Clinical trial NCT04825054: Cardiopulmonary Effect of Mechanical Ventilation in Children With Right Ventricular Hypertrophy
Official title: Cardiopulmonary Effect of Mechanical Ventilation in Children Underwent Surgical Repair of Right Ventricular Hypertrophy: Compared With Pressure Control Ventilation, Pressure Support Ventilation and Neurally Adjusted Ventilatory Assist
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart-lung Interaction
Right Ventricular Hypertrophy
Postoperative Care
Congenital Heart Disease
Mechanical Ventilation
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 1. pressure control ventilation
2. pressure support ventilation
3. neurally adjusted ventilatory assist
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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 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.

Eligibility criteria: Inclusion Criteria:

1. Patients underwent surgical repair of right ventricular hypertrophic congenital heart disease
2. Obtain informed consent signed by parents

Exclusion Criteria:

1. Significant residual shunt (more than 2mm), residual obstruction of right ventricular outflow tract (RVOT) or A-V valve insufficiency.
2. Hemodynamic instability (whose inotropic score more than 20);
3. Significant bleed (whose chest drainage more than 5ml/kg/h);
4. Failed to insert the PiCCO catheter
5. Dysfunction and abnormal of esophage;
6. Inclusion in other research protocol

Primary outcomes:
measure: Cardiac output index
timeFrame: Within 72 hours after opeartion
Secondary outcomes:
measure: Peak inspiratory pressure
timeFrame: Within 72 hours after opeartion
measure: Mean airway pressure
timeFrame: Within 72 hours after opeartion
measure: Arterial partial pressure of oxygen
timeFrame: Within 72 hours after opeartion
measure: Arterial partial pressure of carbon dioxide
timeFrame: Within 72 hours after opeartion
measure: Arterial oxygen saturation
timeFrame: Within 72 hours after opeartion
measure: Lactate
timeFrame: Within 72 hours after opeartion
measure: ScvO2
timeFrame: Within 72 hours after opeartion
measure: Urine output
timeFrame: Within 72 hours after opeartion
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Cardiac intensive care unit, Department of cardiothoracic vascular surgery, Shanghai Children's Medical Center, Medical college of Shanghai Jiaotong University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Children's Medical Center, Shanghai Jiaotong Universiry School of Medicine
state: Shanghai
Study officials:
affiliation: Shanghai Children/s Medical Center, Shanghai Jiaotong University School of Medicine
name: Limin Zhu, M.D.
role: STUDY_DIRECTOR
affiliation: Shanghai Children/s Medical Center, Shanghai Jiaotong University School of Medicine
name: Xiaolei Gong, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Children/s Medical Center, Shanghai Jiaotong University School of Medicine
name: Zhuoming Xu, Ph. D & M.D.
role: STUDY_CHAIR
References: