Pectus ExcavatumADPENCT03346876
Autonomic Dysfunction in Patients With Pectus Excavatum.
An observational study of Pectus Excavatum and Autonomic Dysfunction, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation at 1 site in Taiwan.
Trial summary
Investigators conducted a pilot study to to evaluate the autonomic function in participants with pectus excavatum before and after Nuss surgery. Read more about this study
- Who is it for?
- Ages 13 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pectus Excavatum, Autonomic Dysfunction, Surgery
- What is being tested?
- Nuss surgery
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2017to 31 Jul 2018
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: 13~45 y/o pectus patients and healthy subjects
Who may be able to join
- Clinical diagnosis of pectus excavatum
- Agree to receive Nuss surgery to correct pectus excavatum
Who cannot join
- Major medical disease (asthma, heart failure, renal disease)
- Known psychiatric disease
- Known sleep-disordered breathing
- Skeletal disease
- Major surgery within 6 months
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Tzu-Chi Hospital, Buddhist Tzu-Chi Medical Foundation
New Taipei City, 23143
Mei-Chen Yang, MD, +886-66289779 ext. 5709, mimimai3461@gmail.com
About this study
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.
- Conditions
- Pectus Excavatum, Autonomic Dysfunction, Surgery
- Being tested
- Nuss surgery
- Keywords
- Pectus excavatum, heart rate variability
- Medical subject headings
- Funnel Chest, Primary Dysautonomias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nuss surgeryProcedure or surgery
surgical correction for pectus excacatum
| Study group | Role | What they receive |
|---|---|---|
| Study group | patients with pectus excavatum Receives: Procedure: Nuss surgery | |
| Control group | healthy subjects without pectus excavatum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start1 Aug 2017
- Primary completion31 Jul 2018 (estimated)
- Study completion31 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pectus ExcavatumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mei-Chen Yang, MD, Study chair, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03346876
- Sponsor's protocol ID
- 05-XD-57-110
- Other IDs
- TCRD-TPE-106-RT-2
- Acronym
- ADPE
- Status last verified
- Aug 2017
- First submitted
- 15 Nov 2017
- Last updated
- 30 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 8598068Tobaldini 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 24137133Hsu 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autonomic Dysfunction in Patients With Pectus Excavatum.
- ClinicalTrials.gov ID
- NCT03346876
- Acronym / sponsor ID
- ADPE / 05-XD-57-110
- Conditions
- Pectus Excavatum, Autonomic Dysfunction, Surgery
- Keywords
- Pectus excavatum, heart rate variability
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 31 Jul 2018 (estimated)
- Study completion
- 31 Jul 2018 (estimated)
- First posted
- 20 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigators conducted a pilot study to to evaluate the autonomic function in participants with pectus excavatum before and after 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Procedure: Nuss surgerypatients with pectus excavatum |
| Control group | – | –healthy subjects without pectus excavatum |
Who may qualify
- Ages
- 13 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 13~45 y/o pectus patients and healthy subjects
Key inclusion criteria (2 listed)
- Clinical diagnosis of pectus excavatum
- Agree to receive Nuss surgery to correct pectus excavatum
Key exclusion criteria (5 listed)
- Major medical disease (asthma, heart failure, renal disease)
- Known psychiatric disease
- Known sleep-disordered breathing
- Skeletal disease
- Major surgery within 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nuss surgerysurgical correction for pectus excacatum | Procedure or surgery | Study group |
Primary outcome
The impact of Nuss surgery on HRV in patients with pectus excavatum
Time frame: 6 months
If Nuss surgery can improve HRV in different stress in patients with pectus excavatum?
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2017.
- Background: PubMed 8598068Heart 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.
- Background: PubMed 24137133Tobaldini 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.
- Derived from this study: PubMed 35505418Hsu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mei-Chen Yang, MD study chair
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pectus Excavatum and Autonomic Dysfunction, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mei-Chen Yang, MD (+886-66289779 ext. 5709, mimimai3461@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The impact of Nuss surgery on HRV in patients with pectus excavatum (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03346876, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2017.