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The Prediction Model of Hypoxemia for Safe Bronchoscopy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2011 by Seoul National University Bundang Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01370993
First Posted: June 10, 2011
Last Update Posted: June 10, 2011
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.
Information provided by:
Seoul National University Bundang Hospital
  Purpose
The purpose of this study is to develop the hypoxemia prediction model during fiberoptic bronchoscopy under MAC(monitored anesthesia care) anesthesia.

Condition
Hypoxemia Obstructive Sleep Apnea

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Prediction Model of Hypoxemia for Safe Bronchoscopy Under MAC Anesthesia

Resource links provided by NLM:


Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • Lowest oxygen saturation during bronchoscopy, development of hypoxemia(SpO2<90%) during bronchoscopy [ Time Frame: during the fiberoptic bronchoscopy, estimated procedure time is about 15min ]

Secondary Outcome Measures:
  • Need for oxygen flow increment [ Time Frame: during the fiberoptic bronchoscopy, estimated procedure time is about 15min ]
  • the proportion of subjects who is require of mandible lift [ Time Frame: during the fiberoptic bronchoscopy, estimated procedure time is about 15min ]
  • time delay for procedure due to hypoxemia [ Time Frame: during the fiberoptic bronchoscopy, estimated procedure time is about 15min ]
  • the proportion of subjects with snoring [ Time Frame: during the fiberoptic bronchoscopy, estimated procedure time is about 15min ]
    snoring


Estimated Enrollment: 150
Study Start Date: May 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Detailed Description:
Currently, diverse sedatives and analgesic methods are used during fiberoptic bronchoscopy for reducing patients' discomfort and facilities of procedures as British Thoracic Society recommendation. MAC anesthesia, one of the widely used sedative method during bronchoscopy, have many advantages, occurrence of respiratory depression, hypoxemia are not uncommon during the procedures. The investigators try to find out risk factors and develop the prediction model for hypoxemia during bronchoscopy under MAC anesthesia.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patienst who are planned to get fiberoptic bronchoscopy under MAC anesthesia in Seoul National University Bundang Hospital
Criteria

Inclusion Criteria:

  • Age> 15 yrs
  • patients who are planned to get fiberoptic bronchoscopy under MAC anesthesia in Seoul National University Bundang Hospital

Exclusion Criteria:

  • Patients who will get Endobronchial ultrasound guided transbronchial needle aspiration
  • patients whose baseline oxygen saturation is below 90%
  • Intubated patients
  • Patients do not agree with the study enrollment
  Contacts and Locations
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): NCT01370993


Contacts
Contact: Sei Won Lee, M.D. 82-31-787-7053 seiwon@snubh.org

Locations
Korea, Republic of
Sei Won Lee Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Contact: Sei Won Lee, M.D.    82-31-787-7053    seiwon@snubh.org   
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
Principal Investigator: Sei Won Lee, M.D. Seoul National University Bundang Hospital
  More Information

Responsible Party: Sei Won Lee/Assistant professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01370993     History of Changes
Other Study ID Numbers: SNUBH-FOB under MAC
First Submitted: May 31, 2011
First Posted: June 10, 2011
Last Update Posted: June 10, 2011
Last Verified: May 2011

Keywords provided by Seoul National University Bundang Hospital:
Hypoxemia
Model
Bronchoscopes
Monitored anesthesia care

Additional relevant MeSH terms:
Sleep Apnea, Obstructive
Hypoxia
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms