Mechanisms of Orthopnea in Stable Obese Patients

NCT ID: NCT02832609

Last Updated: 2019-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2013-10-31

Brief Summary

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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

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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sitting position

measurement in the sitting position

Group Type NO_INTERVENTION

No interventions assigned to this group

supine position

measurement in the sitting position

Group Type ACTIVE_COMPARATOR

Supine

Intervention Type OTHER

measurements after 30 minutes in complete supine position

Interventions

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Supine

measurements after 30 minutes in complete supine position

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* other respiratory disorder (COPD)
* left cardiac insufficiency
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Claude Guérin, Prof

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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

Lyon, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 27048626 (View on PubMed)

Other Identifiers

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2009-574

Identifier Type: -

Identifier Source: org_study_id

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