Pediatric Acute Respiratory Distress Syndrome Asia Study

NCT04068038 | Completed

• 1 other identifier: 2017/3076(2)
• Study Type: observational
• Target: 738
• Locations: 10 countries
• Sites: 19

Brief Summary

Mortality rates in children with pediatric acute respiratory distress syndrome (PARDS) are higher in Asia compared to other regions. In adults with acute respiratory distress syndrome, the only therapy that improves mortality rates is a lung protective ventilation strategy. The pediatric ventilation recommendations are extrapolated from evidence in adults, including ventilation with low tidal volume, low peak/plateau pressures and high-end expiratory pressure. A recent retrospective study of ventilation practices in Asia showed varying practices with regards to pulmonary and non-pulmonary therapies, including ventilation. This study aims to determine the prevalence and outcomes of PARDS in the Pediatric Acute and Critical Care Medicine Asian Network (PACCMAN). This study will also determine the use of pulmonary (mechanical ventilation, steroids, neuromuscular blockade, surfactant, pulmonary vasodilators, prone positioning) and non-pulmonary (nutrition, sedation, fluid management, transfusion) PARDS therapies. To achieve this aim, a prospective observational study which involves systematic screening of all pediatric intensive care unit (PICU) admissions and collection of pertinent clinical data will be conducted. Recruitment will be consecutive and follow up will continue to intensive care discharge.

Conditions

Acute Respiratory Distress Syndrome; Pediatric Intensive Care Unit; Mechanical Ventilation

Outcome Measures

Primary Outcomes (2)

• Prevalence of PARDS

  Number of participants diagnosed with PARDS over number of intensive care admissions

  Through study completion

• Mortality

  Number of PARDS participants who died over number of participants diagnosed with PARDS

  up to 60 days

Secondary Outcomes (3)

• Ventilator free days

  up to 28 days

• Intensive Care Unit free days

  up to 28 days

• Extracorporeal membrane oxygenation

  up to 28 days

Other Outcomes (2)

• Composite mortality and ECMO

  up to 60 days

• Sensitivity analysis

  up to 60 days

Interventions

Ventilation protocol OTHER

An evidence based ventilation protocol will be implemented at participating sites. This will include limits on peak inspiratory pressure (28cmH2O), driving pressure (16cmH2O), tidal volume (mild 8ml/kg, mod/severe 6ml/kg), positive end expiratory pressure to fraction of inspired oxygen table, permissive hypercarbia (mild allow pH 7.30, mod/severe allow pH 7.20) and permissive hypoxia (mild SpO2 92-97%, mod/severe SpO2 88-92%).

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All PICU admission will be screened daily and those who meet the PALICC criteria for PARDS will be recruited and consented (if necessary). We will include those on non-invasive ventilation and alternative modes of ventilation. However, a minimum positive end expiratory pressure of 5cmH2O is necessary for inclusion, as per PALICC. Patients with any type of cardiorespiratory comorbidity will also be included if they fulfill the PALICC criteria for special populations (cyanotic heart disease, chronic lung disease and left ventricular failure). Patients who have limitation of care (i.e. do-not-resuscitate orders) or develop brainstem death will also be included to enable calculation of prevalence.

You may qualify if:

• Satisfies the Pediatric Acute Lung Injury Consensus Conference (PALICC) criteria for PARDS

You may not qualify if:

• Premature neonates with a corrected age of less than 33 weeks and perinatal lung disease
• High flow nasal cannula

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead
• Children's Hospital of Chongqing Medical University: collaborator
• Guangzhou Women and Children's Medical Center: collaborator
• Shengjing Hospital: collaborator
• Children's Hospital of Fudan University: collaborator
• Hong Kong Children's Hospital: collaborator
• Sarawak General Hospital: collaborator
• Universiti Kebangsaan Malaysia Medical Centre: collaborator
• University of Malaya: collaborator
• King Chulalongkorn Memorial Hospital: collaborator
• Siriraj Hospital: collaborator
• Ramathibodi Hospital: collaborator
• National Children's Hospital, Vietnam: collaborator
• Post Graduate Institute of Medical Education and Research, Chandigarh: collaborator
• Rumah Sakit Anak dan Bunda Harapan Kita: collaborator
• Sanglah General Hospital: collaborator
• General Hospital of North Sumatera University: collaborator
• Hyogo Prefectural Kobe Children's Hospital: collaborator
• Aga Khan University: collaborator
• National University Hospital, Singapore: collaborator
• Singapore Clinical Research Institute: collaborator

Study Sites (19)

Guangzhou Women and Children's Medical Center

Guangzhou, Guangzhou, China

Location

Shengjing hospital of China Medical University

Shenyang, Liaoning, China

Location

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Location

Chongqing Hospital

Chongqing, Sichuan, China

Location

Hong Kong Children's Hospital

Kowloon Bay, Kowloon, Hong Kong

Location

Post Graduate Institute of Medical Education and Research

Chandigarh, India

Location

Sanglah Hospital Denpasar

Denpasar, Bali, Indonesia

Location

Harapan Kita Children and Women hospital

Jakarta, Indonesia

Location

Hyogo Prefectural Kobe Children's Hospital

Hyōgo, Kobe, Japan

Location

Universiti Kebangsaan Malaysia Medical Centre

Bandar Tun Razak, Kuala Lumpur, Malaysia

Location

Sarawak General Hospital

Kuching, Sarawak, Malaysia

Location

University Malaya Medical Centre

Kuala Lumpur, Malaysia

Location

Aga Khan University Hospital

Karachi, Pakistan

Location

KK Women's and Children's Hospital

Singapore, 229899, Singapore

Location

National University Hospital, Singapore

Singapore, Singapore

Location

Siriraj Hospital

Bangkok Noi, Bangkok, Thailand

Location

King Chulalongkorn Memorial Hospital

Bangkok, Thailand

Location

Ramathibodi hospital

Bangkok, Thailand

Location

National Hospital of Pediatrics

Đống Đa, Hanoi, Vietnam

Location

Related Publications (1)

• Wong JJM, Dang H, Gan CS, Phan PH, Kurosawa H, Aoki K, Lee SW, Ong JSM, Fan LJ, Tai CW, Chuah SL, Lee PC, Chor YK, Ngu L, Anantasit N, Liu C, Xu W, Wati DK, Gede SIB, Jayashree M, Liauw F, Pon KM, Huang L, Chong JY, Zhu X, Hon KLE, Leung KKY, Samransamruajkit R, Cheung YB, Lee JH; Pediatric Acute & Critical Care Medicine Asian Network (PACCMAN). Lung-Protective Ventilation for Pediatric Acute Respiratory Distress Syndrome: A Nonrandomized Controlled Trial. Crit Care Med. 2024 Oct 1;52(10):1602-1611. doi: 10.1097/CCM.0000000000006357. Epub 2024 Jun 26.

  PMID: 38920618 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Respiratory fluid Blood

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Judith Ju Ming Wong

  KK Women's and Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 60 Days
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Pediatric Critical Care

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: August 28, 2019
• Study Start: August 1, 2019
• Primary Completion: March 31, 2023
• Study Completion: July 7, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

ID (2); CN (4); MY (3); IN (1); PA (1); VN (1); SG (2); HK (1); JP (1); TH (3)