Prevalence Rate, and Clinical Characteristics of Obesity... | NCT02934581

Studies
Prevalence Rate, and Clinical Characteristics of Obesity Hypoventilation Syndrome Via Screening Patients Admitted to Medical Intensive Care Units

NCT02934581

Sponsor

National Taiwan University Hospital

Status

Completed

Last Update Posted

Mar 12, 2021Actual

Enrollment

52Actual

Phase

Not provided

Conditions

Obesity Hypoventilation Syndrome

Interventions

Not provided

Countries

Taiwan

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

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 29, 2014Actual

Primary Completion Date

Aug 12, 2016Actual

Completion Date

Oct 31, 2018Actual

First Submitted Date

Sep 20, 2016

First Submission Date that Met QC Criteria

Oct 13, 2016

First Posted Date

Oct 17, 2016Estimated

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

Mar 10, 2021

Last Update Posted Date

Mar 12, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

A prospective observation study to screen adult obese (BMI ≥30 kg/m2) patients who were newly admitted to the medical intensive care units and turned out to be diagnosed as Obesity hypoventilation syndrome(OHS). The investigators purpose is to look into the prevalence, predictive factors, and outcomes of OHS in these critically ill patients.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

52Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence of obesity hypoventilation syndrome in Asian critically ill patients	Detecting obesity hypoventilation syndrome via screening obesity(BMI>=30kg/m^2) in critical care units in Asian.	2-year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BMI ≥ 30 kg/m2
Suspected chronic hypercapnia as following Paco2 ≥ 45 mmHg, HCO3- ≥ 27mEq/L or base excess, BE ≥ 2 mEq/L

Exclusion Criteria:

Malignancy with lung involvement
Autoimmune disease with lung involvement
Moderate to severe obstructive respiratory pattern via spirometry
Uncontrolled endocrine disease
Pregnancy
Pneumonia confirmed by image
Out-of-hospital cardiac arrest
Lung edema
Foreigner of Taiwan

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

adult obese (BMI ≥30 kg/m2) patients who were newly admitted to the medical intensive care units and turned out to be diagnosed as obesity hypoventilation syndrome

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital		Taipei			Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010845	Obesity Hypoventilation Syndrome

Ancestor Terms

ID	Term
D020181	Sleep Apnea, Obstructive
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders

Browse Leaves

Not provided

Browse Branches

Not provided