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NCT04633343 · ClinicalTrials.gov registry record · NA
Effects of Different Tidal Volume Ventilation Strategies on Fontan Flow and Hemodynamics
A NA study, sponsored by Stanford University.
- Completed
- Registry status
- NA
- Development phase
- 12
- Enrollment target
NCT04633343: Completed NA study, sponsored by Stanford University.
NCT04633343 is a NA study that has completed, run by Stanford University. The registered enrollment target is 12 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04633343, a NA study, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
Study 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. 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.
Primary Outcome
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.
Interventions
- OTHER Small volume breath and fast breathing rate for 5 minutes
- OTHER Large volume breath and slow breathing rate for 5 minutes
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2021-02-22 |
| Est. Completion | 2022-08-30 |
| Phase | NA |
What the finished NCT04633343 record still lists
NCT04633343 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Small volume breath and fast breathing rate for 5 minutes is the first listed.
NCT04633343 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04633343 about?
NCT04633343 is a clinical study titled "Effects of Different Tidal Volume Ventilation Strategies on Fontan Flow and Hemodynamics". 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 w...
What is the current status of trial NCT04633343?
This trial is currently completed. It is a NA study. The enrollment target is 12 participants. The study started on 2021-02-22. Estimated completion is 2022-08-30.
What interventions are being tested in trial NCT04633343?
The interventions under investigation include: Small volume breath and fast breathing rate for 5 minutes (OTHER), Large volume breath and slow breathing rate for 5 minutes (OTHER).
Who is sponsoring clinical trial NCT04633343?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04633343's enrollment target sits among peer trials
12 1913th of 2000 higher than 74 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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