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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02034643
Other study ID # YSJeon_Cuff
Secondary ID
Status Completed
Phase N/A
First received January 9, 2014
Last updated September 15, 2014
Start date October 2013
Est. completion date January 2014

Study information

Verified date January 2014
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date January 2014
Est. primary completion date January 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- adult patients scheduled for elective cardiothoracic surgery

- requiring intraoperative TEE monitoring

Exclusion Criteria:

- 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Tracheal cuff pressure 1 min after TEE probe insertion No
Secondary Tracheal cuff pressure every min for 5 min after TEE probe insertion No
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