AnesthesiaNCT04672538
Fontan Physiology Ventilation Strategy
A study testing Low Vt protocol and High Vt protocol in people with Anesthesia and Congenital Heart Disease, run by University of Pittsburgh at 1 site in United States.
Trial summary
This study will investigate the different tidal volume (Vt) strategies during a cardiac catheterization procedure to determine whether or not low or high Vt have an impact on cardiac output. Research question: While maintaining the same minute ventilation/PaCO2, does higher Vt (10 cc/kg)/lower rate vs. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anesthesia, Congenital Heart Disease
- What is being tested?
- Low Vt protocol and High Vt protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2021to 15 May 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients of UPMC Children's Hospital of Pittsburgh that have Fontan physiology (single heart ventricle) that are presenting as outpatients to undergo a cardiac catheterization with general endotracheal anesthesia for purpose of diagnosis or interventional cath.
- Parents and/or guardians willing to provide informed consent.
Who cannot join
- Those unwilling to give consent and those patients who do not have Fontan physiology.
- Any urgent/emergent catheterization procedure will be excluded.
- Any Fontan patient having a cardiac catheterization under monitored anesthesia care (as opposed to general endotracheal anesthesia) will not be eligible.
- Inability to undergo cardiac catheterization.
- Pregnant women will be excluded.
- < 6 weeks post-op from Fontan completion surgery
Show all 9Show fewer
- Same hospitalization as Fontan completion surgery
- Intrinsic pulmonary disease which would be anticipated to impact study protocol / findings
- Fontan completion surgery performed at age > 7 years
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
About this study
Official title: Impact of Fontan Ventilation Strategy on Cardiac Output: An Invasive Physiologic Cross-over Study
This study will investigate the different tidal volume (Vt) strategies during a cardiac catheterization procedure to determine whether or not low or high Vt have an impact on cardiac output.
Research question: While maintaining the same minute ventilation/PaCO2, does higher Vt (10 cc/kg)/lower rate vs. lower Vt (6 cc/kg)/higher rate (maintaining consistent PEEP) result in improved cardiac output?
Read the detailed description
The trial will be a randomized crossover design. The study cohort will be randomized (50/50) to begin with either low Vt or high Vt ventilation. After achieving steady state, initial cardiac output measurements will be made using a measured oxygen consumption (VO2) and the Fick principle, per routine clinical protocol. Following baseline assessment of cardiac output and hemodynamics (which is standard of care for all catheterization procedures), participants will be transitioned to the alternative ventilation modality (high Vt or low Vt). After a 5-minute equilibration period, oxygen saturations and VO2 measurements will be re-acquired, to determine cardiac output and hemodynamics in this second state.
- Conditions
- Anesthesia, Congenital Heart Disease
- Being tested
- Low Vt protocol, High Vt protocol
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Vt protocolProcedure or surgery
Low Vt protocol - tidal volumes (Vt) 6 ml/kg, respiratory rate required for end tidal carbon dioxide (EtCO2) of 36-38 mmHg, PEEP 5 centimeter of water (cm-H20) , I:E ratio 1:2
High Vt protocolProcedure or surgery
High Vt protocol - tidal volumes (Vt) 10 ml/kg, respiratory rate required for EtCO2 of 36-38 mm Hg, PEEP 5 cmH2O, I:E ratio 1:3.
| Study group | Role | What they receive |
|---|---|---|
| Low transition to High Vt protocol | Experimental | This arm of the study will begin with lower tidal volumes at higher respiratory rates for initial hemodynamic measurements. They will then be transitioned to the higher tidal volume at lower respiratory rate condition for repeat hemodynamic measurement. Receives: Procedure: Low Vt protocol; Procedure: High Vt protocol |
| High transition to Low Vt protocol | Experimental | This arm of the study will begin with higher tidal volumes at lower respiratory rates for initial hemodynamic measurements. They will then be transitioned to the lower tidal volume at higher respiratory rate condition for repeat hemodynamic measurement. Receives: Procedure: Low Vt protocol; Procedure: High Vt protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Output
The investigators will assess cardiac output using the Fink principle for each arm of randomization.
