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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04316988
Recruitment Status : Completed
First Posted : March 20, 2020
Last Update Posted : March 20, 2020
Sponsor:
Information provided by (Responsible Party):
Shirish Shakti Maskay, Tribhuvan University, Nepal

Brief Summary:

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.


Condition or disease Intervention/treatment
Intubation Ultrasound Imaging Capnography Diagnostic Test: Ultrasonography

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.

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Study Type : Observational
Actual Enrollment : 95 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ultrasonography Imaging Versus Waveform Capnography in Detecting Endotracheal Tube Placement During Intubation in a Tertiary Hospital.
Actual Study Start Date : January 17, 2017
Actual Primary Completion Date : July 14, 2017
Actual Study Completion Date : August 15, 2017

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04316988


Sponsors and Collaborators
Tribhuvan University, Nepal
Investigators
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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
  Study Documents (Full-Text)

Documents provided by Shirish Shakti Maskay, Tribhuvan University, Nepal:
Publications of Results:

Other Publications:
Hagberg CA, Artime CA. Airway Management in the Adult. In: Miller RD, Cohen NH, Eriksson LI, Fleisher LA, Wiener-Kronish JP, Young WL, editors. Miller's Anesthesia. 8th ed. Philadelphia: Elsevier Saunders; 2015. p. 1665-6.
Dorsch JA, Dorsch SE. Airway Equipment. In: Dorsch JA, Dorsch SE, editors. Understanding Anesthesia Equipment. 5th ed: Lippincott Williams and Wilkins; 2012. p. 593-8.
Rosenbalt WH, Sukhupragarn W. Airway Management. In: Barash PG, Cullen BF, Stoeltin RK, Cahalan MK, Stock MC, Ortega R, editors. Clinical Anesthesia. 7th ed. Philadelphia: Lipincott Williams and Wilkins; 2013. p. 774-8.
Connor CW. Commonly Used Monitoring Techniques. In: Barash PG, Cullen BF, Stoeltin RK, Cahalan MK, Stock MC, Ortega R, editors. Clinical Anesthesia. 7th ed. Philadelphia: Lippincott Williams and Wilkins; 2013. p. 704-6.
Chitilian HV, Kaczka DW, Melo MFV. Respiratory Monitoring. In: Miller RD, Cohen NH, Eriksson LI, Fleisher LA, Wiener-Kronish JP, Young WL, editors. Miller's Anesthesia. 8th ed. Philadelphia: Elsevier Saunders; 2015. p. 1551-5.

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Responsible Party: Shirish Shakti Maskay, Dr, Tribhuvan University, Nepal
ClinicalTrials.gov Identifier: NCT04316988    
Other Study ID Numbers: IOM
First Posted: March 20, 2020    Key Record Dates
Last Update Posted: March 20, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Excel worksheet of patients data log entry includes age, sex and type of surgery; without disclosing personal patient details.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Indefinite
Access Criteria: email

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shirish Shakti Maskay, Tribhuvan University, Nepal:
Endotracheal intubation; Ultrasonography; Capnography