Study on the Effectiveness and Feasibility of Prone Position Ventilation Technology in Congenital Heart Disease

Not Applicable

Completed

• Conditions: Investigative Techniques
• Interventions: Behavioral: Prone position ventilation technique

• Registration Number: NCT04607993
• Lead Sponsor: Children's Hospital of Fudan University

Brief Summary

The purpose of this study was to compare the effects of conventional lying position and prone position ventilation on infants with acute lung injury after surgery for congenital heart disease. To explore the effectiveness and feasibility of prone position ventilation for children with acute lung injury after congenital heart disease surgery.

Detailed Description

The prone position has been used to treat severe hypoxemia in patients with acute respiration dysfunction syndrome (ARDS) since the 1970s, and it has significant effectiveness in improving gas exchange. Acute lung injury (ALI) is a common complication after congenital heart disease. The clinical manifestation is refractory hypoxemia. At present, mechanical ventilation is one of the main methods for the treatment of acute lung injury-induced respiratory distress syndrome. Prone position ventilation refers to placing the patient in the prone position during mechanical ventilation to expand the lungs in the atelectasis area and improve the ratio of lung ventilation and perfusion.

Prone position ventilation technology as an important lung protection ventilation strategy has been widely used clinically at home and abroad. Compared with adults, children are more convenient and easy to implement. Due to the exact mechanism of improving oxygenation function, the current domestic and foreign development of pediatric prone ventilation technology is mainly focused on children with ARDS. There are few studies on high-quality application effects after pediatric cardiac surgery, and almost no research has been carried out, especially for pediatric heart The indications for the implementation of the prone position after the disease surgery, the specific standardized process including the position angle, the prone duration plan, etc. all need to be studied. Therefore, there is an urgent need to develop prone position ventilation technology for critically ill children with congenital heart disease after surgery to reduce postoperative pulmonary complications and shorten the time of mechanical ventilation.

Study Timeline

• Study Start: 2020-07-01
• Study First Submitted: 2020-10-28
• Study First Submitted QC: 2020-10-28
• Study First Posted: 2020-10-29
• Status Verified: 2022-02
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Last Update Submitted: 2022-12-02
• Last Update Posted: 2022-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• Patients with lung injury after congenital heart disease or chest X-ray CT suggest that pulmonary complications need to strengthen body drainage
• Establish artificial airway, such as tracheal intubation
• Children aged 0-12 months
• Stable hemodynamics, more than 72 hours after surgery
• Informed consent of family members

Exclusion Criteria

• Unstable hemodynamics, severe hypotension, ventricular arrhythmia
• Intracranial hypertension
• Active acute bleeding
• Spinal injuries and untreated unstable fractures, orthopedic surgery or recent abdominal surgery
• Facial trauma
• Severe pneumothorax
• Delayed chest closure and wound infection, children who need to be immobilized

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prone position ventilation technique	Prone position ventilation technique	Prone position ventilation for children with congenital heart disease after surgery

Primary Outcome Measures

Name	Time	Method
Oxygenation index	at 6th hours after enrollment	Oxygenation index refers to a goal in respiratory therapy,OI(mmHg)=PaO2/FiO2 It is a continuous variable.

Secondary Outcome Measures

Name	Time	Method
Lung compliance	at 6th hours after enrollment	Lung compliance refers to the change in lung volume caused by a change in unit pressure, which represents the impact of changes in chest pressure on lung volume. It would be obtained by ventilator . It is a continuous variable. Its unit is ml/cmH2O.

Trial Locations

Locations (1)

CICU, Cardiovascular Center, Childrens Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China