Cardiopulmonary Effect of Mechanical Ventilation in Children With Right Ventricular Hypertrophy

March 29, 2021 updated by: Limin Zhu

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Recruiting
        • Cardiac intensive care unit, Department of cardiothoracic vascular surgery, Shanghai Children's Medical Center, Medical college of Shanghai Jiaotong University
        • Contact:
        • Contact:
      • Shanghai, Shanghai, China, 200127
        • Recruiting
        • Shanghai Children's Medical Center, Shanghai Jiaotong Universiry School of Medicine
        • Contact:
        • Contact:
        • Principal Investigator:
          • Xiaolei Gong, M.D.
        • Principal Investigator:
          • Limin Zhu, M.D.
        • Sub-Investigator:
          • Chunxiang Li, M.D.
        • Sub-Investigator:
          • Yujie Liu, M.D.
        • Sub-Investigator:
          • Haibo Zhang, M.D.&Ph.D.
        • Sub-Investigator:
          • Jinghao Zheng, M.D.&Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: 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.
Experimental: 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.
Device: 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.
Experimental: 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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac output index
Time Frame: Within 72 hours after opeartion
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak inspiratory pressure
Time Frame: Within 72 hours after opeartion
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.
Within 72 hours after opeartion
Mean airway pressure
Time Frame: Within 72 hours after opeartion
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
Time Frame: Within 72 hours after opeartion
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
Time Frame: Within 72 hours after opeartion
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
Time Frame: Within 72 hours after opeartion
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
Time Frame: Within 72 hours after opeartion
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
Time Frame: Within 72 hours after opeartion
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
Time Frame: Within 72 hours after opeartion
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Limin Zhu

Investigators

  • Study Director: Limin Zhu, M.D., Shanghai Children/s Medical Center, Shanghai Jiaotong University School of Medicine
  • Principal Investigator: Xiaolei Gong, M.D., Shanghai Children/s Medical Center, Shanghai Jiaotong University School of Medicine
  • Study Chair: Zhuoming Xu, Ph. D & M.D., Shanghai Children/s Medical Center, Shanghai Jiaotong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2021

Primary Completion (Actual)

February 28, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

March 1, 2021

First Submitted That Met QC Criteria

March 29, 2021

First Posted (Actual)

April 1, 2021

Study Record Updates

Last Update Posted (Actual)

April 1, 2021

Last Update Submitted That Met QC Criteria

March 29, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCMC-CHC2021006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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