Mechanisms of Orthopnea in Stable Obese Patients

Obesity Clinical Trial

— OBAIRWAY  

Official title:

Mechanisms of Orthopnea in Stable Obese Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02832609
• Other study ID #: 2009-574
• Status: Completed
• Phase: N/A
• Start date: March 2010
• Est. completion date: October 2013

Study information

• Verified date: July 2016
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• obese (BMI = 30)

• stable condition

• 20 < Age < 60 years

Exclusion Criteria:

• other respiratory disorder (COPD)

• left cardiac insufficiency

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• Supine
measurements after 30 minutes in complete supine position

Locations

Country	Name	City	State
France	Hospices civils de lyon, Hôpital de la Croix-Rousse - Réanimation, Surveillance Continue Médicales et Assistance Respiratoire	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

References & Publications (1)

Perino E, Nesme P, Germain M, Guérin 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	closing volume by nitrogen washout method		30 minutes after changing position (hour 2)
Secondary	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	30 minutes after changing position (hour 2)
Secondary	expiratory flow limitation by NEP test	NEP test	30 minutes after changing position (hour 2)