Utility of Tracheal Ultrasonography for the Confirmation of the Endotracheal Tube Placement

• Sponsor: Marmara University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03220698
• Collaborator: (none)
• Enrollment: 360
• Actual Duration (Months): 12

Study Details

Study Description

Brief Summary

The aim of this study is to compare tracheal ultrasound with direct visualization of tracheal rings for the confirmation of endotracheal tube placement in intubated patients. We hypothesize that this method is more reliable, cheap, and readily available for all emergency physicians.

Condition or Disease	Intervention/Treatment	Phase
Intubation Complication	Device: Tracheal ultrasonography

Detailed Description

Confirmation of the ETT placement has utmost importance in the management of airway in emergency medicine (EM). Visual examination of the tube (fogging), auscultation, chest x-ray, capnography, capnometry and fiberoptic bronchoscopy are the main tools used for confirmation with increasing diagnostic utilities. Recently, tracheal ultrasonography (US) was introduced as a reliable, cheap and readily available method of confirmation of ETT placement.

Study Design

• Study Type: Observational
• Actual Enrollment: 360 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Utility of Tracheal Ultrasonography for the Confirmation of Endotracheal Tube Placement During Intubation: A Diagnostic Accuracy Study
• Actual Study Start Date: Jan 1, 2016
• Actual Primary Completion Date: Jan 1, 2017
• Actual Study Completion Date: Jan 1, 2017

Outcome Measures

Primary Outcome Measures

1. Presence of endotracheal tube in trachea [Immediately after the intubation process]

   Whether the endotracheal tube is in the trachea or not

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• adults (>=18 years)

• intubated in the ED

• during the shifts of the researchers (TM, OFC).

Exclusion Criteria:

• anatomical, traumatic or tumoral defect(s) at the site of sonographic imaging

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Marmara University

Investigators

• Principal Investigator: Haldun Akoglu, MD, Marmara University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Haldun Akoglu, Associate Professor of Emergency Medicine, Marmara University
• ClinicalTrials.gov Identifier: NCT03220698
• Other Study ID Numbers: 09.2016.054
• First Posted: Jul 18, 2017
• Last Update Posted: Jul 18, 2017
• Last Verified: Jul 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Haldun Akoglu, Associate Professor of Emergency Medicine, Marmara University: endotracheal intubation; confirmation; ultrasonography

Study Results

No Results Posted as of Jul 18, 2017