Fontan OperationNCT01413308
Pulmonary Functions Test in Patients After Fontan Operation
An observational study of Fontan Operation, run by Rambam Health Care Campus.
Trial summary
Developed in the early 1970s, Fontan Operation has provided palliative care for patients with single ventricle physiology. Single ventricle is a rare subclass of the atrioventricular (AV) alignment abnormalities double inlet and common inlet ventricles (and rarely, straddling tricuspid valve), in which there is only… Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Fontan Operation
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Sep 2011to Sep 2012
- 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: A total number of 15 Fontan patients , aged 10 years and older , with 1-2 NYHA class functional capacity. All will have total pulmonary function tests according to recognized pulmonary protocols. Results will be normalized to age-dependent pulmonogram. Exclusion criteria includes patients with acute pulmonary illness. Generation of Data: 1. Spirometry-Spirometry will be performed in accordance with ATS/ERS (American Thoracic Society/ European Respiratory Society) Task Force 2. Whole Body Plethysmography- FRCpleth will be measured 3. MCT - Methacholine challenge tests will be performed 4. FENO: Measurement of FENO will be performed by portable electrochemical analyzer NIOX MINO (Aerocrine AB, Smidesvägen, Sweden),[10] and according to ATS recommendations .
Who may be able to join
- Fontan patient NYHA 1-2
- Age - 10-99
Who cannot join
- Pregnant woman
- Acute pulmonary disease
About this study
Official title: Long-term Effects on Pulmonary Function in Post- Fontan Operation
Developed in the early 1970s, Fontan Operation has provided palliative care for patients with single ventricle physiology. Single ventricle is a rare subclass of the atrioventricular (AV) alignment abnormalities double inlet and common inlet ventricles (and rarely, straddling tricuspid valve), in which there is only one ventricular sinus [1]. Most patients present with symptoms of congestion , low cardiac output, and deep cyanosis immedietly after birth. Untreated, these heart anomalies are highly lethal. Neonatal heart transplantation is implacable because of shortage of donors. Fontan operation is a three staged palliative procedure: the single ventricle pumping blood to the systemic circulation , while blood flows laminarly to the lungs through direct anastomosis of the superior and inferior vena cavae (total cavo pulmonary connections), inevitably by-passing the right heart .
This procedure has been shown to immediately correct the mixed venous blood dysfunction, providing treatment for the prominent signs of cyanosis.
Read more
Along with its beneficial outcomes, Fontan circulation patients have been documented to have a variety of post-operative late complications. Of most substantial, increased systemic vascular resistance (mean of 10-15 mmHg higher) [2], systolic dysfunction as a result of decreased preload and increase afterload [3], and atrial arrhythmias [4].
With the advent of bypassing right-heart circulation with Fontan operation, the pulmonary vascular bed is exposed to a new atmosphere of blood flow. Instead of physiological pulsatile flow in normal circulation, the pulmonary vasculature is receiving slow velocity, laminar flow [5]. Patients post-Fontan operations have been documented to have restrictive-type pulmonary function, but still yet to be correlated with Fontan circulation or as a possible result of prior lung tissue injury from the pre/intra-operation high volume blood flow. Regardless, Fontan patients are described to have decreased pulmonary function.
The purpose of this research effort is to document and analyze the pulmonary function of those patients post-Fontan operation. It is still unclear as to what the long-term effects of Fontan operation are towards the pulmonary vascular bed, leaving us questions about the effects on lung capacities, ventilation-perfusion efficiency, and oxygen saturation.
Read the detailed description
Generation of Data:
- Spirometry-Spirometry will be performed in accordance with ATS/ERS (American Thoracic Society/ European Respiratory Society) Task Force using a KoKo spirometer (KoKo system, PDS Inc., Ferraris Cardiopulmonary System Group; Louisville, CO, USA). Each maneuver will be repeated for at least three technically acceptable FEFV curves; the best results were used for analysis. [6]
- Whole Body Plethysmography- FRCpleth will be measured in a commercial, whole body ZAN500 constant volume body plethysmograph (ZAN-Messgeraete GmbH, Germany); the surrounded glassed cabin of 980 L includes a chair with adjustable height, all meeting the ATS/ERS recommendations for plethysmography measurements [7,8]. The flow, volume, cabin pressure, and mouth pressures are automatically calibrated. BTPS conditions for lung volumes are automatically corrected. According to the manufacturer, environmental interference is automatically reduced by a numeric-drift-compensation, enabling quick stable signals for immediate testing.
