Ultrasonography Versus Capnography in Detecting Endotracheal Tube Placement During Intubation in a Tertiary Hospital.

March 18, 2020 updated by: Shirish Shakti Maskay, Tribhuvan University, Nepal

Ultrasonography Imaging Versus Waveform Capnography in Detecting Endotracheal Tube Placement During Intubation in a Tertiary Hospital.

After endotracheal intubation verifying the location of endotracheal tube is of utmost importance. Many methods have been applied but none is perfect. The standard practice in the investigator's center has been to use auscultation of chest with capnography.

Ultrasound machines are now gaining popularity and their access extends from operation theatres, emergency rooms and even many primary health centres. Both capnography and ultrasonography are safe.

This study found out that Ultrasonography and waveform capnography are both reliable methods of confirming endotracheal tube position. The use of ultrasound could help reduce time and increase precision of confirming endotracheal tube position. Ultrasound can confirm endotracheal tube position before manual bag ventilations, and thus may prevent aspiration of gastric contents into patient's lungs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This was a prospective, observational study conducted at the Tribhuvan University Teaching Hospital (TUTH) and Manmohan Cardiothoracic Vascular and Transplant Center (MCVTC) operating rooms from January 2017 to July 2017. Ethical approval from the Institutional Review Board (IRB) of Institute of Medicine (IOM) and the Department of Anaesthesiology, Maharajgunj Medical College (MMC) was taken. Written informed consent was taken.

ASA I and II patients over 16 years of age were included in this study. Patients with difficult airway and anticipated difficult intubation, respiratory diseases, poor functional status, emergency case, and patients at risk of aspiration were excluded.

The diagnostic characteristics of real-time, suprasternal, transtracheal ultrasonography and capnography were tested by calculating their respective sensitivities, specificities, positive predictive values (PPV), negative predictive values (NPV), accuracies and likelihood ratios. Comparison of time taken for confirmation of endotracheal tube position from the beginning of laryngoscopy, by ultrasonography versus capnography was done using t-statistics.

The degree of agreement of result between ultrasonography and capnography was tested with kappa statistics.

Out of the 95 patients studied, 11 had oesophageal intubation (Incidence of 11.57%). The overall accuracy of both ultrasonography and capnography was 96.84%. The sensitivity, specificity, PPV, NPV with their corresponding 95% confidence intervals (CI) for ultrasonography were 97.62% (91.66% - 99.71%), 90.91% (58.72% - 99.77%), 98.80% (92.67% - 99.81%), 83.33% (55.66% - 95.22%) respectively; and that for capnography were 96.43% (89.92% - 99.26%), 100% (71.51% - 100%), 100% (100% - 100%) and 78.57% (54.69% - 91.76%) respectively.

The likelihood ratio of a positive and a negative result for ultrasonography were 10.74 and 0.03 respectively, and that for capnography were infinity and 0.04 respectively.

The kappa value was 0.749 (95% CI: 0.567 - 0.931) which meant a good degree of agreement of result between these two methods.

The average time taken for confirmation of endotracheal tube by ultrasonography and capnography were 26.79 ± 7.64 seconds and 43.03 ± 8.71 seconds (mean ± standard deviation) respectively. The median time for confirmation was 26 seconds with interquartile range [15 - 37] seconds for ultrasonography and 42 seconds with interquartile range [29 - 55] seconds for capnography. Ultrasonography was found to be faster than capnography by 16.36 ± 3.23 seconds (mean ± standard deviation) and the difference in time was significant (p = 0.011).

During the study, one patient had unanticipated difficult intubation, and four had hypotension after induction of anaesthesia. These patients were excluded from the study and no sequalae of hypotension was seen in the patients, or no hypoxemia occured in the patient with unanticipated difficult intubation.

Study Type

Observational

Enrollment (Actual)

95

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

American Society of Anesthesiologist classified status I and II patients from Nepalsese population, without any selection for gender, caste or ethnicity, and above 16 years of age.

Description

Inclusion Criteria:

  • ASA I and II patients of both sexes above 16 years of age undergoing general anaesthesia with endotracheal tube placement.

Exclusion Criteria:

  • - Patient refusal
  • ASA physical status III and above
  • History of prior difficult bag and mask ventilation or difficult intubation
  • History of prior oro-nasal or neck injuries, burns or scars
  • Active oral, pharyngeal or tracheal infection or inflammatory changes
  • Anticipated difficult airway or difficult intubation during preanaesthetic examination, with Mallampati grades II and above
  • Lung parenchymal and pleural diseases. Examples: asthma, COPD, bronchiectasis, reactive lung diseases, pneumonia, tuberculosis, pleural effusion, pneumothorax, lung or pleural malignancy etc.
  • Emergency surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ultrasonography
Ultrasonography group in whom after endotracheal intubation, the endotracheal tube position was confirmed by ultrasound machine over the trachea.
Diagnostic test: Ultrasonography
A real time 2D ultrasound evaluation was done over the trachea of the patient.
Capnography
Capnography group in whom after endotracheal intubation, the endotracheal tube position was confirmed by capnograph, evaluationg the graph character and end tidal CO2 value.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ULTRASONOGRAPHY IMAGING VERSUS WAVEFORM CAPNOGRAPHY IN DETECTING ENDOTRACHEAL TUBE PLACEMENT DURING INTUBATION IN A TERTIARY HOSPITAL
Time Frame: 6 months
Ultrasonography and waveform capnography are both reliable and accurate methods of confirming endotracheal tube position
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ultrasonography compared to capnography for confirming the endotacheal tube position after intuabtion
Time Frame: 6 months
  • Using real-time transtracheal ultrasound can help confirm endotracheal tube position earlier than capnography.
  • Using real-time transtracheal ultrasound will help avoid manual bag ventilations to confirm endotracheal tube position and can prevent aspiration of gastric contents into lungs in cases of oesophageal intubation.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tribhuvan University, Nepal

Investigators

  • Study Chair: BISHWAS PRADHAN, MD, FCTA, Manmohan Cardiothoracic Vascular and Transplant Center, IOM
  • Study Director: NINADINI SHRESTHA, MD, FIPM, TU Teaching Hospital, IOM
  • Study Director: PRISKA BASTOLA, MD, Manmohan Cardiothoracic Vascular and Transplant Center, IOM

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2017

Primary Completion (Actual)

July 14, 2017

Study Completion (Actual)

August 15, 2017

Study Registration Dates

First Submitted

March 13, 2020

First Submitted That Met QC Criteria

March 18, 2020

First Posted (Actual)

March 20, 2020

Study Record Updates

Last Update Posted (Actual)

March 20, 2020

Last Update Submitted That Met QC Criteria

March 18, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IOM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Excel worksheet of patients data log entry includes age, sex and type of surgery; without disclosing personal patient details.

IPD Sharing Time Frame

Indefinite

IPD Sharing Access Criteria

email

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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