NCT02034643

Brief Summary

Tracheal cuff overinflation is known to reduce tracheal mucosal blood flow and to increase tracheal morbidity. Transesophageal echocardiography (TEE) probe insertion may increase the tracheal cuff pressure. The aim of this study is to evaluate the effect of TEE probe insertion on tracheal cuff pressure and to compare the effects in single-lumen tube and double-lumen tube.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2013

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

October 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 13, 2014

Completed
Last Updated

September 17, 2014

Status Verified

January 1, 2014

Enrollment Period

3 months

First QC Date

January 9, 2014

Last Update Submit

September 15, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Tracheal cuff pressure

    1 min after TEE probe insertion

Secondary Outcomes (1)

  • Tracheal cuff pressure

    every min for 5 min after TEE probe insertion

Study Arms (2)

patients with single-lumen tube

OTHER

Patients who required intraoperative TEE and single-lumen tube; balloon pressure adjustment before TEE probe insertion

Procedure: balloon pressure adjustment

patients with double-lumen tube

OTHER

Patients who required intraoperative TEE and double-lumen tube; balloon pressure adjustment before TEE probe insertion

Procedure: balloon pressure adjustment

Interventions

Tracheal cuff pressure was adjusted to 18 mmHg (25 cmH2O) before TEE probe insertion

patients with double-lumen tubepatients with single-lumen tube

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients scheduled for elective cardiothoracic surgery
  • requiring intraoperative TEE monitoring

You may not qualify if:

  • patients with tracheal stenosis
  • patients with tracheoesophageal fistula
  • patients with esophageal surgery
  • patients with esophageal varix
  • patients with Barrett esophagus
  • patients with esophageal hernia
  • patients with descending thoracic aorta aneurysm
  • patients with dysphagia
  • patients with vocal fold palsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

  • Kim TK, Min JJ, Seo JH, Lee YH, Ju JW, Bahk JH, Hong DM, Jeon Y. Increased tracheal cuff pressure during insertion of a transoesophageal echocardiography probe: A prospective, observational study. Eur J Anaesthesiol. 2015 Aug;32(8):549-54. doi: 10.1097/EJA.0000000000000204.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2014

First Posted

January 13, 2014

Study Start

October 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

September 17, 2014

Record last verified: 2014-01

Locations