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Transesophageal Echocardiography(TEE) Probe Insertion and Tracheal Cuff Pressure (TEE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02034643
Recruitment Status : Completed
First Posted : January 13, 2014
Last Update Posted : September 17, 2014
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital

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.

Condition or disease Intervention/treatment Phase
Intubation, Intratracheal Procedure: balloon pressure adjustment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Increase of Tracheal Cuff Pressure During Transesophageal Echocardiography Probe Insertion: Double-lumen Tube Versus Single-lumen Tube
Study Start Date : October 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Arm Intervention/treatment
patients with single-lumen tube
Patients who required intraoperative TEE and single-lumen tube; balloon pressure adjustment before TEE probe insertion
Procedure: balloon pressure adjustment
Tracheal cuff pressure was adjusted to 18 mmHg (25 cmH2O) before TEE probe insertion

patients with double-lumen tube
Patients who required intraoperative TEE and double-lumen tube; balloon pressure adjustment before TEE probe insertion
Procedure: balloon pressure adjustment
Tracheal cuff pressure was adjusted to 18 mmHg (25 cmH2O) before TEE probe insertion




Primary Outcome Measures :
  1. Tracheal cuff pressure [ Time Frame: 1 min after TEE probe insertion ]

Secondary Outcome Measures :
  1. Tracheal cuff pressure [ Time Frame: every min for 5 min after TEE probe insertion ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02034643


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02034643    
Other Study ID Numbers: YSJeon_Cuff
First Posted: January 13, 2014    Key Record Dates
Last Update Posted: September 17, 2014
Last Verified: January 2014