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Mechanisms of Orthopnea in Stable Obese Patients (OBAIRWAY)

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Supine
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Obesity focused on measuring closing volume, expiratory flow limitation, obesity, orthopnea

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • obese (BMI ≥ 30)
  • stable condition
  • 20 < Age < 60 years

Exclusion Criteria:

  • other respiratory disorder (COPD)
  • left cardiac insufficiency

Sites / Locations

  • Hospices civils de lyon, Hôpital de la Croix-Rousse - Réanimation, Surveillance Continue Médicales et Assistance Respiratoire

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

sitting position

supine position

Arm Description

measurement in the sitting position

measurement in the sitting position

Outcomes

Primary Outcome Measures

closing volume by nitrogen washout method

Secondary Outcome Measures

static lung volumes by plethysmography
static lung volumes are composed of vital capacity, FEV1, inspiratory capacity, and reserve expiratory volume and are measured by plethysmography
expiratory flow limitation by NEP test
NEP test

Full Information

First Posted
July 7, 2016
Last Updated
May 23, 2019
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT02832609
Brief Title
Mechanisms of Orthopnea in Stable Obese Patients
Acronym
OBAIRWAY
Official Title
Mechanisms of Orthopnea in Stable Obese Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
closing volume, expiratory flow limitation, obesity, orthopnea

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sitting position
Arm Type
No Intervention
Arm Description
measurement in the sitting position
Arm Title
supine position
Arm Type
Active Comparator
Arm Description
measurement in the sitting position
Intervention Type
Other
Intervention Name(s)
Supine
Intervention Description
measurements after 30 minutes in complete supine position
Primary Outcome Measure Information:
Title
closing volume by nitrogen washout method
Time Frame
30 minutes after changing position (hour 2)
Secondary Outcome Measure Information:
Title
static lung volumes by plethysmography
Description
static lung volumes are composed of vital capacity, FEV1, inspiratory capacity, and reserve expiratory volume and are measured by plethysmography
Time Frame
30 minutes after changing position (hour 2)
Title
expiratory flow limitation by NEP test
Description
NEP test
Time Frame
30 minutes after changing position (hour 2)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: obese (BMI ≥ 30) stable condition 20 < Age < 60 years Exclusion Criteria: other respiratory disorder (COPD) left cardiac insufficiency
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claude Guérin, Prof
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospices civils de lyon, Hôpital de la Croix-Rousse - Réanimation, Surveillance Continue Médicales et Assistance Respiratoire
City
Lyon
ZIP/Postal Code
69004
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
27048626
Citation
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.
Results Reference
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Mechanisms of Orthopnea in Stable Obese Patients

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