NCT04316988

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 17, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2017

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 20, 2020

Completed
Last Updated

March 20, 2020

Status Verified

March 1, 2020

Enrollment Period

6 months

First QC Date

March 13, 2020

Last Update Submit

March 18, 2020

Conditions

Keywords

Endotracheal intubation; Ultrasonography; Capnography

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Ultrasonography compared to capnography for confirming the endotacheal tube position after intuabtion

    6 months

Study Arms (2)

Ultrasonography

Ultrasonography group in whom after endotracheal intubation, the endotracheal tube position was confirmed by ultrasound machine over the trachea.

Diagnostic Test: Ultrasonography

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.

Interventions

UltrasonographyDIAGNOSTIC_TEST

A real time 2D ultrasound evaluation was done over the trachea of the patient.

Ultrasonography

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (23)

  • 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.

    PMID: 19654121BACKGROUND
  • 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.

    PMID: 26672974BACKGROUND
  • 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.

    PMID: 22174461BACKGROUND
  • 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.

    PMID: 24582925BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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. Resuscitation. 2011 Oct;82(10):1279-84. doi: 10.1016/j.resuscitation.2011.05.016. Epub 2011 Jun 1.

  • 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 26.

  • Pfeiffer P, Rudolph SS, Borglum 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 2011 Sep 8.

  • 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.

  • 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. Epub 2015 Feb 21.

  • 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. doi: 10.1016/j.jemermed.2006.08.022. Epub 2007 Apr 16.

  • 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.

  • 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.

  • Li J. Capnography alone is imperfect for endotracheal tube placement confirmation during emergency intubation. J Emerg Med. 2001 Apr;20(3):223-9. doi: 10.1016/s0736-4679(00)00318-8.

  • 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. doi: 10.1097/00000539-199904000-00016.

  • Grmec S. Comparison of three different methods to confirm tracheal tube placement in emergency intubation. Intensive Care Med. 2002 Jun;28(6):701-4. doi: 10.1007/s00134-002-1290-x. Epub 2002 Apr 30.

  • 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. doi: 10.5811/westjem.22550.9.22550. Epub 2014 Nov 24.

  • 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):1708-12. doi: 10.1016/j.resuscitation.2013.06.018. Epub 2013 Jul 9.

  • 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):486-489. doi: 10.4103/ija.IJA_544_16.

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • BISHWAS PRADHAN, MD, FCTA

    Manmohan Cardiothoracic Vascular and Transplant Center, IOM

    STUDY CHAIR
  • NINADINI SHRESTHA, MD, FIPM

    TU Teaching Hospital, IOM

    STUDY DIRECTOR
  • PRISKA BASTOLA, MD

    Manmohan Cardiothoracic Vascular and Transplant Center, IOM

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

March 13, 2020

First Posted

March 20, 2020

Study Start

January 17, 2017

Primary Completion

July 14, 2017

Study Completion

August 15, 2017

Last Updated

March 20, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
Indefinite
Access Criteria
email