NCT02934581

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 29, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 20, 2016

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 17, 2016

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2018

Completed
Last Updated

March 12, 2021

Status Verified

October 1, 2016

Enrollment Period

1.8 years

First QC Date

September 20, 2016

Last Update Submit

March 10, 2021

Conditions

Obesity Hypoventilation Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Obesity Hypoventilation Syndrome

Condition Hierarchy (Ancestors)

Sleep Apnea, ObstructiveSleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesHypoventilationRespiratory InsufficiencySleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2016

First Posted

October 17, 2016

Study Start

October 29, 2014

Primary Completion

August 12, 2016

Study Completion

October 31, 2018

Last Updated

March 12, 2021

Record last verified: 2016-10

Locations

TW(1)