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Cardiopulmonary Effect of Mechanical Ventilation in Children With Right Ventricular Hypertrophy

Primary Purpose

Heart-lung Interaction, Right Ventricular Hypertrophy, Postoperative Care

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Mechanical ventilation with NAVA mode
Mechanical ventilation with PCV mode
Mechanical ventilation with PSV mode
Sponsored by
Limin Zhu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart-lung Interaction

Eligibility Criteria

3 Months - 3 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cardiac intensive care unit, Department of cardiothoracic vascular surgery, Shanghai Children's Medical Center, Medical college of Shanghai Jiaotong UniversityRecruiting
  • Shanghai Children's Medical Center, Shanghai Jiaotong Universiry School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

A 60-min trial ventilated with NAVA

A 60-min trial ventilated with PCV

A 60-min trial ventilated with PSV

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Cardiac output index
Cardiac output index messured by PiCCO and echocariography should be improved when ventilated with NAVA or PSV compared with PCV.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
March 1, 2021
Last Updated
March 29, 2021
Sponsor
Limin Zhu
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1. Study Identification

Unique Protocol Identification Number
NCT04825054
Brief Title
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 25, 2021 (Actual)
Primary Completion Date
February 28, 2021 (Actual)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Limin Zhu

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart-lung Interaction, Right Ventricular Hypertrophy, Postoperative Care, Congenital Heart Disease, Mechanical Ventilation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
pressure control ventilation pressure support ventilation neurally adjusted ventilatory assist
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A 60-min trial ventilated with NAVA
Arm Type
Experimental
Arm Description
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.
Arm Title
A 60-min trial ventilated with PCV
Arm Type
Experimental
Arm Description
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.
Arm Title
A 60-min trial ventilated with PSV
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Mechanical ventilation with NAVA mode
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Mechanical ventilation with PCV mode
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Mechanical ventilation with PSV mode
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cardiac output index
Description
Cardiac output index messured by PiCCO and echocariography should be improved when ventilated with NAVA or PSV compared with PCV.
Time Frame
Within 72 hours after opeartion
Secondary Outcome Measure Information:
Title
Peak inspiratory pressure
Description
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.
Time Frame
Within 72 hours after opeartion
Title
Mean airway pressure
Description
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.
Time Frame
Within 72 hours after opeartion
Title
Arterial partial pressure of oxygen
Description
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.
Time Frame
Within 72 hours after opeartion
Title
Arterial partial pressure of carbon dioxide
Description
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.
Time Frame
Within 72 hours after opeartion
Title
Arterial oxygen saturation
Description
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.
Time Frame
Within 72 hours after opeartion
Title
Lactate
Description
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.
Time Frame
Within 72 hours after opeartion
Title
ScvO2
Description
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.
Time Frame
Within 72 hours after opeartion
Title
Urine output
Description
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.
Time Frame
Within 72 hours after opeartion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients underwent surgical repair of right ventricular hypertrophic congenital heart disease Obtain informed consent signed by parents Exclusion Criteria: Significant residual shunt (more than 2mm), residual obstruction of right ventricular outflow tract (RVOT) or A-V valve insufficiency. Hemodynamic instability (whose inotropic score more than 20); Significant bleed (whose chest drainage more than 5ml/kg/h); Failed to insert the PiCCO catheter Dysfunction and abnormal of esophage; Inclusion in other research protocol
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Limin Zhu, M.D.
Phone
+86-21-38626161
Ext
86623
Email
zhulimin121@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaolei Gong, M.D.
Phone
+86-21-38626161
Ext
86623
Email
espresso_1985@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Limin Zhu, M.D.
Organizational Affiliation
Shanghai Children/s Medical Center, Shanghai Jiaotong University School of Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Xiaolei Gong, M.D.
Organizational Affiliation
Shanghai Children/s Medical Center, Shanghai Jiaotong University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zhuoming Xu, Ph. D & M.D.
Organizational Affiliation
Shanghai Children/s Medical Center, Shanghai Jiaotong University School of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Cardiac intensive care unit, Department of cardiothoracic vascular surgery, Shanghai Children's Medical Center, Medical college of Shanghai Jiaotong University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Limin Zhu, MD
Phone
8621-38626161
Ext
86622
Email
zhulimin121@hotmail.com
First Name & Middle Initial & Last Name & Degree
Xiaolei Gong, MD
Phone
8621-38626161
Ext
86623
Email
espresso_1985@126.com
Facility Name
Shanghai Children's Medical Center, Shanghai Jiaotong Universiry School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Limin Zhu, M.D.
Phone
+86-21-38626161
Ext
86623
Email
zhulimin121@hotmail.com
First Name & Middle Initial & Last Name & Degree
Xiaolei Gong, M.D.
Phone
+86-21-38626161
Ext
86623
Email
espresso_1985@126.com
First Name & Middle Initial & Last Name & Degree
Xiaolei Gong, M.D.
First Name & Middle Initial & Last Name & Degree
Limin Zhu, M.D.
First Name & Middle Initial & Last Name & Degree
Chunxiang Li, M.D.
First Name & Middle Initial & Last Name & Degree
Yujie Liu, M.D.
First Name & Middle Initial & Last Name & Degree
Haibo Zhang, M.D.&Ph.D.
First Name & Middle Initial & Last Name & Degree
Jinghao Zheng, M.D.&Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No

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Cardiopulmonary Effect of Mechanical Ventilation in Children With Right Ventricular Hypertrophy

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