- MCT - Methacholine challenge tests will be performed in a designated room at the Pediatric Pulmonary Unit, Meyer Children's Hospital, Haifa, Israel. MCT was performed with double doses of fresh methacholine solutions in saline. Solutions were driven by KoKo-PDS dosimeter via mouthpiece. The MCT will end when FEV1 dropped by more 20% from baseline FEV1 values or when a methacholine concentration of 16 mg/ml was reached. The exact PC20 value will be then calculated by the program according to the log-transformed formula, as described in the guidelines for methacholine.[9] Airway hyper-reactivity was defined as PC20 <8 mg/ml. Oxygen saturation and heart rate were monitored by pulse oximetry (Nonin Wrist Ox 3100, Nonin Medical, Inc., Plymouth, MN, USA).
- FENO: Measurement of FENO will be performed by portable electrochemical analyzer NIOX MINO (Aerocrine AB, Smidesvägen, Sweden),[10] and according to ATS recommendations . The measurement procedure includes a deep inhalation to total lung capacity followed by exhalation for 10 seconds at a mouth flow rate of 50 mL/sec and a pressure of 10 cmH2O.[11] Analysis of Data: Subjects of study will be patients post-Fontan operation over the age of 6 years in order to fulfill the cooperation requirement necessary to obtain data. Patients should be in general good health without any ongoing acute pulmonary disease.
- Conditions
- Fontan Operation
- Keywords
- Fontan, lung function test, nitric oxide production, NYHA class 1-2 without acute or chronic specified lung disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionMar 2012 (estimated)
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fontan OperationStudies 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Investigators
- Asaad khoury, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01413308
- Sponsor's protocol ID
- 0148CTIL
- Status last verified
- Aug 2011
- First submitted
- 9 Aug 2011
- Last updated
- 10 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Effects on Pulmonary Function in Post- Fontan Operation
- ClinicalTrials.gov ID
- NCT01413308
- Acronym / sponsor ID
- 0148CTIL
- Conditions
- Fontan Operation
- Keywords
- Fontan, lung function test, nitric oxide production, NYHA class 1-2 without acute or chronic specified lung disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 10 Aug 2011 (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.
Developed in the early 1970s, Fontan Operation has provided palliative care for patients with single ventricle physiology. Single ventricle is a rare subclass of the atrioventricular (AV) alignment abnormalities double inlet and common inlet ventricles (and rarely, straddling tricuspid valve), in which there is only one ventricular sinus [1]. Most patients present with symptoms of congestion , low cardiac output, and deep cyanosis immedietly after birth. Untreated, these heart anomalies are highly lethal. Neonatal heart transplantation is implacable because of shortage of donors. Fontan operation is a three staged palliative procedure: the single ventricle pumping blood to the systemic circulation , while blood flows laminarly to the lungs through direct anastomosis of the superior and inferior vena cavae (total cavo pulmonary connections), inevitably by-passing the right heart .
This procedure has been shown to immediately correct the mixed venous blood dysfunction, providing treatment for the prominent signs of cyanosis.
Along with its beneficial outcomes, Fontan circulation patients have been documented to have a variety of post-operative late complications. Of most substantial, increased systemic vascular resistance (mean of 10-15 mmHg higher) [2], systolic dysfunction as a result of decreased preload and increase afterload [3], and atrial arrhythmias [4].
With the advent of bypassing right-heart circulation with Fontan operation, the pulmonary vascular bed is exposed to a new atmosphere of blood flow. Instead of physiological pulsatile flow in normal circulation, the pulmonary vasculature is receiving slow velocity, laminar flow [5]. Patients post-Fontan operations have been documented to have restrictive-type pulmonary function, but still yet to be correlated with Fontan circulation or as a possible result of prior lung tissue injury from the pre/intra-operation high volume blood flow. Regardless, Fontan patients are described to have decreased pulmonary function.
