Autonomic Dysfunction in Patients With Pectus Excavatum.

NCT03346876 | Unknown DMC

• 2 other identifiers: 05-XD-57-110TCRD-TPE-106-RT-2
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pectus Excavatum; Autonomic Dysfunction; Surgery

Keywords

Pectus excavatum, heart rate variability

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Study group

patients with pectus excavatum

Procedure: Nuss surgery

Control group

healthy subjects without pectus excavatum

Interventions

Nuss surgery PROCEDURE

surgical correction for pectus excacatum

Study group

Eligibility Criteria

• Age: 13 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

13\~45 y/o pectus patients and healthy subjects

You may qualify if:

• Clinical diagnosis of pectus excavatum
• Agree to receive Nuss surgery to correct pectus excavatum

You may not qualify if:

• Major medical disease (asthma, heart failure, renal disease)
• Known psychiatric disease
• Known sleep-disordered breathing
• Skeletal disease
• Major surgery within 6 months

Sponsors & Collaborators

• Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation: lead

Study Sites (1)

Taipei Tzu-Chi Hospital, Buddhist Tzu-Chi Medical Foundation

New Taipei City, 23143, Taiwan

RECRUITING

Related Publications (3)

• 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. No abstract available.

  PMID: 8598068 BACKGROUND

• 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.

  PMID: 24137133 BACKGROUND

• Hsu YT, Cheng YL, Chang YW, Lan CC, Wu YK, Yang MC. Autonomic nervous system dysregulation in response to postural change in patients with pectus excavatum in Taiwan: a pilot study. J Cardiothorac Surg. 2022 May 3;17(1):89. doi: 10.1186/s13019-022-01835-5.

  PMID: 35505418 DERIVED

MeSH Terms

Conditions

Funnel Chest; Primary Dysautonomias

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Autonomic Nervous System Diseases; Nervous System Diseases

Study Officials

• Mei-Chen Yang, MD

  Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

  STUDY CHAIR

Central Study Contacts

Mei-Chen Yang, MD

CONTACT

+886-66289779; mimimai3461@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2017
• First Posted: November 20, 2017
• Study Start: August 1, 2017
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2018
• Last Updated: November 30, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)