Fontan PhysiologyNCT04633343
Effects of Different Tidal Volume Ventilation Strategies on Fontan Flow and Hemodynamics
A study testing Small volume breath and fast breathing rate for 5 minutes and Large volume breath and slow breathing rate for 5 minutes in people with Fontan Physiology, run by Stanford University at 1 site in United States.
Trial summary
In patients with Fontan circulation blood is not pumped to the lungs from a ventricle. Instead the superior vena cava and inferior vena cava is connected to the pulmonary artery and blood flow to the lungs occurs passively along this Fontan pathway. Read more about this study
- Who is it for?
- Ages 2 to 50 years
- Conditions the study is for
- Fontan Physiology
- What is being tested?
- Small volume breath and fast breathing rate for 5 minutes and Large volume breath and slow breathing rate for 5 minutes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2021to 30 Aug 2022
- Phase
- Interventional
- 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 2 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 2- 50 years of age
- Patients with Fontan circulation undergoing cardio-thoracic surgery or undergoing cardio-thoracic surgery for completion of Fontan circulation.
Who cannot join
- 1. Patients presenting for cardio-thoracic surgery without Fontan circulation or those not coming for completion of Fontan circulation.
Trial locations and contacts
1 site in 1 country.
About this study
In patients with Fontan circulation blood is not pumped to the lungs from a ventricle. Instead the superior vena cava and inferior vena cava is connected to the pulmonary artery and blood flow to the lungs occurs passively along this Fontan pathway. This passive blood flow to the lungs occurs best when the patient is breathing on their own (spontaneous ventilation). However for certain surgeries and procedures patients need to have an endotracheal tube inserted and need to be muscle relaxed and receive positive pressure ventilation. Prior studies have shown that positive pressure ventilation can reduce blood flow to the lungs and consequently blood returning to the heart resulting in less blood pumped out to the rest of the body (cardiac output). The purpose of this study is to investigate if changing the volume of the positive pressure ventilation (tidal volume) affects blood flow to the lungs and cardiac output in patients with Fontan circulation.
Read the detailed description
If it can be shown that changing the tidal volume does affect the blood flow to the lungs and cardiac output in patients with Fontan circulation the information can be used to learn from this study to optimize the tidal volume ventilation, and therefore pulmonary blood flow and cardiac output when Fontan patients come for general anesthesia. This is important because the population of patients with Fontan circulation is increasing and an increasing number will present for cardiac and non cardiac surgery when positive pressure ventilation will be required. They may also spend time on the cardiac intensive care unit on a ventilator and improving our knowledge on how best to ventilate them may help improve their overall hospital outcomes.
- Conditions
- Fontan Physiology
- Being tested
- Small volume breath and fast breathing rate for 5 minutes, Large volume breath and slow breathing rate for 5 minutes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small volume breath and fast breathing rate for 5 minutesOther
Small volume breath and fast breathing rate delivered via mechanical ventilator.
Large volume breath and slow breathing rate for 5 minutesOther
Large volume breath and slow breathing rate delivered via mechanical ventilator.
| Study group | Role | What they receive |
|---|---|---|
| Small Volume Breath Group (5mlKg) | Experimental | Small volume breath and fast breathing rate for 5 minutes when the patient is in the Operating room and on mechanical ventilation Receives: Other: Small volume breath and fast breathing rate for 5 minutes |
| Large Volume Breath Group (10mL/kg) | Experimental | Large volume breath and slow breathing rate for 5 minutes when the patient is in the Operating room and on mechanical ventilation. Receives: Other: Large volume breath and slow breathing rate for 5 minutes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transpulmonary gradient
Effect of tidal volume changes (high vs low) on Transpulmonary gradient as measured as the difference between mean pulmonary artery pressure measured from right internal jugular (Fontan pressure line) and left atrial pressure measured by direct intracardiac pressure line. Both lines are placed for the scheduled clinical procedure and not solely for the purposes of the research study.
Measured: 5 minutes of change in Tidal Volume (high vs low)
Secondary outcomes (2)
Blood flow in inferior vena cava (IVC)
Effect of tidal volume changes (high vs low) on blood flow in inferior vena cava (IVC) as measured by Transesophageal Echocardiography TEE)..
Measured: 5 minutes of change in Tidal Volume (high vs low)
Systemic outflow tract stroke distance (velocity time integral)
Effect of tidal volume changes (high vs low) on systemic outflow tract stroke distance (velocity time integral) as measured by Transesophageal Echocardiography. (TEE).
Measured: 5 minutes of change in Tidal Volume (high vs low)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start22 Feb 2021
- Primary completion30 Aug 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fontan PhysiologyStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manchula Navaratnam, Stanford University
- Investigators
- Manchula Navaratnam, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04633343
- Sponsor's protocol ID
- 58526
- Status last verified
- May 2023
- First submitted
- 11 Nov 2020
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Navaratnam M, Schmidt AR, Kaplinski M, De Souza E, Beattie MJ, Rowe EV, Punn R, Ramamoorthy C. Hemodynamic Effects of Altering Tidal Volume During Positive Pressure Ventilation in the Fontan Circulation: A Randomized Crossover Trial. Paediatr Anaesth. 2025 Aug;35(8):607-618. doi: 10.1111/pan.15096. Epub 2025 Mar 19.
