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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A 60-min trial ventilated with NAVA | Experimental | Patients underwent surgical repair of right ventricular hypertrophic congenital heart disease. Each patient will undergo three 60-min trials with 30-min wash out 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. |
|
| A 60-min trial ventilated with PCV | Experimental | Patients underwent surgical repair of right ventricular hypertrophic congenital heart disease. Each patient will undergo three 60-min trials with 30-min wash out 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. |
|
| A 60-min trial ventilated with PSV | Experimental | Patients underwent surgical repair of right ventricular hypertrophic congenital heart disease. Each patient will undergo three 60-min trials with 30-min wash out 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mechanical ventilation with NAVA mode | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac output index | Cardiac output index messured by PiCCO and echocariography should be improved when ventilated with NAVA or PSV compared with PCV. | Within 72 hours after opeartion |
| Measure | Description | Time Frame |
|---|---|---|
| Peak inspiratory pressure | Peak inspiratory pressure (PIP) should be recorded at the last 3 minutes ventilated with NAVA, PCV or PSV. The average of PIP and MAP of every breath within 3 min will be regarded as the airway pressure of every trial. 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Limin Zhu, M.D. | Contact | +86-21-38626161 | 86623 | zhulimin121@hotmail.com |
| Xiaolei Gong, M.D. | Contact | +86-21-38626161 | 86623 | espresso_1985@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Limin Zhu, M.D. | Shanghai Children/s Medical Center, Shanghai Jiaotong University School of Medicine | Study Director |
| Xiaolei Gong, M.D. | Shanghai Children/s Medical Center, Shanghai Jiaotong University School of Medicine |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiac intensive care unit, Department of cardiothoracic vascular surgery, Shanghai Children's Medical Center, Medical college of Shanghai Jiaotong University | Recruiting | Shanghai | Shanghai Municipality | 200127 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39076742 | Derived | Gong X, Zhu L, Zhang M, Liu Y, Li C, Xu Z, Zheng J. Utilizing Spontaneous Ventilation Modes in Patients Underwent Corrective Surgery for Right Ventricular Outflow Tract Obstructive Congenital Heart Disease: A Crossover Study. Rev Cardiovasc Med. 2023 May 11;24(5):143. doi: 10.31083/j.rcm2405143. eCollection 2023 May. |
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|
| Mechanical ventilation with PCV mode | Device | 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. |
|
| Mechanical ventilation with PSV mode | Device | 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. |
|
| Within 72 hours after opeartion |
| Mean airway pressure | Mean Airway pressure (MAP) should be recorded at the last 3 minutes ventilated with NAVA, PCV or PSV. The average of PIP and MAP of every breath within 3 min will be regarded as the airway pressure of every trial. 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. | Within 72 hours after opeartion |
| Arterial partial pressure of oxygen | The arterial blood gas will be sampled at the last 5 min of every trial. Arterial partial pressure of oxygen (PaO2) of the blood gas analysis during different ventilatory mode of NAVA, PCV or PSV will be compared. 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. | Within 72 hours after opeartion |
| Arterial partial pressure of carbon dioxide | The arterial blood gas will be sampled at the last 5 min of every trial. Arterial partial pressure of carbon dioxide (PaCO2) of the blood gas analysis during different ventilatory mode of NAVA, PCV or PSV will be compared. 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. | Within 72 hours after opeartion |
| Arterial oxygen saturation | The arterial blood gas will be sampled at the last 5 min of every trial. Arterial oxygen saturation (SaO2) of the blood gas analysis during different ventilatory mode of NAVA, PCV or PSV will be compared. 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. | Within 72 hours after opeartion |
| Lactate | The datas of organ purfusion such as lactate during different ventilatory mode of NAVA, PCV or PSV will be gathered from the blood sample at the last 5 min of every trial. 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. | Within 72 hours after opeartion |
| ScvO2 | The datas of organ purfusion such as ScvO2 during different ventilatory mode of NAVA, PCV or PSV will be gathered from the blood sample at the last 5 min of every trial. 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. | Within 72 hours after opeartion |
| Urine output | The total urine output during different ventilatory mode of NAVA, PCV or PSV will be recorded. 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. | Within 72 hours after opeartion |
| Zhuoming Xu, Ph. D & M.D. | Shanghai Children/s Medical Center, Shanghai Jiaotong University School of Medicine | Study Chair |
|
| Shanghai Children's Medical Center, Shanghai Jiaotong Universiry School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200127 | China |
|
| ID | Term |
|---|---|
| D017380 | Hypertrophy, Right Ventricular |
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D006332 | Cardiomegaly |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006984 | Hypertrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018376 | Cardiovascular Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| ID | Term |
|---|---|
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012151 | Resuscitation |
| D004638 | Emergency Treatment |
| D012138 | Respiratory Therapy |
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