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Autonomic Dysfunction in Patients With Pectus Excavatum.

NCT ID: NCT03346876

Last Updated: 2017-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-01

Study Completion Date

2018-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Pectus Excavatum Autonomic Dysfunction Surgery

Keywords

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Pectus excavatum, heart rate variability

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Study group

patients with pectus excavatum

Nuss surgery

Intervention Type PROCEDURE

surgical correction for pectus excacatum

Control group

healthy subjects without pectus excavatum

No interventions assigned to this group

Interventions

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Nuss surgery

surgical correction for pectus excacatum

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mei-Chen Yang, MD

Role: STUDY_CHAIR

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Locations

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

New Taipei City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Mei-Chen Yang, MD

Role: CONTACT

Phone: +886-66289779

Email: [email protected]

Facility Contacts

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Mei-Chen Yang, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 8598068 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24137133 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35505418 (View on PubMed)

Other Identifiers

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TCRD-TPE-106-RT-2

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

05-XD-57-110

Identifier Type: -

Identifier Source: org_study_id