Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Congenital Heart Disease
  • Heart - Lung Interaction
  • Mechanical Ventilation
  • Postoperative Care
  • Right Ventricular Hypertrophy
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: pressure control ventilation pressure support ventilation neurally adjusted ventilatory assist Masking: Single (Participant)Primary Purpose: Supportive Care

Participation Requirements

Age
Younger than 33 years
Gender
Both males and females

Description

In the patients suffered from congenital heart disease with right ventricular hypertrophy, the preload of the heart will be influenced by the variation of the intrathoracic pressure. The cardiopulmonary interaction during mechanical ventilation will be an important influence factor on hemodynamics a...

In the patients suffered from congenital heart disease with right ventricular hypertrophy, the preload of the heart will be influenced by the variation of the intrathoracic pressure. The cardiopulmonary interaction during mechanical ventilation will be an important influence factor on hemodynamics after surgical repair for these patients. As a new mode of mechanical ventilation, NAVA delivers ventilatory assist in proportion to patients' neural effort avoiding over ventilation. The investigators designed a crossover study to evaluate the cardiopulmonary effect in patients with congenital heart disease with right ventricular hypertrophy when ventilated with NAVA postoperatively, compared with the conventional mode of pressure control ventilation and pressure support ventilation. 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. Data are expressed as mean ± standard deviation. Datas from the three registrations will be compared using a repeated-measures ANOVA. The comparison of each mode will be assessed by the SNK methods post hoc test. A p value of less than 0.05 was considered significant.

Tracking Information

NCT #
NCT04825054
Collaborators
Not Provided
Investigators
Study Director: Limin Zhu, M.D. Shanghai Children/s Medical Center, Shanghai Jiaotong University School of Medicine Principal Investigator: Xiaolei Gong, M.D. Shanghai Children/s Medical Center, Shanghai Jiaotong University School of Medicine Study Chair: Zhuoming Xu, Ph. D & M.D. Shanghai Children/s Medical Center, Shanghai Jiaotong University School of Medicine