Measured: Measurements will occur at the 5-minute equilibration period into the ventilation strategy.
Secondary outcomes (5)
Pulmonary blood flow
The investigators will compare blood flow in both arms.
Measured: Measurements will occur at the 5-minute equilibration period into the ventilation strategy.
Systemic blood pressure
The investigators will assess the vital sign in both intervention arms.
Measured: Measurements will occur at the 5-minute equilibration period into the ventilation strategy.
Pulmonary arterial pressure
The investigators will assess pressures in both intervention arms.
Measured: Measurements will occur at the 5-minute equilibration period into the ventilation strategy.
Pulmonary vascular resistance
Completed using pulmonary vascular resistance (PVR) equation from measurements obtained during the cardiac catheterization.
Measured: Measurements will occur at the 5-minute equilibration period into the ventilation strategy.
Systemic vascular resistance
This will be calculated using appropriate equations using measurement obtained during catheterization procedure.
Measured: Measurements will occur at the 5-minute equilibration period into the ventilation strategy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start2 Mar 2021
- Primary completion14 Mar 2023
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The trial will be a randomized crossover design.
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Phillip S. Adams, DO, University of Pittsburgh
- Investigators
- Phillip S Adams, DO, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04672538
- Sponsor's protocol ID
- STUDY20100012
- Status last verified
- May 2023
- First submitted
- 8 Dec 2020
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shekerdemian LS, Bush A, Shore DF, Lincoln C, Redington AN. Cardiopulmonary interactions after Fontan operations: augmentation of cardiac output using negative pressure ventilation. Circulation. 1997 Dec 2;96(11):3934-42. doi: 10.1161/01.cir.96.11.3934.
PubMed 9403618Adams PS, Stollings LM, Bains S, Blasiole B, Nguyen KN, Phadke AS, Callahan PM, Trucco SM, Kreutzer J, Goldstein BH. Comparing Cardiac Output Differences in Patients With Fontan Physiology Between High and Low Tidal Volume Strategies: A Randomized, Crossover Trial. Paediatr Anaesth. 2026 Feb;36(2):187-193. doi: 10.1111/pan.70085. Epub 2025 Nov 24.
PubMed 41277797
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Fontan Ventilation Strategy on Cardiac Output: An Invasive Physiologic Cross-over Study
- ClinicalTrials.gov ID
- NCT04672538
- Acronym / sponsor ID
- STUDY20100012
- Conditions
- Anesthesia, Congenital Heart Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 2 Mar 2021 (actual)
- Primary completion
- 14 Mar 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 17 Dec 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.
This study will investigate the different tidal volume (Vt) strategies during a cardiac catheterization procedure to determine whether or not low or high Vt have an impact on cardiac output.
Research question: While maintaining the same minute ventilation/PaCO2, does higher Vt (10 cc/kg)/lower rate vs. lower Vt (6 cc/kg)/higher rate (maintaining consistent PEEP) result in improved cardiac output?
Detailed description
The trial will be a randomized crossover design. The study cohort will be randomized (50/50) to begin with either low Vt or high Vt ventilation. After achieving steady state, initial cardiac output measurements will be made using a measured oxygen consumption (VO2) and the Fick principle, per routine clinical protocol. Following baseline assessment of cardiac output and hemodynamics (which is standard of care for all catheterization procedures), participants will be transitioned to the alternative ventilation modality (high Vt or low Vt). After a 5-minute equilibration period, oxygen saturations and VO2 measurements will be re-acquired, to determine cardiac output and hemodynamics in this second state.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The trial will be a randomized crossover design.
