Pulmonary Artery StenosisNCT02586740
Retrospective Review of Anesthetic Considerations for Pulmonary Artery Rehabilitation
An observational study of Pulmonary Artery Stenosis and Tetralogy of Fallot, run by Aymen N Naguib at 1 site in United States.
Trial summary
Pulmonary artery rehabilitation procedure is done frequently in the catheterization suite for patients with pulmonary artery stenosis or small pulmonary arteries following surgical repair for patients with tetralogy of Fallot with pulmonary atresia and major aortopulmonary collaterals. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Artery Stenosis, Tetralogy of Fallot, Pulmonary Atresia
- What is being tested?
- Pulmonary artery rehabilitation
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Oct 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with pulmonary artery stenosis or small pulmonary arteries following surgical repair for tetralogy of Fallot with pulmonary atresia and major aortopulmonary collaterals.
Who may be able to join
- Patients who underwent pulmonary artery angioplasty during the period between October 1st 2010 and October 1st 2015 at NCH.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Pulmonary artery rehabilitation procedure is done frequently in the catheterization suite for patients with pulmonary artery stenosis or small pulmonary arteries following surgical repair for patients with tetralogy of Fallot with pulmonary atresia and major aortopulmonary collaterals. Considering that the investigators' institution is a major center for treating these cases, the investigators wanted to do a retrospective review of the investigators' data to share the investigators' anesthetic management of these procedures.
- Being tested
- Pulmonary artery rehabilitation
- Medical subject headings
- Stenosis, Pulmonary Artery, Tetralogy of Fallot, Pulmonary Atresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary artery rehabilitationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary artery rehabilitation | Patients with pulmonary artery stenosis or small pulmonary arteries following surgical repair for tetralogy of Fallot with pulmonary atresia and major aortopulmonary collaterals undergoing cardiac catheterization. Receives: Procedure: Pulmonary artery rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who experience hemorrhage
Measured: During catheterization procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Artery StenosisStudies 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
- Retrospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aymen N Naguib
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aymen N Naguib, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02586740
- Sponsor's protocol ID
- IRB15-00914
- Status last verified
- Jun 2017
- First submitted
- 23 Oct 2015
- Last updated
- 16 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Review of Anesthetic Considerations for Pulmonary Artery Rehabilitation
- ClinicalTrials.gov ID
- NCT02586740
- Acronym / sponsor ID
- IRB15-00914
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Aymen N NaguibUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 26 Oct 2015 (estimated)
- 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.
Pulmonary artery rehabilitation procedure is done frequently in the catheterization suite for patients with pulmonary artery stenosis or small pulmonary arteries following surgical repair for patients with tetralogy of Fallot with pulmonary atresia and major aortopulmonary collaterals. Considering that the investigators' institution is a major center for treating these cases, the investigators wanted to do a retrospective review of the investigators' data to share the investigators' anesthetic management of these procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulmonary artery rehabilitation | – | Procedure: Pulmonary artery rehabilitationPatients with pulmonary artery stenosis or small pulmonary arteries following surgical repair for tetralogy of Fallot with pulmonary atresia and major aortopulmonary collaterals undergoing cardiac catheterization. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with pulmonary artery stenosis or small pulmonary arteries following surgical repair for tetralogy of Fallot with pulmonary atresia and major aortopulmonary collaterals.
Key inclusion criteria (1 listed)
- Patients who underwent pulmonary artery angioplasty during the period between October 1st 2010 and October 1st 2015 at NCH.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Pulmonary artery rehabilitation | Procedure or surgery | Pulmonary artery rehabilitation |
Primary outcome
Number of patients who experience hemorrhage
Time frame: During catheterization procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pulmonary Artery Stenosis and Tetralogy of Fallot, run by Aymen N Naguib at 1 site in United States.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 16 Jun 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who experience hemorrhage (time frame: During catheterization procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jun 2017.