Intubation Clinical Trial
Official title:
Ultrasonography Imaging Versus Waveform Capnography in Detecting Endotracheal Tube Placement During Intubation in a Tertiary Hospital.
NCT number | NCT04316988 |
Other study ID # | IOM |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 17, 2017 |
Est. completion date | August 15, 2017 |
Verified date | March 2020 |
Source | Tribhuvan University, Nepal |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Tribhuvan University, Nepal |
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
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.
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
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.
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
Grmec S. Comparison of three different methods to confirm tracheal tube placement in emergency intubation. Intensive Care Med. 2002 Jun;28(6):701-4. Epub 2002 Apr 30. — View Citation
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.
Hajian-Tilaki K. Sample size estimation in diagnostic test studies of biomedical informatics. J Biomed Inform. 2014 Apr;48:193-204. doi: 10.1016/j.jbi.2014.02.013. Epub 2014 Feb 26. — View Citation
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
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 |
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