Mechanisms of Orthopnea in Stable Obese Patients
OBAIRWAY
1 other identifier
interventional
30
1 country
1
Brief Summary
The purpose of this study is to study the role of closing volume as a determinant of orthopnea in stable obese subjects. The investigators hypothesized that: (1) increase in closing volume in supine position would be greater in orthopneic than in non-orthopneic subjects, and (2) the relationship of change in closing volume to change in dyspnea with position would be dependent on expiratory flow limitation in the sitting position. In stable obese subjects, in sitting and supine positions, the investigators measured Borg dyspnea score, static lung volumes, expiratory flow limitation, and single-breath nitrogen expiration test, from which the investigators determined closing volume and closing capacity, slope of phase III, and opening capacity. Orthopnea was defined as any increase in the Borg score in the supine position from its value in the sitting position
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Mar 2010
Typical duration for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 7, 2016
CompletedFirst Posted
Study publicly available on registry
July 14, 2016
CompletedMay 28, 2019
July 1, 2016
3.6 years
July 7, 2016
May 23, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
closing volume by nitrogen washout method
30 minutes after changing position (hour 2)
Secondary Outcomes (2)
static lung volumes by plethysmography
30 minutes after changing position (hour 2)
expiratory flow limitation by NEP test
30 minutes after changing position (hour 2)
Study Arms (2)
sitting position
NO INTERVENTIONmeasurement in the sitting position
supine position
ACTIVE COMPARATORmeasurement in the sitting position
Interventions
Eligibility Criteria
You may qualify if:
- obese (BMI ≥ 30)
- stable condition
- \< Age \< 60 years
You may not qualify if:
- other respiratory disorder (COPD)
- left cardiac insufficiency
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospices civils de lyon, Hôpital de la Croix-Rousse - Réanimation, Surveillance Continue Médicales et Assistance Respiratoire
Lyon, 69004, France
Related Publications (1)
Perino E, Nesme P, Germain M, Guerin C. Mechanisms of Orthopnea in Stable Obese Subjects. Respir Care. 2016 Aug;61(8):1015-22. doi: 10.4187/respcare.04146. Epub 2016 Apr 5.
PMID: 27048626RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Claude Guérin, Prof
Hospices Civils de Lyon
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2016
First Posted
July 14, 2016
Study Start
March 1, 2010
Primary Completion
October 1, 2013
Study Completion
October 1, 2013
Last Updated
May 28, 2019
Record last verified: 2016-07