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

Primary Purpose

Investigative Techniques

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Prone position ventilation technique
Sponsored by
Children's Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Investigative Techniques

Eligibility Criteria

undefined - 1 Year (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CICU, Cardiovascular Center, Childrens Hospital of Fudan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Prone position ventilation technique

Control group

Arm Description

Prone position ventilation for children with congenital heart disease after surgery

conventional postoperative position, no prone position ventilation

Outcomes

Primary Outcome Measures

Oxygenation index
Oxygenation index refers to a goal in respiratory therapy,OI(mmHg)=PaO2/FiO2 It is a continuous variable.

Secondary Outcome Measures

Lung compliance
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.

Full Information

First Posted
October 28, 2020
Last Updated
December 2, 2022
Sponsor
Children's Hospital of Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT04607993
Brief Title
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Investigative Techniques

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prone position ventilation technique
Arm Type
Experimental
Arm Description
Prone position ventilation for children with congenital heart disease after surgery
Arm Title
Control group
Arm Type
No Intervention
Arm Description
conventional postoperative position, no prone position ventilation
Intervention Type
Behavioral
Intervention Name(s)
Prone position ventilation technique
Intervention Description
Inform the children's family members of the purpose and method of prone position ventilation Assess the fixation of various catheters Suspend feeding before placing prone position Confirm the time to start prone position ventilation under the joint assessment of medical staff Place the child in a prone position with the participation of researchers, doctors and nursing staff, with the child's head tilted to one side to avoid damage to the eyes and nose due to compression, and the arms are bent upward to form a "W" . Bend both lower limbs downward to form an "M" shape, and use a soft pillow cushion to measure the knee joints to avoid compression The whole process ensures the smooth fixation of tracheal intubation and various catheters Proper sedation during prone position ventilation to achieve good human-machine synchronization At least 6-8 hours in prone position every day
Primary Outcome Measure Information:
Title
Oxygenation index
Description
Oxygenation index refers to a goal in respiratory therapy,OI(mmHg)=PaO2/FiO2 It is a continuous variable.
Time Frame
at 6th hours after enrollment
Secondary Outcome Measure Information:
Title
Lung compliance
Description
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.
Time Frame
at 6th hours after enrollment

10. Eligibility

Sex
All
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
xu yulu
Organizational Affiliation
Children's Hospital of Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
CICU, Cardiovascular Center, Childrens Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201102
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34922610
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.
Results Reference
derived

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

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