Pediatric Acute Respiratory Distress SyndromePEPADNCT06369584
Prone Position During ECMO in Pediatric Patients With Severe ARDS
A study testing prone position in people with Pediatric Acute Respiratory Distress Syndrome and Extracorporeal Membrane Oxygenation, run by Seventh Medical Center of PLA General Hospital at 8 sites in China.
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). Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Pediatric Acute Respiratory Distress Syndrome, Extracorporeal Membrane Oxygenation
- What is being tested?
- prone position
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 8 sitesChina
- Study dates
- 9 May 2024to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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).
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- 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).
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites, 8 recruiting
- Recruiting
Seventh medical center of Chinese PLA General Hospital
Beijing, Beijing Municipality, 100700
Xiaoyang Hong, M.D., 13311057633, jyhongxy@163.com
Zhe Zhao, 18500179885, derekpicu@outlook.com
- Recruiting
The Second School of Clinical Medicine, Southern Medical University
Guangzhou, Guangdong
Yuxiong Guo, M.D., 13423661583, 2003kellylaw@163.com
- Recruiting
Gansu Provincial Maternal and Child Health Care Hospital
Lanzhou, Gansu, 730050
Weikai Wang, M.D., 0931-5188650, 35487284@qq.com
- Recruiting
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi
Hanwu Huang, M.D., 15107710327, 2503133021@qq.com
- Recruiting
Shenzhen Bao'an Maternity & Child Health Hospital
Shenzhen, Guangdong, 518100
Ping Jin, M.D., 18025493395, yanyanab2004@aliyun.com
- Recruiting
Xi'an Children's Hospital
Xi'an, Shaanxi, 710002
Yi Wang, M.D., 18591953652, wangyichengxian@163.com
- Recruiting
Henan Children's Hospital
Zhengzhou, Henan, 450014
Feng Wang, M.D., 0371-85515892, wang.f365@163.com
- Recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan, 463599
Donglaing Cheng, M.D., 18838083052, 41655181@qq.com
About this study
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
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.
- Being tested
- prone position
- Keywords
- Extracorporeal Membrane oxygenation, pediatric acute respiratory distress syndrome, prone position ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prone positionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 7, Day 14, Day 30, Day 60, Day 90
Secondary outcomes (13)
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.
Measured: Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.
ECMO successful weaning rate
ECMO successful weaning rate means the patient still survive for more than 48 hours after weaning from ECMO.
Measured: Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.
Total duration of ECMO Support
Measured: Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.
Number of ECMO-free days
Number of ECMO-free days means the time for the patient to discharge from ECMO successful weaning.
Measured: Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.
Duration of mechanical ventilation days after ECMO successful weaning.
Measured: Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.
Duration of Pediatric Intensive Care Unit (PICU) stay.
Measured: Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.
Duration of hospitalization
Measured: Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.
Incidence of brain injury before discharge
Brain injury was defined as any brain injury from imaging diagnosis or verified by EEG.
Measured: Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.
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.
Measured: Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.
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.
Measured: Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.
Number of ventilator assist pneumonia, bacteriemia, and cannula infection episodes
Measured: Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.
Number of days with hemodynamic support with catecholamines
Measured: Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.
Number of days without hemodynamic support with catecholamines
Measured: Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start9 May 2024
- Primary completion1 May 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seventh Medical Center of PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Gansu Provincial Maternal and Child Health Care Hospital, Xian Children's Hospital, People's Hospital of Guangxi Zhuang Autonomous Region, Henan Provincial People's Hospital, Guangdong Provincial People's Hospital, Shenzhen Bao'an Maternal and Child Health Hospital, Zhengzhou Children's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06369584
- Sponsor's protocol ID
- PEPAD
- Acronym
- PEPAD
- Status last verified
- Jun 2024
- First submitted
- 2 Apr 2024
- Last updated
- 10 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All the data involved in the study should be applied for the investigator after publication.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06369584
- Acronym / sponsor ID
- PEPAD / PEPAD
- Keywords
- Extracorporeal Membrane oxygenation, pediatric acute respiratory distress syndrome, prone position ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- Seventh Medical Center of PLA General HospitalUniversity, hospital or other
- Collaborators
- Gansu Provincial Maternal and Child Health Care Hospital, Xian Children's Hospital, People's Hospital of Guangxi Zhuang Autonomous Region, Henan Provincial People's Hospital, Guangdong Provincial People's Hospital, Shenzhen Bao'an Maternal and Child Health Hospital, Zhengzhou Children's Hospital
- Study start
- 9 May 2024 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prone position during ECMO in pediatric ARDS | Experimental | Procedure: prone positionProcedure: 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. |
| supine position during ECMO in pediatric ARDS | No intervention | –Procedure: Supine position Patients assigned to supine will remain in a semi-recumbent position. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prone positionThe 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. | Procedure or surgery | prone position during ECMO in pediatric ARDS |
Primary outcome
Mortality
Time frame: Day 7, Day 14, Day 30, Day 60, Day 90
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.
13 secondary outcomes
Failure of supine position
Time frame: Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.
ECMO successful weaning rate
Time frame: Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.
Total duration of ECMO Support
Time frame: Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.
Number of ECMO-free days
Time frame: Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.
Duration of mechanical ventilation days after ECMO successful weaning.
Time frame: Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.
Duration of Pediatric Intensive Care Unit (PICU) stay.
Time frame: Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.
Duration of hospitalization
Time frame: Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.
Incidence of brain injury before discharge
Time frame: Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.
Number of days with organ failure
Time frame: Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.
Number of days alive without organ failure
Time frame: Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.
Number of ventilator assist pneumonia, bacteriemia, and cannula infection episodes
Time frame: Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.
Number of days with hemodynamic support with catecholamines
Time frame: Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.
Number of days without hemodynamic support with catecholamines
Time frame: Between inclusion visit (day 1) and day 60, Between inclusion visit and day 90.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
- Individual participant dataSharing planned: No. All the data involved in the study should be applied for the investigator after publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prone position in people with Pediatric Acute Respiratory Distress Syndrome and Extracorporeal Membrane Oxygenation, run by Seventh Medical Center of PLA General Hospital at 8 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaoyang Hong, M.D. (13311057633, jyhongxy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: Day 7, Day 14, Day 30, Day 60, Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2024.