PubMed 40105302
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Tidal Volume Ventilation Strategies on Fontan Flow and Hemodynamics
- ClinicalTrials.gov ID
- NCT04633343
- Acronym / sponsor ID
- 58526
- Conditions
- Fontan Physiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 18 Nov 2020 (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.
In patients with Fontan circulation blood is not pumped to the lungs from a ventricle. Instead the superior vena cava and inferior vena cava is connected to the pulmonary artery and blood flow to the lungs occurs passively along this Fontan pathway. This passive blood flow to the lungs occurs best when the patient is breathing on their own (spontaneous ventilation). However for certain surgeries and procedures patients need to have an endotracheal tube inserted and need to be muscle relaxed and receive positive pressure ventilation. Prior studies have shown that positive pressure ventilation can reduce blood flow to the lungs and consequently blood returning to the heart resulting in less blood pumped out to the rest of the body (cardiac output). The purpose of this study is to investigate if changing the volume of the positive pressure ventilation (tidal volume) affects blood flow to the lungs and cardiac output in patients with Fontan circulation.
Detailed description
If it can be shown that changing the tidal volume does affect the blood flow to the lungs and cardiac output in patients with Fontan circulation the information can be used to learn from this study to optimize the tidal volume ventilation, and therefore pulmonary blood flow and cardiac output when Fontan patients come for general anesthesia. This is important because the population of patients with Fontan circulation is increasing and an increasing number will present for cardiac and non cardiac surgery when positive pressure ventilation will be required. They may also spend time on the cardiac intensive care unit on a ventilator and improving our knowledge on how best to ventilate them may help improve their overall hospital outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Small Volume Breath Group (5mlKg) | Experimental | Other: Small volume breath and fast breathing rate for 5 minutesSmall volume breath and fast breathing rate for 5 minutes when the patient is in the Operating room and on mechanical ventilation |
| Large Volume Breath Group (10mL/kg) | Experimental | Other: Large volume breath and slow breathing rate for 5 minutesLarge volume breath and slow breathing rate for 5 minutes when the patient is in the Operating room and on mechanical ventilation. |
Who may qualify
- Ages
- 2 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Age 2- 50 years of age
- Patients with Fontan circulation undergoing cardio-thoracic surgery or undergoing cardio-thoracic surgery for completion of Fontan circulation.
Key exclusion criteria (1 listed)
- 1. Patients presenting for cardio-thoracic surgery without Fontan circulation or those not coming for completion of Fontan circulation.
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 |
|---|---|---|
| Small volume breath and fast breathing rate for 5 minutesSmall volume breath and fast breathing rate delivered via mechanical ventilator. | Other | Small Volume Breath Group (5mlKg) |
| Large volume breath and slow breathing rate for 5 minutesLarge volume breath and slow breathing rate delivered via mechanical ventilator. | Other | Large Volume Breath Group (10mL/kg) |
Primary outcome
Transpulmonary gradient
Time frame: 5 minutes of change in Tidal Volume (high vs low)
Effect of tidal volume changes (high vs low) on Transpulmonary gradient as measured as the difference between mean pulmonary artery pressure measured from right internal jugular (Fontan pressure line) and left atrial pressure measured by direct intracardiac pressure line. Both lines are placed for the scheduled clinical procedure and not solely for the purposes of the research study.
2 secondary outcomes
Blood flow in inferior vena cava (IVC)
Time frame: 5 minutes of change in Tidal Volume (high vs low)
Systemic outflow tract stroke distance (velocity time integral)
Time frame: 5 minutes of change in Tidal Volume (high vs low)
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 14 May 2025.
- Results publication: PubMed 40105302Navaratnam M, Schmidt AR, Kaplinski M, De Souza E, Beattie MJ, Rowe EV, Punn R, Ramamoorthy C. Hemodynamic Effects of Altering Tidal Volume During Positive Pressure Ventilation in the Fontan Circulation: A Randomized Crossover Trial. Paediatr Anaesth. 2025 Aug;35(8):607-618. doi: 10.1111/pan.15096. Epub 2025 Mar 19.
- Individual participant dataSharing planned: No
Related trials for Fontan Physiology
Not yet recruitingObservational study
A Simple Method for Monitoring the End-organ Function in Patients With Fontan Circulation.
Fontan Procedure, Fontan Circulation
RecruitingPhase 3
Study of Tadalafil vs. Placebo for Improving Hemodynamics and End-Organ Dysfunction in Fontan Physiology
Fontan Palliation
Recruiting
Venous Compression in Fontan
Single-ventricle, Fontan Circulation
RecruitingObservational study
Blood Based Assessment of sST2, Taken During and After Surgery, for Pediatric Patients With Heart Defects to Predict Heart Failure.
Congenital Heart Surgery, Congenital Heart Disease in Children
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.
Manchula Navaratnam, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Small volume breath and fast breathing rate for 5 minutes and Large volume breath and slow breathing rate for 5 minutes in people with Fontan Physiology, run by Stanford University 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 2 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 14 May 2025. 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?
Transpulmonary gradient (time frame: 5 minutes of change in Tidal Volume (high vs low)). 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 NCT04633343, which also lists 1 linked publication.
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 14 May 2025.