Use of McGrath Videolaryngoscope to Assist Transesophageal Echocardiography Probe Insertion in Intubated Patients

Other Complications of Surgical and Medical Procedures Clinical Trial

Official title:

Use of McGrath Videolaryngoscope to Assist Transesophageal Echocardiography Probe Insertion in Intubated Patients: A Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02634047
• Other study ID #: AntalyaTRH 009
• Status: Completed
• Phase: N/A
• First received: December 10, 2015
• Last updated: December 15, 2015
• Start date: September 2015
• Est. completion date: November 2015

Study information

• Verified date: December 2015
• Source: Antalya Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The primary aim of this study is to investigate the difference in the first attempt and overall success rate of different techniques for insertion of transesophageal echocardiography. Secondary aim is to investigate the difference of the duration of insertion using the selected technique, complications during insertion such as oropharyngeal mucosal injury and hematoma.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Other Complications of Surgical and Medical Procedures

Intervention

Device:
• conventional technique
transesophageal echocardiography probe was inserted using a traditional blind insertion technique.
• videolaryngoscope technique
transesophageal echocardiography probe was advanced into esophagus under direct vision using videolaryngoscope

Locations

Country	Name	City	State
Turkey	Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Antalya Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

Hirabayashi Y. GlideScope-assisted insertion of a transesophageal echocardiography probe. J Cardiothorac Vasc Anesth. 2007 Aug;21(4):628. Epub 2007 Feb 22. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	difference in the first attempt and overall success rate	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)	No
Secondary	difference of the duration of insertion and complications during insertion	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.	No