Cardiopulmonary Effect of Mechanical Ventilation in Children With Right Ventricular Hypertrophy
NCT ID: NCT04825054
Last Updated: 2021-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2021-02-25
2021-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
2. pressure support ventilation
3. neurally adjusted ventilatory assist
SUPPORTIVE_CARE
SINGLE
Study Groups
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A 60-min trial ventilated with NAVA
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.
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.
A 60-min trial ventilated with PCV
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.
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.
A 60-min trial ventilated with PSV
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.
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
2. Obtain informed consent signed by parents
Exclusion Criteria
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
3 Months
3 Years
ALL
No
Sponsors
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Limin Zhu
OTHER
Responsible Party
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Limin Zhu
Deputy chief physician
Principal Investigators
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Limin Zhu, M.D.
Role: STUDY_DIRECTOR
Shanghai Children/s Medical Center, Shanghai Jiaotong University School of Medicine
Xiaolei Gong, M.D.
Role: PRINCIPAL_INVESTIGATOR
Shanghai Children/s Medical Center, Shanghai Jiaotong University School of Medicine
Zhuoming Xu, Ph. D & M.D.
Role: STUDY_CHAIR
Shanghai Children/s Medical Center, Shanghai Jiaotong University School of Medicine
Locations
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Cardiac intensive care unit, Department of cardiothoracic vascular surgery, Shanghai Children's Medical Center, Medical college of Shanghai Jiaotong University
Shanghai, Shanghai Municipality, China
Shanghai Children's Medical Center, Shanghai Jiaotong Universiry School of Medicine
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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SCMC-CHC2021006
Identifier Type: -
Identifier Source: org_study_id
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