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

NCT04607993 | Completed

• 1 other identifier: FNF202043
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Investigative Techniques

Outcome Measures

Primary Outcomes (1)

• Oxygenation index

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

  at 6th hours after enrollment

Secondary Outcomes (1)

• Lung compliance

  at 6th hours after enrollment

Study Arms (2)

Prone position ventilation technique

EXPERIMENTAL

Prone position ventilation for children with congenital heart disease after surgery

Behavioral: Prone position ventilation technique

Control group

NO INTERVENTION

conventional postoperative position, no prone position ventilation

Interventions

Prone position ventilation technique BEHAVIORAL

1. Inform the children's family members of the purpose and method of prone position ventilation 2. Assess the fixation of various catheters 3. Suspend feeding before placing prone position 4. Confirm the time to start prone position ventilation under the joint assessment of medical staff 5. 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 6. The whole process ensures the smooth fixation of tracheal intubation and various catheters 7. Proper sedation during prone position ventilation to achieve good human-machine synchronization 8. At least 6-8 hours in prone position every day

Prone position ventilation technique

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

CICU, Cardiovascular Center, Childrens Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

Related Publications (1)

• 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.

  PMID: 34922610 DERIVED

Study Officials

• xu yulu

  Children's Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2020
• First Posted: October 29, 2020
• Study Start: July 1, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: December 5, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)