Cardiopulmonary Effect of Mechanical Ventilation in Children With Right Ventricular Hypertrophy

Summary

Neurally adjusted ventilatory assist (NAVA) is a new mode of mechanical ventilation that delivers ventilatory assist in proportion to neural effort. The investigators hope to compare the hemodynamic and pulmonary effect in children after surgical repair of congenital heart disease with right ventricular hypertrophic ventilated with Pressure control ventilation (PCV), Pressure support ventilation (PSV), and NAVA by a crossover study.

Conditions

• Heart-lung Interaction
• Right Ventricular Hypertrophy
• Postoperative Care
• Congenital Heart Disease
• Mechanical Ventilation

Interventions

DEVICE

Mechanical ventilation with NAVA mode

To compare the hemodynamic and pulmonary effect in patients after surgical repair with right ventricular hypertrophic ventilated with PCV, PSV and NAVA by a crossover study. Each patient will undergo three 60-min trials during the study period in randomized order. The cardiac output and volume status will be evaluated by a transpulmonary thermodilution device through a pulse contour cardiac output (PiCCO) catheter at the last 10min of each trial. At the mean while an arterial blood gas and echocardiography will perform.

DEVICE

Mechanical ventilation with PCV mode

To compare the hemodynamic and pulmonary effect in patients after surgical repair with right ventricular hypertrophic ventilated with PCV, PSV and NAVA by a crossover study. Each patient will undergo three 60-min trials during the study period in randomized order. The cardiac output and volume status will be evaluated by a transpulmonary thermodilution device through a pulse contour cardiac output (PiCCO) catheter at the last 10min of each trial. At the mean while an arterial blood gas and echocardiography will perform.

DEVICE

Mechanical ventilation with PSV mode

To compare the hemodynamic and pulmonary effect in patients after surgical repair with right ventricular hypertrophic ventilated with PCV, PSV and NAVA by a crossover study. Each patient will undergo three 60-min trials during the study period in randomized order. The cardiac output and volume status will be evaluated by a transpulmonary thermodilution device through a pulse contour cardiac output (PiCCO) catheter at the last 10min of each trial. At the mean while an arterial blood gas and echocardiography will perform.

Sponsors & Collaborators

• Limin Zhu

  lead OTHER

Principal Investigators

• Limin Zhu, M.D. · Shanghai Children/s Medical Center, Shanghai Jiaotong University School of Medicine

• Xiaolei Gong, M.D. · Shanghai Children/s Medical Center, Shanghai Jiaotong University School of Medicine

• Zhuoming Xu, Ph. D & M.D. · Shanghai Children/s Medical Center, Shanghai Jiaotong University School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

3 Months

Max Age

3 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-02-25

Primary Completion

2021-02-28

Completion

2021-12-31

Countries

• China

Study Locations