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Status unknownNCT03346876ADPEUpdated Nov 30, 2017

Autonomic Dysfunction in Patients With Pectus Excavatum.

An observational study in Pectus Excavatum, Autonomic Dysfunction and Surgery, sponsored by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation. Status unknown at 1 site in Taiwan. Open to participants aged 13 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-30.

Sponsored by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation · Observational

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Ages
13 Years to 45 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Pectus Excavatum
  • Autonomic Dysfunction
  • Surgery

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Keywords

  • Pectus excavatum, heart rate variability
03

In context

Funnel Chest

79 studies on the registry are indexed under Funnel Chest; 10 are open to participants now.

This study's planned enrollment of 120 is above the median of 68 across 32 observational studies indexed under Funnel Chest.

Browse Funnel Chest studies →

Lead sponsor

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation is the lead sponsor of 58 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Clinical diagnosis of pectus excavatum
  2. Agree to receive Nuss surgery to correct pectus excavatum

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (estimated)
Target follow-up
6 Months
Patient registry
Yes

Groups and cohorts

  • Study group

    patients with pectus excavatum

    Procedure: Nuss surgery

  • Control group

    healthy subjects without pectus excavatum

Interventions

  • ProcedureNuss surgery

    surgical correction for pectus excacatum

06

What researchers measure

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?

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • Taipei Tzu-Chi Hospital, Buddhist Tzu-Chi Medical Foundation
    New Taipei, 23143, Taiwan
    Recruiting
08

References and documents

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. No abstract available. PubMed 8598068 ↗
  • 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. PubMed 24137133 ↗
  • 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. PubMed 35505418 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Aug 2017 (actual). Primary completion is estimated for Jul 2018, 11 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 15, 2017
First posted
Nov 20, 2017
StartActual
Aug 1, 2017
Primary completionEst.
Jul 31, 2018
CompletionEst.
Jul 31, 2018
Last update
Nov 30, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 30, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03346876
Lead sponsor
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Responsible party
Sponsor
First posted
Nov 20, 2017
Start date
Aug 1, 2017
Primary completion
Jul 31, 2018 (estimated)
Completion
Jul 31, 2018 (estimated)
Last update
Nov 30, 2017

Study contacts

Mei-Chen Yang, MD
Contact
mimimai3461@gmail.com
+886-66289779 ext. 5709
Mei-Chen Yang, MD
study chair · Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

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