ADPE: Autonomic Dysfunction in Patients With Pectus Excavatum.

• Sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03346876
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 10

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pectus Excavatum; Autonomic Dysfunction; Surgery	Procedure: Nuss surgery

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 Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 120 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Autonomic Dysfunction in Patients With Pectus Excavatum.
• Actual Study Start Date: Aug 1, 2017
• Anticipated Primary Completion Date: Jul 31, 2018
• Anticipated Study Completion Date: Jul 31, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. The impact of Nuss surgery on HRV in patients with pectus excavatum [6 months]

   If Nuss surgery can improve HRV in different stress in patients with pectus excavatum?

Eligibility Criteria

Criteria

• Ages Eligible for Study: 13 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Taipei Tzu-Chi Hospital, Buddhist Tzu-Chi Medical Foundation	New Taipei		Taiwan	23143

Sponsors and Collaborators

• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
• ClinicalTrials.gov Identifier: NCT03346876
• Other Study ID Numbers: 05-XD-57-110; TCRD-TPE-106-RT-2
• First Posted: Nov 20, 2017
• Last Update Posted: Nov 30, 2017
• Last Verified: Aug 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation: Pectus excavatum, heart rate variability
• Additional relevant MeSH terms: Funnel Chest; Autonomic Nervous System Diseases; Primary Dysautonomias

Study Results

No Results Posted as of Nov 30, 2017