Prone Position During ECMO in Pediatric Patients With Severe ARDS

Extracorporeal Membrane Oxygenation Clinical Trial

— PEPAD  

Official title:

Efficiency and Safety of Prone Position During Extracorporeal Membrane Oxygenation in Pediatric Patients With Severe Acute Respiratory Distress Syndrome: A Multi-center Randomized Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06369584
• Other study ID #: PEPAD
• Status: Recruiting
• Phase: N/A
• Start date: May 9, 2024
• Est. completion date: July 1, 2025

Study information

• Verified date: June 2024
• Source: Seventh Medical Center of PLA General Hospital
• Contact: Xiaoyang Hong, M.D.
• Phone: 13311057633
• Email: jyhongxy[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In 2023, the second Pediatric Acute Lung Injury Consensus Conference (PALICC-2) updated the diagnostic and management guidelines for Pediatric Acute Respiratory Distress Syndrome (PARDS). The guidelines do not provide sufficient evidence-based recommendations on whether prone positioning ventilation is necessary for severe PARDS patients. However, the effectiveness of Extracorporeal Membrane Oxygenation (ECMO) in treating severe PARDS has been fluctuating around 70% according to recent data from Extracorporeal Life Support Organization (ELSO).

In 2018, the Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE) study group conducted a retrospective analysis and concluded that ECMO does not significantly improve survival rates for severe PARDS. However, this retrospective study mainly focused on data from North America, with significant variations in annual ECMO support cases among different centers, which may introduce bias. With advancements in ECMO technology and materials, ECMO has become safer and easier to operate. In recent years, pediatric ECMO support technology has rapidly grown in mainland China and is increasingly being widely used domestically to rescue more children promptly.

ECMO can also serve as a salvage measure for severely ARDS children who have failed conventional mechanical ventilation treatment. When optimizing ventilator parameters (titrating positive end expiratory pressure (PEEP) levels, neuromuscular blockers, prone positioning), strict fluid management alone cannot maintain satisfactory oxygenation (P/F<80mmHg or Oxygen Index (OI) >40 for over 4 hours or OI >20 for over 24 hours), initiating ECMO can achieve lung-protective ventilation strategies with ultra-low tidal volumes to minimize ventilator-associated lung injury.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 7
• Est. completion date: July 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

Inclusion Criteria:

• Severe PARDS and meets the criteria for ECMO support, has received ECMO support for less than 48 hours.

• Informed consent obtained from the child's direct/legal guardian

Exclusion Criteria:

1. Age < 1 month or > 18 years old.

2. ECMO initiated for more than 48 hours.

3. Children who have undergone cardiopulmonary resuscitation (CPR) for more than 10 minutes before ECMO initiation without restoration of spontaneous circulation, or children undergoing extracorporeal cardiopulmonary resuscitation (ECPR).

4. Presence of irreversible brain injury or intracranial hypertension.

5. Children with irreversible lung disease awaiting lung transplantation.

6. Children with abdominal trauma or postoperative acute respiratory distress syndrome (ARDS).

7. Children in whom percutaneous cannulation cannot be performed due to unstable hemodynamics within the first 48 hours after ECMO support initiation.

8. Other contraindications for performing percutaneous cannulation.

9. Liver failure.

10. Burn area >20% body surface area (BSA).

Related Conditions & MeSH terms

• Acute Lung Injury
• Extracorporeal Membrane Oxygenation
• Pediatric Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Procedure:
• prone position
The process of prone positioning requires 5-6 people, with one person acting as the commander responsible for directing and monitoring. The process of monitoring includes ECMO flow and the vital signs. The second person is in charge of the patient's head, including endotracheal intubation, ventilator lines, and jugular ECMO cannula. The third person is responsible for femoral ECMO cannula and central venous line. The fourth to sixth individuals are responsible for rotating the patient's torso towards the side without an ECMO tube. Before initiating prone ventilation, pressure ulcer protection patches should be placed on the patient's forehead, ears, anterior chest, and iliac crest to protect areas under pressure. During ECMO support period, each patient needs to undergo at least four sessions of prone ventilation until their condition improves enough to discontinue ECMO support. Each session should last between 16 to 24 hours.

Locations

Country	Name	City	State
China	Seventh medical center of Chinese PLA General Hospital	Beijing	Beijing
China	The Second School of Clinical Medicine, Southern Medical University	Guangzhou	Guangdong
China	Gansu Provincial Maternal and Child Health Care Hospital	Lanzhou	Gansu
China	The People's Hospital of Guangxi Zhuang Autonomous Region	Nanning	Guangxi
China	Shenzhen Bao'an Maternity & Child Health Hospital	Shenzhen	Guangdong
China	Xi'an Children's Hospital	Xi'an	Shaanxi
China	Henan Children's Hospital	Zhengzhou	Henan
China	Henan Provincial People's Hospital	Zhengzhou	Henan

Sponsors (8)

Lead Sponsor	Collaborator
Seventh Medical Center of PLA General Hospital	Gansu Provincial Maternal and Child Health Care Hospital, Guangdong Provincial People's Hospital, Henan Provincial People's Hospital, People's Hospital of Guangxi, Shenzhen Bao'an Maternal and Child Health Hospital, Xian Children's Hospital, Zhengzhou Children's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Survive means that the patient would survive without ECMO support and survival requires follow-up until at least 30 days after ECMO withdrawal. Whether the child requires long-term mechanical ventilation or home oxygen therapy after ECMO withdrawal will be considered.; A protocolized management regarding weaning of ECMO will be applied to both groups in all involved centers.; The planned analysis will model the risk of death.	Day 7, Day 14, Day 30, Day 60, Day 90
Secondary	Failure of supine position	The definition of failure of supine position: For patient ventilated with ECMO on supine position, when the fraction of oxygen of ECMO was set at 100% and fraction of ventilator oxygen was over 70%, saturation of the patient could not reach above 80%. This condition was defined as failure of supine position.	Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.
Secondary	ECMO successful weaning rate	ECMO successful weaning rate means the patient still survive for more than 48 hours after weaning from ECMO.	Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.
Secondary	Total duration of ECMO Support		Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.
Secondary	Number of ECMO-free days	Number of ECMO-free days means the time for the patient to discharge from ECMO successful weaning.	Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.
Secondary	Duration of mechanical ventilation days after ECMO successful weaning.		Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.
Secondary	Duration of Pediatric Intensive Care Unit (PICU) stay.		Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.
Secondary	Duration of hospitalization		Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.
Secondary	Incidence of brain injury before discharge	Brain injury was defined as any brain injury from imaging diagnosis or verified by EEG.	Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.
Secondary	Number of days with organ failure	Defined by Phoenix Sepsis Score. The Phoenix Sepsis Score ranged from 0-13, and the higher score indicates a worse prognosis.	Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.
Secondary	Number of days alive without organ failure	Defined by Phoenix Sepsis Score. The Phoenix Sepsis Score ranged from 0-13, and the higher score indicates a worse prognosis.	Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.
Secondary	Number of ventilator assist pneumonia, bacteriemia, and cannula infection episodes		Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.
Secondary	Number of days with hemodynamic support with catecholamines		Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.
Secondary	Number of days without hemodynamic support with catecholamines		Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.