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The Effect of Esophageal Temperature Probe Insertion on Tracheal Cuff Pressure

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: NCT03375554
Recruitment Status : Completed
First Posted : December 18, 2017
Last Update Posted : August 18, 2020
Sponsor:
Collaborator:
SMG-SNU Boramae Medical Center
Information provided by (Responsible Party):
Jung-Man Lee, Seoul National University Hospital

Study Description
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Brief Summary:
The goal of this prospective observational study is to investigate the effect on esophageal stethoscope insertion on tracheal cuff pressure during general anesthesia.

Condition or disease
Intubation Complication

Detailed Description:

It is well known that cuff pressure of tracheal tube should not be over 30 cmH2O. Therefore, anesthesiologists usually pay attention to maintain adequate cuff pressure, especially just after completion of tracheal intubation. Recently, esophageal stethoscope is widely used for exact monitoring of patient's body temperature. However, inserting of foreign body in esophagus could affect on the cuff pressure.

The goal of this prospective observational study is to investigate the effect on esophageal stethoscope insertion on tracheal cuff pressure.

Study Design
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Study Type : Observational
Actual Enrollment : 112 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Esophageal Temperature Probe Insertion on Tracheal Cuff Pressure
Actual Study Start Date : April 4, 2018
Actual Primary Completion Date : June 5, 2018
Actual Study Completion Date : June 6, 2018
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Change of cuff pressure [ Time Frame: intraoperative ]
    Change of cuff pressure by inserting of esophageal stethoscope, compared with before insertion of it


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patient receiving general anesthesia for elective surgery
Criteria

Inclusion Criteria:

  • Patient receiving general anesthesia for elective surgery

Exclusion Criteria:

  • who doesn't agree to enroll
  • who has any clinical disease or history of surgery in esophagus
  • who has aspiration tendency
Contacts and Locations
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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): NCT03375554


Locations
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Korea, Republic of
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, Korea, Republic of, 07061
Sponsors and Collaborators
Seoul National University Hospital
SMG-SNU Boramae Medical Center
Investigators
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Principal Investigator: Jung-Man Lee, M.D.,PhD SMG-SNU Boramae Medical Center
More Information
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Responsible Party: Jung-Man Lee, Clinical assistant professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03375554    
Other Study ID Numbers: 16-2017-78
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: August 18, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jung-Man Lee, Seoul National University Hospital:
esophageal steothoscope, tracheal intubation