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

Intubation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04316988
• Other study ID #: IOM
• Status: Completed
• Start date: January 17, 2017
• Est. completion date: August 15, 2017

Study information

• Verified date: March 2020
• Source: Tribhuvan University, Nepal
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: August 15, 2017
• Est. primary completion date: July 14, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Capnography
• Intubation
• Ultrasound Imaging

Intervention

Diagnostic Test:
• Ultrasonography
A real time 2D ultrasound evaluation was done over the trachea of the patient.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tribhuvan University, Nepal

References & Publications (23)

Abhishek C, Munta K, Rao SM, Chandrasekhar CN. End-tidal capnography and upper airway ultrasonography in the rapid confirmation of endotracheal tube placement in patients requiring intubation for general anaesthesia. Indian J Anaesth. 2017 Jun;61(6):486-4 — View Citation

Adi O, Chuan TW, Rishya M. A feasibility study on bedside upper airway ultrasonography compared to waveform capnography for verifying endotracheal tube location after intubation. Crit Ultrasound J. 2013 Jul 4;5(1):7. doi: 10.1186/2036-7902-5-7. — View Citation

Brun PM, Bessereau J, Cazes N, Querellou E, Chenaitia H. Lung ultrasound associated to capnography to verify correct endotracheal tube positioning in prehospital. Am J Emerg Med. 2012 Nov;30(9):2080.e5-6. doi: 10.1016/j.ajem.2011.10.023. Epub 2011 Dec 26. — View Citation

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Chou EH, Dickman E, Tsou PY, Tessaro M, Tsai YM, Ma MH, Lee CC, Marshall J. Ultrasonography for confirmation of endotracheal tube placement: a systematic review and meta-analysis. Resuscitation. 2015 May;90:97-103. doi: 10.1016/j.resuscitation.2015.02.013 — View Citation

Chou HC, Chong KM, Sim SS, Ma MH, Liu SH, Chen NC, Wu MC, Fu CM, Wang CH, Lee CC, Lien WC, Chen SC. Real-time tracheal ultrasonography for confirmation of endotracheal tube placement during cardiopulmonary resuscitation. Resuscitation. 2013 Dec;84(12):170 — View Citation

Chou HC, Tseng WP, Wang CH, Ma MH, Wang HP, Huang PC, Sim SS, Liao YC, Chen SY, Hsu CY, Yen ZS, Chang WT, Huang CH, Lien WC, Chen SC. Tracheal rapid ultrasound exam (T.R.U.E.) for confirming endotracheal tube placement during emergency intubation. Resusci — View Citation

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.

Das SK, Choupoo NS, Haldar R, Lahkar A. Transtracheal ultrasound for verification of endotracheal tube placement: a systematic review and meta-analysis. Can J Anaesth. 2015 Apr;62(4):413-23. doi: 10.1007/s12630-014-0301-z. Epub 2014 Dec 24. Review. — View Citation

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Gottlieb M, Bailitz JM, Christian E, Russell FM, Ehrman RR, Khishfe B, Kogan A, Ross C. Accuracy of a novel ultrasound technique for confirmation of endotracheal intubation by expert and novice emergency physicians. West J Emerg Med. 2014 Nov;15(7):834-9. — View Citation

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Karacabey S, Sanri E, Gencer EG, Guneysel O. Tracheal ultrasonography and ultrasonographic lung sliding for confirming endotracheal tube placement: Speed and Reliability. Am J Emerg Med. 2016 Jun;34(6):953-6. doi: 10.1016/j.ajem.2016.01.027. Epub 2016 Jan — View Citation

Knapp S, Kofler J, Stoiser B, Thalhammer F, Burgmann H, Posch M, Hofbauer R, Stanzel M, Frass M. The assessment of four different methods to verify tracheal tube placement in the critical care setting. Anesth Analg. 1999 Apr;88(4):766-70. — View Citation

Kundra P, Mishra SK, Ramesh A. Ultrasound of the airway. Indian J Anaesth. 2011 Sep;55(5):456-62. doi: 10.4103/0019-5049.89868. — View Citation

Li J. Capnography alone is imperfect for endotracheal tube placement confirmation during emergency intubation. J Emerg Med. 2001 Apr;20(3):223-9. — View Citation

Milling TJ, Jones M, Khan T, Tad-y D, Melniker LA, Bove J, Yarmush J, SchianodiCola J. Transtracheal 2-d ultrasound for identification of esophageal intubation. J Emerg Med. 2007 May;32(4):409-14. Epub 2007 Apr 16. Erratum in: J Emerg Med. 2007 Aug;33(2): — View Citation

Pfeiffer P, Rudolph SS, Børglum J, Isbye DL. Temporal comparison of ultrasound vs. auscultation and capnography in verification of endotracheal tube placement. Acta Anaesthesiol Scand. 2011 Nov;55(10):1190-5. doi: 10.1111/j.1399-6576.2011.02501.x. Epub 20 — View Citation

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.

Rudraraju P, Eisen LA. Confirmation of endotracheal tube position: a narrative review. J Intensive Care Med. 2009 Sep-Oct;24(5):283-92. doi: 10.1177/0885066609340501. Epub 2009 Aug 3. Review. — View Citation

Wojtczak JA, Cattano D. Laryngo-tracheal ultrasonography to confirm correct endotracheal tube and laryngeal mask airway placement. J Ultrason. 2014 Dec;14(59):362-6. doi: 10.15557/JoU.2014.0037. Epub 2014 Dec 30. — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ULTRASONOGRAPHY IMAGING VERSUS WAVEFORM CAPNOGRAPHY IN DETECTING ENDOTRACHEAL TUBE PLACEMENT DURING INTUBATION IN A TERTIARY HOSPITAL	Ultrasonography and waveform capnography are both reliable and accurate methods of confirming endotracheal tube position	6 months
Secondary	Ultrasonography compared to capnography for confirming the endotacheal tube position after intuabtion	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