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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?
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Vt protocol | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac Output | The investigators will assess cardiac output using the Fink principle for each arm of randomization. | Measurements will occur at the 5-minute equilibration period into the ventilation strategy. |
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary blood flow | The investigators will compare blood flow in both arms. | Measurements will occur at the 5-minute equilibration period into the ventilation strategy. |
| Systemic blood pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Phillip S Adams, DO | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9403618 | Background | 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. | |
| 41277797 | Derived | Adams 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. |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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The trial will be a randomized crossover design.
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Randomized cross over
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| High Vt protocol | Procedure | 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. |
|
The investigators will assess the vital sign in both intervention arms.
| 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. | 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. | 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. | Measurements will occur at the 5-minute equilibration period into the ventilation strategy. |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |