Cardiopulmonary Effect of Mechanical Ventilation in Children With Right Ventricular Hypertrophy

NCT04825054 | Unknown DMC

• 1 other identifier: SCMC-CHC2021006
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Heart-lung Interaction; Right Ventricular Hypertrophy; Postoperative Care; Congenital Heart Disease; Mechanical Ventilation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Peak inspiratory pressure

  Within 72 hours after opeartion

• Mean airway pressure

  Within 72 hours after opeartion

• Arterial partial pressure of oxygen

  Within 72 hours after opeartion

• Arterial partial pressure of carbon dioxide

  Within 72 hours after opeartion

• Arterial oxygen saturation

  Within 72 hours after opeartion

Study Arms (3)

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.

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.

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.

Device: Mechanical ventilation with PSV mode

Interventions

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.

A 60-min trial ventilated with NAVA

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.

A 60-min trial ventilated with PCV

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.

A 60-min trial ventilated with PSV

Eligibility Criteria

• Age: 3 Months - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients underwent surgical repair of right ventricular hypertrophic congenital heart disease
• Obtain informed consent signed by parents

You may not qualify if:

• 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;

Sponsors & Collaborators

• Limin Zhu: lead

Study Sites (2)

Cardiac intensive care unit, Department of cardiothoracic vascular surgery, Shanghai Children's Medical Center, Medical college of Shanghai Jiaotong University

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

Shanghai Children's Medical Center, Shanghai Jiaotong Universiry School of Medicine

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 39076742 DERIVED

MeSH Terms

Conditions

Hypertrophy, Right Ventricular; Heart Defects, Congenital

Interventions

Respiration, Artificial

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Hypertrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Resuscitation; Emergency Treatment; Respiratory Therapy

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Zhuoming Xu, Ph. D & M.D.

  Shanghai Children/s Medical Center, Shanghai Jiaotong University School of Medicine

  STUDY CHAIR

Central Study Contacts

Limin Zhu, M.D.

CONTACT

+86-21-38626161; zhulimin121@hotmail.com

Xiaolei Gong, M.D.

CONTACT

+86-21-38626161; espresso_1985@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy chief physician

Model Details: 1. pressure control ventilation 2. pressure support ventilation 3. neurally adjusted ventilatory assist

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: April 1, 2021
• Study Start: February 25, 2021
• Primary Completion: February 28, 2021
• Study Completion: December 31, 2021
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)