Effects Oxygen Supplementation Determined Better Exercise Capacity in Eisenmenger Syndrome

NCT ID: NCT02661802

Last Updated: 2016-01-25

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

2012-01-31

Study Completion Date

2014-06-30

Brief Summary

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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

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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.

Conditions

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Eisenmenger Complex Hypertension, Pulmonary

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Oxygen Supplementation

Intervention Type OTHER

Oxygen delivery was continuous by mask at 40%

Interventions

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Oxygen Supplementation

Oxygen delivery was continuous by mask at 40%

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Laion rodrigo do Amaral Gonzaga

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Laion Gonzaga, PT

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Other Identifiers

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13473813.1.0000.5505

Identifier Type: -

Identifier Source: org_study_id

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