Diagnostic Accuracy of Capnography in Nasogastric Tube Placement

NCT05817864 | Recruiting DMC

• 1 other identifier: 2022073
• Study Type: observational
• Target: 390
• Locations: 1 country
• Sites: 1

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.

Conditions

Capnography; Nasogastric Tube; Diagnostic Accuracy

Keywords

Capnography; Intubation, gastrointestinal; Diagnostic accuracy

Outcome Measures

Primary Outcomes (5)

• Sensitivity of Capnography

  True Positive / (True Positive + False Negative) × 100%

  Through study completion, an average of 2 year

• Specificity of Capnography

  True Negative / (True Negative + False Positive) × 100%

  Through study completion, an average of 2 year

• Positive Predictive Value of Capnography

  True Positive / (True Positive + False Positive) × 100%

  Through study completion, an average of 2 year

• Negative Predictive Value of Capnography

  True Negative / (True Negative + False Negative) × 100%

  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.

  Through study completion, an average of 2 year

Secondary Outcomes (2)

• Difference in the time spent of index test and reference test

  Through study completion, an average of 2 year

• Difference in the cost of index test and reference test

  Through study completion, an average of 2 year

Study Arms (1)

Observational group

All participants included will be in one observational cohort.

Diagnostic Test: Capnography

Interventions

Capnography 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.

Observational group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Hospital Authority, Hong Kong: collaborator

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong SAR, China

RECRUITING

Related Publications (4)

• 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.

  PMID: 27820026 BACKGROUND

• Chau 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.

  PMID: 21215969 BACKGROUND

• Chau 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.

  PMID: 34520886 BACKGROUND

• Chau 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.

  PMID: 37871102 DERIVED

MeSH Terms

Interventions

Capnography

Intervention Hierarchy (Ancestors)

Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Janita Pak Chun Chau, PhD

CONTACT

+852 3943 6226; janitachau@cuhk.edu.hk

Suzanne Hoi Shan Lo, PhD

CONTACT

+852 3943 4485; suzannelo@cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: April 18, 2023
• Study Start: July 1, 2023
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 5, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)