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
• 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

Related Conditions & MeSH terms

• Autonomic Dysfunction
• Autonomic Nervous System Diseases
• Funnel Chest
• Pectus Excavatum
• Primary Dysautonomias
• Surgery

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