CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
Supine spirometry, MIPs and MEPsother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03347604
NCT03347604N/ACompleted

Effect of Body Position on Spirometry in Abdominal Obesity.

Rush University Medical Center·observational·Posted Nov 20, 2017·Updated Jul 8, 2019

In Brief

An observational study evaluating Supine spirometry, MIPs and MEPs for Obesity, Abdominal. Completed, enrolled 30 participants across 1 site.

Detailed Summary

Objective: Study the effect of body position on spirometry in obese patients as defined by waist to hip ratio (WHR) of greater than 0.85 in women, and 0.9 in men Background: Spirometry is routinely ordered to work up dyspnea in obesity. The most common abnormality is a restrictive disease pattern. The underlying mechanisms of this pattern are not completely understood. One plausible explanation is diaphragmatic weakness or skeletal muscle weakness. The change in forced vital capacity (FVC) from sitting to supine is a very sensitive and specific test for detecting diaphragmatic weakness. The effect of body position on spirometry in obesity has not been extensively studied, and there are no studies that look at this when obesity is measured by waist to hip ratio. Effect of body position has been studied in normal patients, and it is expected the FVC can decrease as much as 10% when changing from sitting to supine. The investigators do not know what would be considered 'the normal' amount for FVC to decrease by in the obese population, and thus would like to test patients with increased WHR both in sitting and supine position. The investigators also want to do muscle strength test by measuring the maximal inspiratory and expiratory pressures (MIPs and MEPs). Anticipated results: the investigators anticipate that our study population will replicate the restrictive disease pattern usually seen in obesity. The investigators also anticipate for the FVC to decrease when in the supine position compared to sitting. The amount by which it decreases will likely fall between 10 -25%. The investigators anticipate to not find any abnormalities in MIPs and MEPs in obesity.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedNov 20, 2017
Enrollment StartOct 6, 2017
Primary CompletionAug 30, 2018
Study CompletionDec 30, 2018
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 8.6 years ago

Interventions

Supine spirometry, MIPs and MEPsother

We are going to test spirometry while in supine position , and also test respiratory muscles by measuring the maximum inspiratory and maximum expiratory efforts made by patients.