Heart-lung InteractionNCT04825054
Cardiopulmonary Effect of Mechanical Ventilation in Children With Right Ventricular Hypertrophy
A study testing Mechanical ventilation with NAVA mode, Mechanical ventilation with PCV mode and Mechanical ventilation with PSV mode in people with Heart-lung Interaction and Right Ventricular Hypertrophy, run by Limin Zhu at 2 sites in China.
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… Read more about this study
- Who is it for?
- Ages 3 months to 3 years
- Conditions the study is for
- Heart-lung Interaction, Right Ventricular Hypertrophy, Postoperative Care
- What is being tested?
- Mechanical ventilation with NAVA mode, Mechanical ventilation with PCV mode and Mechanical ventilation with PSV mode
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesChina
- Study dates
- 25 Feb 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients underwent surgical repair of right ventricular hypertrophic congenital heart disease
- Obtain informed consent signed by parents
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Cardiac intensive care unit, Department of cardiothoracic vascular surgery, Shanghai Children's Medical Center, Medical college of Shanghai Jiaotong University
Shanghai, Shanghai Municipality, 200127
Limin Zhu, MD, 8621-38626161 ext. 86622, zhulimin121@hotmail.com
Xiaolei Gong, MD, 8621-38626161 ext. 86623, espresso_1985@126.com
- Recruiting
Shanghai Children's Medical Center, Shanghai Jiaotong Universiry School of Medicine
Shanghai, Shanghai Municipality, 200127
Limin Zhu, M.D., +86-21-38626161 ext. 86623, zhulimin121@hotmail.com
Xiaolei Gong, M.D., +86-21-38626161 ext. 86623, espresso_1985@126.com
About this study
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
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.
Read the 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.
- Conditions
- Heart-lung Interaction, Right Ventricular Hypertrophy, Postoperative Care, Congenital Heart Disease, Mechanical Ventilation
- Being tested
- Mechanical ventilation with NAVA mode, Mechanical ventilation with PCV mode, Mechanical ventilation with PSV mode
- Medical subject headings
- Hypertrophy, Right Ventricular, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical ventilation with NAVA modeDevice
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 modeDevice
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 modeDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Mechanical ventilation with NAVA mode |
| 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. Receives: Device: Mechanical ventilation with PCV mode |
| 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. Receives: Device: Mechanical ventilation with PSV mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac output index
Cardiac output index messured by PiCCO and echocariography should be improved when ventilated with NAVA or PSV compared with PCV.
Measured: Within 72 hours after opeartion
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within 72 hours after opeartion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start25 Feb 2021
- Primary completion28 Feb 2021
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart-lung InteractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 1. pressure control ventilation 2. pressure support ventilation 3. neurally adjusted ventilatory assist
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Limin Zhu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Limin Zhu, Shanghai Jiao Tong University School of Medicine
- Investigators
- Limin Zhu, M.D., Study director, Shanghai Children/s Medical Center, Shanghai Jiaotong University School of MedicineXiaolei Gong, M.D., Principal investigator, Shanghai Children/s Medical Center, Shanghai Jiaotong University School of MedicineZhuoming Xu, Ph. D & M.D., Study chair, Shanghai Children/s Medical Center, Shanghai Jiaotong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04825054
- Sponsor's protocol ID
- SCMC-CHC2021006
- Status last verified
- Mar 2021
- First submitted
- 1 Mar 2021
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39076742
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04825054
- Acronym / sponsor ID
- SCMC-CHC2021006
- Conditions
- Heart-lung Interaction, Right Ventricular Hypertrophy, Postoperative Care, Congenital Heart Disease, Mechanical Ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Limin ZhuUniversity, hospital or other
- Study start
- 25 Feb 2021 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- 1. pressure control ventilation 2. pressure support ventilation 3. neurally adjusted ventilatory assist
| Arm | Type | Receives |
|---|---|---|
| A 60-min trial ventilated with NAVA | Experimental | Device: Mechanical ventilation with NAVA modePatients 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 | Device: Mechanical ventilation with PCV modePatients 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 | Device: Mechanical ventilation with PSV modePatients 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. |
Who may qualify
- Ages
- 3 months to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patients underwent surgical repair of right ventricular hypertrophic congenital heart disease
- Obtain informed consent signed by parents
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mechanical ventilation with NAVA modeTo 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. | Device | A 60-min trial ventilated with NAVA |
| Mechanical ventilation with PCV modeTo 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. | Device | A 60-min trial ventilated with PCV |
| Mechanical ventilation with PSV modeTo 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. | Device | A 60-min trial ventilated with PSV |
Primary outcome
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.
8 secondary outcomes
Peak inspiratory pressure
Time frame: Within 72 hours after opeartion
Mean airway pressure
Time frame: Within 72 hours after opeartion
Arterial partial pressure of oxygen
Time frame: Within 72 hours after opeartion
Arterial partial pressure of carbon dioxide
Time frame: Within 72 hours after opeartion
Arterial oxygen saturation
Time frame: Within 72 hours after opeartion
Lactate
Time frame: Within 72 hours after opeartion
ScvO2
Time frame: Within 72 hours after opeartion
Urine output
Time frame: Within 72 hours after opeartion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Derived from this study: PubMed 39076742Gong 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Limin Zhu, M.D. study director
Shanghai Children/s Medical Center, Shanghai Jiaotong University School of Medicine
Xiaolei Gong, M.D. principal investigator
Shanghai Children/s Medical Center, Shanghai Jiaotong University School of Medicine
Zhuoming Xu, Ph. D & M.D. study chair
Shanghai Children/s Medical Center, Shanghai Jiaotong University School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical ventilation with NAVA mode, Mechanical ventilation with PCV mode and Mechanical ventilation with PSV mode in people with Heart-lung Interaction and Right Ventricular Hypertrophy, run by Limin Zhu at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Limin Zhu, M.D. (+86-21-38626161 ext. 86623, zhulimin121@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac output index (time frame: Within 72 hours after opeartion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04825054, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.