Cardiopulmonary Effect of Mechanical Ventilation in Children With Right

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04825054
Study type	Interventional
Source	Shanghai Jiao Tong University School of Medicine
Contact	Limin Zhu, M.D.
Phone	+86-21-38626161
Email	zhulimin121@hotmail.com
Status	Recruiting
Phase	N/A
Start date	February 25, 2021
Completion date	December 31, 2021

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05654272` - Development of CIRC Technologies
Recruiting	`NCT04992793` - Paediatric Brain Injury Following Cardiac Interventions
Recruiting	`NCT05213598` - Fontan Associated Liver Disease and the Evaluation of Biomarkers for Disease Severity Assessment
Completed	`NCT04136379` - Comparison of Home and Standard Clinic Monitoring of INR in Patients With CHD
Completed	`NCT04814888` - 3D Airway Model for Pediatric Patients
Recruiting	`NCT04920643` - High-exchange ULTrafiltration to Enhance Recovery After Pediatric Cardiac Surgery	N/A
Completed	`NCT05934578` - Lymphatic Function in Patients With Fontan Circulation: Effect of Physical Training	N/A
Recruiting	`NCT06041685` - Effect of Local Warming for Arterial Catheterization in Pediatric Anesthesia	N/A
Recruiting	`NCT05902013` - Video Laryngoscopy Versus Direct Laryngoscopy for Nasotracheal Intubation	N/A
Not yet recruiting	`NCT05687292` - Application of a Clinical Decision Support System to Reduce Mechanical Ventilation Duration After Cardiac Surgery
Not yet recruiting	`NCT05524324` - Cardiac Resynchronization Therapy in Adult Congenital Heart Disease With Systemic Right Ventricle: RIGHT-CRT	N/A
Completed	`NCT02746029` - Cardiac Murmurs in Children: Predictive Value of Cardiac Markers
Completed	`NCT02537392` - Multi-micronutrient Supplementation During Peri-conception and Congenital Heart Disease	N/A
Completed	`NCT03119090` - Fontan Imaging Biomarkers (FIB) Study
Recruiting	`NCT02258724` - Swiss National Registry of Grown up Congenital Heart Disease Patients
Terminated	`NCT02046135` - Sodium Bicarbonate to Prevent Acute Kidney Injury in Children Undergoing Cardiac Surgery	Phase 2
Completed	`NCT01966237` - Milrinone Pharmacokinetics and Acute Kidney Injury
Recruiting	`NCT01184404` - Bosentan Improves Clinical Outcome of Adults With Congenital Heart Disease or Mitral Valve Lesions Who Undergo CArdiac Surgery	N/A
Completed	`NCT01548950` - Drug Therapy and Surgery in Congenital Heart Disease With Pulmonary Hypertension	N/A
Completed	`NCT01821287` - Nutritional Failure in Infants With Single Ventricle Congenital Heart Disease	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Cardiopulmonary Effect of Mechanical Ventilation in Children With Right Ventricular Hypertrophy

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms