The Prediction Model of Hypoxemia for Safe Bronchoscopy | NCT01370993

Studies
The Prediction Model of Hypoxemia for Safe Bronchoscopy

NCT01370993

Sponsor

Seoul National University Bundang Hospital

Status

Unknown status

Last Update Posted

Jun 10, 2011Estimated

Enrollment

150Estimated

Phase

Not provided

Conditions

Hypoxemia
Obstructive Sleep Apnea

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2011

Primary Completion Date

Dec 2012Estimated

Completion Date

Dec 2012Estimated

First Submitted Date

May 31, 2011

First Submission Date that Met QC Criteria

Jun 9, 2011

First Posted Date

Jun 10, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 9, 2011

Last Update Posted Date

Jun 10, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sei Won Lee, M.D.	Contact	82-31-787-7053		seiwon@snubh.org

Overall Officials

Name	Affiliation	Role
Sei Won Lee, M.D.	Seoul National University Bundang Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sei Won Lee	Recruiting	Seongnam-si	Gyeonggi-do	463-707	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D000860	Hypoxia
D020181	Sleep Apnea, Obstructive

Ancestor Terms

ID	Term
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D012891	Sleep Apnea Syndromes

Browse Leaves

Not provided

Browse Branches

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