Prone Position During ECMO in Pediatric Patients With Severe ARDS

NCT06369584 | Recruiting

• 1 other identifier: PEPAD
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Pediatric Acute Respiratory Distress Syndrome; Extracorporeal Membrane Oxygenation

Keywords

Extracorporeal Membrane oxygenation; pediatric acute respiratory distress syndrome; prone position ventilation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Failure of supine position

  Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.

• ECMO successful weaning rate

  Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.

• Total duration of ECMO Support

  Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.

• Number of ECMO-free days

  Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.

• Duration of mechanical ventilation days after ECMO successful weaning.

  Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.

Study Arms (2)

prone position during ECMO in pediatric ARDS

EXPERIMENTAL

Procedure: Prone positioning The process of prone positioning requires 5-6 people, with one person acting as the commander responsible for directing and monitoring the implementation of prone positioning. The process of monitoring includes ECMO flow and 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 to protect areas under pressure. During ECMO support period, each patient needs to undergo at least four sessions of prone ventilation. Each session should last between 16 to 24 hours.

Procedure: prone position

supine position during ECMO in pediatric ARDS

NO INTERVENTION

Procedure: Supine position Patients assigned to supine will remain in a semi-recumbent position.

Interventions

prone position PROCEDURE

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.

prone position during ECMO in pediatric ARDS

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Age \< 1 month or \> 18 years old.
• ECMO initiated for more than 48 hours.
• 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).
• Presence of irreversible brain injury or intracranial hypertension.
• Children with irreversible lung disease awaiting lung transplantation.
• Children with abdominal trauma or postoperative acute respiratory distress syndrome (ARDS).
• Children in whom percutaneous cannulation cannot be performed due to unstable hemodynamics within the first 48 hours after ECMO support initiation.
• Other contraindications for performing percutaneous cannulation.
• Liver failure.
• Burn area \>20% body surface area (BSA).

Sponsors & Collaborators

• Seventh Medical Center of PLA General Hospital: lead
• Gansu Provincial Maternal and Child Health Care Hospital: collaborator
• Xian Children's Hospital: collaborator
• People's Hospital of Guangxi Zhuang Autonomous Region: collaborator
• Henan Provincial People's Hospital: collaborator
• Guangdong Provincial People's Hospital: collaborator
• Shenzhen Bao'an Maternal and Child Health Hospital: collaborator
• Zhengzhou Children's Hospital: collaborator

Study Sites (8)

Seventh medical center of Chinese PLA General Hospital

Beijing, Beijing Municipality, 100700, China

RECRUITING

Gansu Provincial Maternal and Child Health Care Hospital

Lanzhou, Gansu, 730050, China

RECRUITING

The Second School of Clinical Medicine, Southern Medical University

Guangzhou, Guangdong, China

RECRUITING

Shenzhen Bao'an Maternity & Child Health Hospital

Shenzhen, Guangdong, 518100, China

RECRUITING

The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, China

RECRUITING

Henan Children's Hospital

Zhengzhou, Henan, 450014, China

RECRUITING

Henan Provincial People's Hospital

Zhengzhou, Henan, 463599, China

RECRUITING

Xi'an Children's Hospital

Xi'an, Shaanxi, 710002, China

RECRUITING

MeSH Terms

Interventions

Prone Position

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Xiaoyang Hong, M.D.

CONTACT

13311057633; jyhongxy@163.com

Zhe Zhao

CONTACT

18500179885; derekpicu@outlook.com

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: April 2, 2024
• First Posted: April 17, 2024
• Study Start: May 9, 2024
• Primary Completion: May 1, 2025
• Study Completion: July 1, 2025
• Last Updated: June 10, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)