| Arm | Type | Receives |
|---|---|---|
| Low transition to High Vt protocol | Experimental | Procedure: Low Vt protocol, Procedure: High Vt protocolThis arm of the study will begin with lower tidal volumes at higher respiratory rates for initial hemodynamic measurements. They will then be transitioned to the higher tidal volume at lower respiratory rate condition for repeat hemodynamic measurement. |
| High transition to Low Vt protocol | Experimental | Procedure: Low Vt protocol, Procedure: High Vt protocolThis arm of the study will begin with higher tidal volumes at lower respiratory rates for initial hemodynamic measurements. They will then be transitioned to the lower tidal volume at higher respiratory rate condition for repeat hemodynamic measurement. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients of UPMC Children's Hospital of Pittsburgh that have Fontan physiology (single heart ventricle) that are presenting as outpatients to undergo a cardiac catheterization with general endotracheal anesthesia for purpose of diagnosis or interventional cath.
- Parents and/or guardians willing to provide informed consent.
Key exclusion criteria (9 listed)
- Those unwilling to give consent and those patients who do not have Fontan physiology.
- Any urgent/emergent catheterization procedure will be excluded.
- Any Fontan patient having a cardiac catheterization under monitored anesthesia care (as opposed to general endotracheal anesthesia) will not be eligible.
- Inability to undergo cardiac catheterization.
- Pregnant women will be excluded.
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 |
|---|---|---|
| Low Vt protocolLow Vt protocol - tidal volumes (Vt) 6 ml/kg, respiratory rate required for end tidal carbon dioxide (EtCO2) of 36-38 mmHg, PEEP 5 centimeter of water (cm-H20) , I:E ratio 1:2 | Procedure or surgery | High transition to Low Vt protocol, Low transition to High Vt protocol |
| High Vt protocolHigh Vt protocol - tidal volumes (Vt) 10 ml/kg, respiratory rate required for EtCO2 of 36-38 mm Hg, PEEP 5 cmH2O, I:E ratio 1:3. | Procedure or surgery | High transition to Low Vt protocol, Low transition to High Vt protocol |
Primary outcome
Cardiac Output
Time frame: Measurements will occur at the 5-minute equilibration period into the ventilation strategy.
The investigators will assess cardiac output using the Fink principle for each arm of randomization.
5 secondary outcomes
Pulmonary blood flow
Time frame: Measurements will occur at the 5-minute equilibration period into the ventilation strategy.
Systemic blood pressure
Time frame: Measurements will occur at the 5-minute equilibration period into the ventilation strategy.
Pulmonary arterial pressure
Time frame: Measurements will occur at the 5-minute equilibration period into the ventilation strategy.
Pulmonary vascular resistance
Time frame: Measurements will occur at the 5-minute equilibration period into the ventilation strategy.
Systemic vascular resistance
Time frame: Measurements will occur at the 5-minute equilibration period into the ventilation strategy.
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 17 May 2023.
- Background: PubMed 9403618Shekerdemian LS, Bush A, Shore DF, Lincoln C, Redington AN. Cardiopulmonary interactions after Fontan operations: augmentation of cardiac output using negative pressure ventilation. Circulation. 1997 Dec 2;96(11):3934-42. doi: 10.1161/01.cir.96.11.3934.
- Derived from this study: PubMed 41277797Adams PS, Stollings LM, Bains S, Blasiole B, Nguyen KN, Phadke AS, Callahan PM, Trucco SM, Kreutzer J, Goldstein BH. Comparing Cardiac Output Differences in Patients With Fontan Physiology Between High and Low Tidal Volume Strategies: A Randomized, Crossover Trial. Paediatr Anaesth. 2026 Feb;36(2):187-193. doi: 10.1111/pan.70085. Epub 2025 Nov 24.
- 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.
Phillip S Adams, DO principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Vt protocol and High Vt protocol in people with Anesthesia and Congenital Heart Disease, run by University of Pittsburgh 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 9 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 17 May 2023. 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?
Cardiac Output (time frame: Measurements will occur at the 5-minute equilibration period into the ventilation strategy.). 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 NCT04672538, which also lists 2 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 17 May 2023.