The Prediction Model of Hypoxemia for Safe Bronchoscopy

The Prediction Model of Hypoxemia for Safe Bronchoscopy Under MAC Anesthesia

The purpose of this study is to develop the hypoxemia prediction model during fiberoptic bronchoscopy under MAC(monitored anesthesia care) anesthesia.

Study Overview

• Status: Unknown
• Conditions: Obstructive Sleep Apnea; Hypoxemia

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.

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Sei Won Lee, M.D.; Phone Number: 82-31-787-7053; Email: seiwon@snubh.org

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
      • Recruiting
      • Sei Won Lee
      • Contact: Sei Won Lee, M.D.; Phone Number: 82-31-787-7053; Email: seiwon@snubh.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patienst who are planned to get fiberoptic bronchoscopy under MAC anesthesia in Seoul National University Bundang Hospital

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Lowest oxygen saturation during bronchoscopy, development of hypoxemia(SpO2<90%) during bronchoscopy	during the fiberoptic bronchoscopy, estimated procedure time is about 15min

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital
• Investigators: Principal Investigator: Sei Won Lee, M.D., Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: May 31, 2011
• First Submitted That Met QC Criteria: June 9, 2011
• First Posted (Estimate): June 10, 2011

Study Record Updates

• Last Update Posted (Estimate): June 10, 2011
• Last Update Submitted That Met QC Criteria: June 9, 2011
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Keywords: Hypoxemia; Model; Bronchoscopes; Monitored anesthesia care
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Hypoxia
• Other Study ID Numbers: SNUBH-FOB under MAC