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NCT03346876 Clinical Trial

Autonomic Dysfunction in Patients With Pectus Excavatum.

Surgery Clinical Trial

— ADPE  

Official title:
Autonomic Dysfunction in Patients With Pectus Excavatum.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03346876
Other study ID # 05-XD-57-110
Secondary ID TCRD-TPE-106-RT-
Status Recruiting
Phase N/A
First received November 15, 2017
Last updated November 29, 2017
Start date August 1, 2017
Est. completion date July 31, 2018

Study information
Verified date August 2017
Source Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Contact Mei-Chen Yang, MD
Phone +886-66289779
Email mimimai3461@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Investigators conducted a pilot study to to evaluate the autonomic function in participants with pectus excavatum before and after Nuss surgery.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 120
Est. completion date July 31, 2018
Est. primary completion date July 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 13 Years to 45 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Nuss surgery
surgical correction for pectus excacatum

Locations
Country Name City State
Taiwan Taipei Tzu-Chi Hospital, Buddhist Tzu-Chi Medical Foundation New Taipei

Sponsors (1)
Lead Sponsor Collaborator
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. — View Citation

Tobaldini E, Nobili L, Strada S, Casali KR, Braghiroli A, Montano N. Heart rate variability in normal and pathological sleep. Front Physiol. 2013 Oct 16;4:294. doi: 10.3389/fphys.2013.00294. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary The impact of Nuss surgery on HRV in patients with pectus excavatum If Nuss surgery can improve HRV in different stress in patients with pectus excavatum? 6 months
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