnographyDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Observational group | All participants included will be in one observational cohort. Receives: Diagnostic Test: Capnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of Capnography
True Positive / (True Positive + False Negative) × 100%
Measured: Through study completion, an average of 2 year
Specificity of Capnography
True Negative / (True Negative + False Positive) × 100%
Measured: Through study completion, an average of 2 year
Positive Predictive Value of Capnography
True Positive / (True Positive + False Positive) × 100%
Measured: Through study completion, an average of 2 year
Negative Predictive Value of Capnography
True Negative / (True Negative + False Negative) × 100%
Measured: Through study completion, an average of 2 year
Overall diagnostic performance of Capnography
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.
Measured: Through study completion, an average of 2 year
Secondary outcomes (2)
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)
Measured: Through study completion, an average of 2 year
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)
Measured: Through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start1 Jul 2023
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CapnographyStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Authority, Hong Kong
- Responsible party
- Principal investigator, Chau Pak Chun Janita, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05817864
- Sponsor's protocol ID
- 2022073
- Status last verified
- Sep 2024
- First submitted
- 23 Mar 2023
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets generated during and/or analysed during the current study will be available from the principal investigator on reasonable request.
Publications
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.
PubMed 27820026Chau 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.
PubMed 21215969Chau 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.
PubMed 34520886Chau JPC, Tong DWK, Lo SHS, Sze SYM, Kwok MLM, Lai PCK, Lam HKC, Chung JYM, Liu X, Chien WT, Choi KC. Diagnostic accuracy of using capnography in verification of nasogastric tube placement among adult patients in hospital settings: Protocol of a diagnostic study. PLoS One. 2023 Oct 23;18(10):e0292667. doi: 10.1371/journal.pone.0292667. eCollection 2023.
PubMed 37871102
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Using Capnography in Verification of Nasogastric Tube Placement in Hospital Settings
- ClinicalTrials.gov ID
- NCT05817864
- Acronym / sponsor ID
- 2022073
- Conditions
- Capnography, Nasogastric Tube, Diagnostic Accuracy
- Keywords
- Capnography, Intubation, gastrointestinal, Diagnostic accuracy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Hospital Authority, Hong Kong
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational group | – | Diagnostic Test: CapnographyAll participants included will be in one observational cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Participants receiving life-saving intervention at the time of recruitment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CapnographyIndex 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. | Diagnostic test | Observational group |
Primary outcome
Sensitivity of Capnography
Time frame: Through study completion, an average of 2 year
True Positive / (True Positive + False Negative) × 100%
Specificity of Capnography
Time frame: Through study completion, an average of 2 year
True Negative / (True Negative + False Positive) × 100%
Positive Predictive Value of Capnography
Time frame: Through study completion, an average of 2 year
True Positive / (True Positive + False Positive) × 100%
Negative Predictive Value of Capnography
Time frame: Through study completion, an average of 2 year
True Negative / (True Negative + False Negative) × 100%
Overall diagnostic performance of Capnography
Time frame: 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.
2 secondary outcomes
Difference in the time spent of index test and reference test
Time frame: Through study completion, an average of 2 year
Difference in the cost of index test and reference test
Time frame: Through study completion, an average of 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
- Background: PubMed 27820026Chau 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.
- Background: PubMed 21215969Chau 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.
- Background: PubMed 34520886Chau 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.
- Derived from this study: PubMed 37871102Chau JPC, Tong DWK, Lo SHS, Sze SYM, Kwok MLM, Lai PCK, Lam HKC, Chung JYM, Liu X, Chien WT, Choi KC. Diagnostic accuracy of using capnography in verification of nasogastric tube placement among adult patients in hospital settings: Protocol of a diagnostic study. PLoS One. 2023 Oct 23;18(10):e0292667. doi: 10.1371/journal.pone.0292667. eCollection 2023.
- Individual participant dataSharing planned: No. The datasets generated during and/or analysed during the current study will be available from the principal investigator on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Capnography and Nasogastric Tube, run by Chinese University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Janita Pak Chun Chau, PhD (+852 3943 6226, janitachau@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of Capnography (time frame: Through study completion, an average of 2 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05817864, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2024.