NCT02634047

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

September 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 10, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 17, 2015

Completed
Last Updated

December 17, 2015

Status Verified

December 1, 2015

Enrollment Period

2 months

First QC Date

December 10, 2015

Last Update Submit

December 15, 2015

Conditions

Other Complications of Surgical and Medical Procedures

Keywords

transesophageal echocardiographyvideolaryngoscopeoropharyngeal injury

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (1)

  • difference of the duration of insertion and complications during insertion

    participants will be followed for the duration of intraoperative period and postoperative 8 hours.

Study Arms (2)

conventional technique

ACTIVE COMPARATOR

transesophageal echocardiography probe was inserted using a traditional blind insertion technique.

Device: conventional technique

videolaryngoscope technique

EXPERIMENTAL

transesophageal echocardiography probe was advanced into esophagus under direct vision using videolaryngoscope

Device: videolaryngoscope technique

Interventions

conventional techniqueDEVICE

transesophageal echocardiography probe was inserted using a traditional blind insertion technique.

conventional technique
videolaryngoscope techniqueDEVICE

transesophageal echocardiography probe was advanced into esophagus under direct vision using videolaryngoscope

videolaryngoscope technique

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who received general anaesthesia for open heart surgeries that required transesophageal echocardiography probe insertion

You may not qualify if:

  • patients younger than 18 years and older than 70 years
  • oropharengeal infection
  • esophageal injury and anatomic abnormalities
  • known or predicted difficult airway

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation

Antalya, 07100, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    PMID: 25976603BACKGROUND

  • 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.

    PMID: 19104168BACKGROUND

  • 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.

    PMID: 15126737BACKGROUND

  • 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.

    PMID: 18375345BACKGROUND

  • 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.

    PMID: 17678807BACKGROUND

Study Officials

  • Nılgun Kavrut Ozturk, MD

    Antalya Training and Research Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2015

First Posted

December 17, 2015

Study Start

September 1, 2015

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

December 17, 2015

Record last verified: 2015-12

Locations

TU(1)