The purpose of this research effort is to document and analyze the pulmonary function of those patients post-Fontan operation. It is still unclear as to what the long-term effects of Fontan operation are towards the pulmonary vascular bed, leaving us questions about the effects on lung capacities, ventilation-perfusion efficiency, and oxygen saturation.
Detailed description
Generation of Data:
- Spirometry-Spirometry will be performed in accordance with ATS/ERS (American Thoracic Society/ European Respiratory Society) Task Force using a KoKo spirometer (KoKo system, PDS Inc., Ferraris Cardiopulmonary System Group; Louisville, CO, USA). Each maneuver will be repeated for at least three technically acceptable FEFV curves; the best results were used for analysis. [6]
- Whole Body Plethysmography- FRCpleth will be measured in a commercial, whole body ZAN500 constant volume body plethysmograph (ZAN-Messgeraete GmbH, Germany); the surrounded glassed cabin of 980 L includes a chair with adjustable height, all meeting the ATS/ERS recommendations for plethysmography measurements [7,8]. The flow, volume, cabin pressure, and mouth pressures are automatically calibrated. BTPS conditions for lung volumes are automatically corrected. According to the manufacturer, environmental interference is automatically reduced by a numeric-drift-compensation, enabling quick stable signals for immediate testing.
- MCT - Methacholine challenge tests will be performed in a designated room at the Pediatric Pulmonary Unit, Meyer Children's Hospital, Haifa, Israel. MCT was performed with double doses of fresh methacholine solutions in saline. Solutions were driven by KoKo-PDS dosimeter via mouthpiece. The MCT will end when FEV1 dropped by more 20% from baseline FEV1 values or when a methacholine concentration of 16 mg/ml was reached. The exact PC20 value will be then calculated by the program according to the log-transformed formula, as described in the guidelines for methacholine.[9] Airway hyper-reactivity was defined as PC20 <8 mg/ml. Oxygen saturation and heart rate were monitored by pulse oximetry (Nonin Wrist Ox 3100, Nonin Medical, Inc., Plymouth, MN, USA).
- FENO: Measurement of FENO will be performed by portable electrochemical analyzer NIOX MINO (Aerocrine AB, Smidesvägen, Sweden),[10] and according to ATS recommendations . The measurement procedure includes a deep inhalation to total lung capacity followed by exhalation for 10 seconds at a mouth flow rate of 50 mL/sec and a pressure of 10 cmH2O.[11] Analysis of Data: Subjects of study will be patients post-Fontan operation over the age of 6 years in order to fulfill the cooperation requirement necessary to obtain data. Patients should be in general good health without any ongoing acute pulmonary disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A total number of 15 Fontan patients , aged 10 years and older , with 1-2 NYHA class functional capacity. All will have total pulmonary function tests according to recognized pulmonary protocols. Results will be normalized to age-dependent pulmonogram. Exclusion criteria includes patients with acute pulmonary illness. Generation of Data: 1. Spirometry-Spirometry will be performed in accordance with ATS/ERS (American Thoracic Society/ European Respiratory Society) Task Force 2. Whole Body Plethysmography- FRCpleth will be measured 3. MCT - Methacholine challenge tests will be performed 4. FENO: Measurement of FENO will be performed by portable electrochemical analyzer NIOX MINO (Aerocrine AB, Smidesvägen, Sweden),[10] and according to ATS recommendations .
Key inclusion criteria (2 listed)
- Fontan patient NYHA 1-2
- Age - 10-99
Key exclusion criteria (2 listed)
- Pregnant woman
- Acute pulmonary disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2011.
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Study of Tadalafil vs. Placebo for Improving Hemodynamics and End-Organ Dysfunction in Fontan Physiology
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Active, not recruitingObservational study
An Observational Study to Learn More About How Safe Rivaroxaban is And How Well it Works in Children With Congenital Heart Disease Who Had a Heart Surgery Called the Fontan Procedure
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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.
Asaad khoury, MD principal investigator
Rambam Health Care Campus
Questions about this trial
What is this clinical trial studying?
An observational study of Fontan Operation, run by Rambam Health Care Campus.
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 2 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 10 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 10 Aug 2011.