Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04607993 |
Other study ID # |
FNF202043 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
July 1, 2020 |
Est. completion date |
June 30, 2022 |
Study information
Verified date |
February 2022 |
Source |
Children's Hospital of Fudan University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.