Transesophageal Echocardiography(TEE) Probe Insertion and Tracheal Cuff Pressure

Intubation, Intratracheal Clinical Trial

— TEE  

Official title:

Increase of Tracheal Cuff Pressure During Transesophageal Echocardiography Probe Insertion: Double-lumen Tube Versus Single-lumen Tube

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02034643
• Other study ID #: YSJeon_Cuff
• 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

• Intubation, Intratracheal

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