The Prediction Model of Hypoxemia for Safe Bronchoscopy

Obstructive Sleep Apnea Clinical Trial

Official title:

The Prediction Model of Hypoxemia for Safe Bronchoscopy Under MAC Anesthesia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01370993
• Other study ID #: SNUBH-FOB under MAC
• Status: Recruiting
• Phase: N/A
• First received: May 31, 2011
• Last updated: June 9, 2011
• Start date: May 2011
• Est. completion date: December 2012

Study information

• Verified date: May 2011
• Source: Seoul National University Bundang Hospital
• Contact: Sei Won Lee, M.D.
• Phone: 82-31-787-7053
• Email: seiwon[@]snubh.org
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypoxemia
• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
Korea, Republic of	Sei Won Lee	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lowest oxygen saturation during bronchoscopy, development of hypoxemia(SpO2<90%) during bronchoscopy		during the fiberoptic bronchoscopy, estimated procedure time is about 15min	No
Secondary	Need for oxygen flow increment		during the fiberoptic bronchoscopy, estimated procedure time is about 15min	No
Secondary	the proportion of subjects who is require of mandible lift		during the fiberoptic bronchoscopy, estimated procedure time is about 15min	No
Secondary	time delay for procedure due to hypoxemia		during the fiberoptic bronchoscopy, estimated procedure time is about 15min	Yes
Secondary	the proportion of subjects with snoring	snoring	during the fiberoptic bronchoscopy, estimated procedure time is about 15min	No