Autonomic Dysfunction in Patients With Pectus Excavatum. (ADPE)

November 29, 2017 updated by: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Investigators conducted a pilot study to to evaluate the autonomic function in participants with pectus excavatum before and after Nuss surgery.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Since pectus excavatum can cause cardiac arrhythmia, the cardiac autonomic function in participants with pectus excavatum might be impaired. However, to our knowledge, there is no any study to evaluate the cardiac autonomic function in participants with pectus excavatum.

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • New Taipei, Taiwan, 23143
        • Recruiting
        • Taipei Tzu-Chi Hospital, Buddhist Tzu-Chi Medical Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

13~45 y/o pectus patients and healthy subjects

Description

Inclusion Criteria:

  1. Clinical diagnosis of pectus excavatum
  2. Agree to receive Nuss surgery to correct pectus excavatum

Exclusion criteria:

  1. Major medical disease (asthma, heart failure, renal disease)
  2. Known psychiatric disease
  3. Known sleep-disordered breathing
  4. Skeletal disease
  5. Major surgery within 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study group
patients with pectus excavatum
Procedure: Nuss surgery
surgical correction for pectus excacatum
Control group
healthy subjects without pectus excavatum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The impact of Nuss surgery on HRV in patients with pectus excavatum
Time Frame: 6 months
If Nuss surgery can improve HRV in different stress in patients with pectus excavatum?
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Investigators

  • Study Chair: Mei-Chen Yang, MD, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2017

Primary Completion (Anticipated)

July 31, 2018

Study Completion (Anticipated)

July 31, 2018

Study Registration Dates

First Submitted

November 15, 2017

First Submitted That Met QC Criteria

November 15, 2017

First Posted (Actual)

November 20, 2017

Study Record Updates

Last Update Posted (Actual)

November 30, 2017

Last Update Submitted That Met QC Criteria

November 29, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-XD-57-110
  • TCRD-TPE-106-RT-2 (Other Grant/Funding Number: Taipei Tzu-Chi Hospital, Buddhist Tzu-Chi Medical Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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