Functional Capacity and Quality of Life in Patients With Vascular Ring

• Conditions: Vascular Ring
• Interventions: Diagnostic Test: Cardiopulmonary exercise test

• Registration Number: NCT04781738
• Lead Sponsor: Rambam Health Care Campus

Brief Summary

To investigate the long term functional capacity and quality of life of patients with a history of vascular ring whether they did or did not have corrective surgery. Patients will perform pulmonary function test, 6 minute walk test, cardiopulmonary exercise test and will fill a quality of life questionnaire.

Detailed Description

Vascular rings are congenital vascular anomalies of the aortic arch that compress the esophagus and the trachea. The most common vascular rings are double aortic arch and right aortic arch with left ligamentum. Pulmonary artery sling is less common. Another cause of tracheal compression occurring only in infants is the innominate artery compression syndrome. When patients are symptomatic, surgical correction should be performed.

data regarding long term functional capacity and quality of life is lacking. our aim is to investigate the long term functional capacity and quality of life of patients with history of vascular ring whether they did or did not have corrective surgery.

Methods: a prospective study evaluating functional capacity and quality of life the patients will perform pulmonary function test, 6 minute walk test, cardiopulmonary exercise test and will fill a quality of life questionnaire (sf-36).

Study Timeline

• Study Start: 2018-03-15
• Status Verified: 2021-02
• Study First Submitted: 2021-02-21
• Study First Submitted QC: 2021-02-28
• Last Update Submitted: 2021-02-28
• Study First Posted: 2021-03-04
• Last Update Posted: 2021-03-04
• Primary Completion: 2021-12
• Study Completion: 2022-02

Recruitment & Eligibility

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

Inclusion Criteria

• patients with history of vascular ring

Exclusion Criteria

• refusal to participate
• inability to complete cardiopulmonary testing

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with history of vascular ring who didn't have corrective surgery	Cardiopulmonary exercise test	patients with history of vascular ring who didn't have corrective surgery
patients with history of vascular ring who underwent corrective surgery	Cardiopulmonary exercise test	patients with history of vascular ring who underwent corrective surgery

Primary Outcome Measures

Name	Time	Method
Exercise capacity	Measured continuously during 15 minutes of the exercise test (CPET)	Oxygen uptake evaluated by cardiopulmonary exercise testing (CPET)

Secondary Outcome Measures

Name	Time	Method
Six minute walk test	Six minutes of evaluation, completed pre cardiopulmonary exercise test (CPET)	The distance gained after six minute of habitual walking.
Quality of life - SF-36	Five minutes of evaluation, completed pre cardiopulmonary exercise test (CPET)	The calculated result of SF-36 questionnaire

Trial Locations

Locations (1)

Rambam health care campus; 🇮🇱 Haifa, Israel