Clinical trial NCT04607993: Study on the Effectiveness and Feasibility of Prone Position Ventilation Technology in Congenital Heart Disease
Official title: Study on the Effectiveness and Feasibility of Prone Position Ventilation Technique for Postoperative Acute Lung Injury in Infants With Congenital Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Investigative Techniques
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2020-10-29
Enrollment: 68
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Oxygenation index
timeFrame: at 6th hours after enrollment
Secondary outcomes:
measure: Lung compliance
timeFrame: at 6th hours after enrollment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: CICU, Cardiovascular Center, Childrens Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Children's Hospital of Fudan University
name: xu yulu
role: PRINCIPAL_INVESTIGATOR
References:
citation: Xu YL, Mi YP, Zhu MX, Ren YH, Gong WJ, Fu WJ, Wang HM, Ye L, Wang Y, Zhou XY, Chen Y, Chen YY, Gu LQ, Gu Y, Jia B, Hu J, Hu XJ. Feasibility and effectiveness of prone position ventilation technique for postoperative acute lung injury in infants with congenital heart disease: study protocol for a prospective randomized study. Trials. 2021 Dec 18;22(1):929. doi: 10.1186/s13063-021-05895-1.