- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02634047
Use of McGrath Videolaryngoscope to Assist Transesophageal Echocardiography Probe Insertion in Intubated Patients
Use of McGrath Videolaryngoscope to Assist Transesophageal Echocardiography Probe Insertion in Intubated Patients: A Prospective Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
Eighty adult patients, who received general anaesthesia for elective open heart surgeries that required transesophageal echocardiography insertion, will be randomized by means of a computer-generated randomization order into two groups: Conventional group (Group C), and videolaryngoscope group (group VL).
Success rate of the selected technique (first attempt and overall), duration of insertion for selected technique, complications such as oropharyngeal mucosal injury and hematoma will be noted.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Antalya, Turkey, 07100
- Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients who received general anaesthesia for open heart surgeries that required transesophageal echocardiography probe insertion
Exclusion Criteria:
- patients younger than 18 years and older than 70 years
- oropharengeal infection
- esophageal injury and anatomic abnormalities
- known or predicted difficult airway
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: conventional technique
transesophageal echocardiography probe was inserted using a traditional blind insertion technique.
|
transesophageal echocardiography probe was inserted using a traditional blind insertion technique.
|
Experimental: videolaryngoscope technique
transesophageal echocardiography probe was advanced into esophagus under direct vision using videolaryngoscope
|
transesophageal echocardiography probe was advanced into esophagus under direct vision using videolaryngoscope
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
difference in the first attempt and overall success rate
Time Frame: participants will be followed from the beginning of the transesophageal echocardiography probe insertion through the mouth to the confirmation of successful insertion (10 minutes)
|
investigate the difference in the first attempt and overall success rate (with percentage) of different techniques for insertion of transesophageal echocardiography probe.
|
participants will be followed from the beginning of the transesophageal echocardiography probe insertion through the mouth to the confirmation of successful insertion (10 minutes)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
difference of the duration of insertion and complications during insertion
Time Frame: participants will be followed for the duration of intraoperative period and postoperative 8 hours.
|
investigate the difference of the duration of insertion (in seconds) using the selected technique and complications (with number and percentage) during insertion such as oropharyngeal mucosal injury and hematoma.
|
participants will be followed for the duration of intraoperative period and postoperative 8 hours.
|
Collaborators and Investigators
Investigators
- Study Director: Nılgun Kavrut Ozturk, MD, Antalya Training And Research Hospital
Publications and helpful links
General Publications
- Chang JE, Min SW, Kim CS, Lee JM, No H, Hwang JY. Effect of Jaw Thrust on Transesophageal Echocardiography Probe Insertion and Concomitant Oropharyngeal Injury. J Cardiothorac Vasc Anesth. 2015 Oct;29(5):1266-71. doi: 10.1053/j.jvca.2015.02.003. Epub 2015 Feb 7.
- Na S, Kim CS, Kim JY, Cho JS, Kim KJ. Rigid laryngoscope-assisted insertion of transesophageal echocardiography probe reduces oropharyngeal mucosal injury in anesthetized patients. Anesthesiology. 2009 Jan;110(1):38-40. doi: 10.1097/ALN.0b013e318190b56e.
- Aviv JE, Di Tullio MR, Homma S, Storper IS, Zschommler A, Ma G, Petkova E, Murphy M, Desloge R, Shaw G, Benjamin S, Corwin S. Hypopharyngeal perforation near-miss during transesophageal echocardiography. Laryngoscope. 2004 May;114(5):821-6. doi: 10.1097/00005537-200405000-00006.
- Hirabayashi Y, Okada O, Seo N. Airtraq laryngoscope for the insertion of a transesophageal echocardiography probe. J Cardiothorac Vasc Anesth. 2008 Apr;22(2):331-2. doi: 10.1053/j.jvca.2007.06.012. Epub 2007 Aug 22. No abstract available.
- Hirabayashi Y. GlideScope-assisted insertion of a transesophageal echocardiography probe. J Cardiothorac Vasc Anesth. 2007 Aug;21(4):628. doi: 10.1053/j.jvca.2006.11.015. Epub 2007 Feb 22. No abstract available.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AntalyaTRH 009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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