NCT04633343

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 11, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 18, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

February 22, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
Last Updated

May 14, 2025

Status Verified

May 1, 2023

Enrollment Period

1.5 years

First QC Date

November 11, 2020

Last Update Submit

May 9, 2025

Conditions

Fontan Physiology

Outcome Measures

Primary Outcomes (1)

  • 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.

    5 minutes of change in Tidal Volume (high vs low)

Secondary Outcomes (2)

  • Blood flow in inferior vena cava (IVC)

    5 minutes of change in Tidal Volume (high vs low)

  • Systemic outflow tract stroke distance (velocity time integral)

    5 minutes of change in Tidal Volume (high vs low)

Study Arms (2)

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

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.

Other: Large volume breath and slow breathing rate for 5 minutes

Interventions

Small volume breath and fast breathing rate for 5 minutesOTHER

Small volume breath and fast breathing rate delivered via mechanical ventilator.

Small Volume Breath Group (5mlKg)
Large volume breath and slow breathing rate for 5 minutesOTHER

Large volume breath and slow breathing rate delivered via mechanical ventilator.

Large Volume Breath Group (10mL/kg)

Eligibility Criteria

Age2 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age 2- 50 years of age
  • Patients with Fontan circulation undergoing cardio-thoracic surgery or undergoing cardio-thoracic surgery for completion of Fontan circulation.

You may not qualify if:

  • \. Patients presenting for cardio-thoracic surgery without Fontan circulation or those not coming for completion of Fontan circulation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (1)

  • 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.

    PMID: 40105302BACKGROUND

Study Officials

  • Manchula Navaratnam, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

November 11, 2020

First Posted

November 18, 2020

Study Start

February 22, 2021

Primary Completion

August 30, 2022

Study Completion

August 30, 2022

Last Updated

May 14, 2025

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)