Effects Oxygen Supplementation Determined Better Exercise Capacity in Eisenmenger Syndrome

Not Applicable

Completed

• Conditions: Eisenmenger Complex; Hypertension, Pulmonary
• Interventions: Other: Oxygen Supplementation

• Registration Number: NCT02661802
• Lead Sponsor: Federal University of São Paulo

Brief Summary

The purpose of this study was to evaluate the acute effects of oxygen supplementation during a submaximal exercise test in patients with Eisenmenger's Syndrome.

Detailed Description

Patients with Eisenmenger's syndrome were submitted to a submaximal exercise test (six-minute walking test) with and without supplemental oxygen. The distance walked during the two tests were compared to assess the impact of oxygen supplementation on the walking distance.

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2016-01
• Study First Submitted: 2016-01-20
• Study First Submitted QC: 2016-01-21
• Study First Posted: 2016-01-22
• Last Update Submitted: 2016-01-22
• Last Update Posted: 2016-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Abscence of heart failure and/or respiratory infection
• Advanced therapy for pulmonary hypertension

Exclusion Criteria

• Lung, liver or connective tissue diseases
• Neuromuscular diseases
• Inability to perform a pulmonary function test and/or chronic lung disease
• Inability to walk

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oxygen Supplementation	Oxygen Supplementation	Two six-minute walk tests, one with oxygen supplementation and another without were performed on different days. During the test with oxygen supplementation the delivery was continuous by mask at 40% and technician walked behind the patient with the oxygen source.

Primary Outcome Measures

Name	Time	Method
Distance walked during the six-minute walk tests	At enrollment	Distance walked during the six-minute walk tests with and without oxygen supplementation were recorded and compared to each other to establish the impact of the intervention.