Infants with Severe Acute Respiratory Distress Syndrome: the Prone Trial

NCT ID: NCT05002478

Last Updated: 2024-11-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-30
• Study Completion Date: 2026-12-31

Brief Summary

The main objective is to determine the short-term effect of prone positioning in infants with infection-associated severe acute respiratory distress syndrome. The investigators compare oxygenation parameters and measurements from electrical impedance tomography (EIT) and lung ultrasonography (LUS) in mechanically ventilated infants in prone position versus supine position after surfactant administration.

Detailed Description

The acute respiratory distress syndrome (ARDS) is an acute lung injury that can be triggered by pulmonary (direct lung injury) and extrapulmonary (indirect lung injury) etiologies. Pediatric ARDS (pARDS) occurs in approximately 3% of children admitted to intensive care units (ICUs) and is associated with approximately 17% mortality. The primary etiologies of pARDS have been summarized as pneumonia (35%), aspiration (15%), sepsis (13%), near-drowning (9%), cardiac disease (7%), and other clinical conditions (21%). ARDS manifests as pulmonary inflammation, alveolar edema, and hypoxemic respiratory failure. Mechanical ventilation remains an essential component in the care of patients with ARDS. Many adjunctive treatments rely on pathophysiological considerations. The pathophysiology of ARDS is characterized by inflammatory, proliferative, and fibrotic phases. The different phases induce a ventilation-perfusion mismatch. Inflammation causes surfactant inactivation and depletion. A number of clinical studies have reported clinical benefits following the instillation of exogenous surfactant in pediatric patients with acute respiratory failure. On the other side, prone positioning seem to be a promising intervention in critically ill infants and children with infection-associated acute lung injury. However, data conflict on the use of prone positioning in pediatric patients with acute lung injury.

Turning patients with moderate to severe lung disease into prone position has shown many positive effects. Prolonged intervals of prone positioning have been associated with a decrease in mortality in adult patients with acute respiratory failure. An increase in partial pressure of oxygen (PaO2)/fraction of inspired oxygen (FiO2) has been described after 4 hours in prone position in adult patients with severe acute respiratory failure. Similarly, a decrease of the oxygenation index has been found after 8 hours of prone positioning in adult patients with respiratory failure from coronavirus disease of 2019 (COVID-19) associated acute respiratory distress syndrome. The process of prone positioning appeared safe also in critically ill infants and children. In a randomized control trial, it has been shown that in 90% of prone positioning oxygenation index decreased of more than 10% in children with acute lung injury.

Electrical impedance tomography (EIT) and lung ultrasound (LUS) are two non-invasive methods to monitor aeration and lung function parameters. EIT can quantify regional distribution of ventilation as well as improvement in end-expiratory air content. EIT has been used at bedside in critically ill adult patients to measure effects of prone position and also in infants with respiratory distress syndrome. On the other side, LUS has become an increasingly popular diagnostic bedside tool for lung examination. It is considered reliable and fast to detect various lung-related pathologies, such as pneumonia, atelectasis, pneumothorax, and interstitial syndrome.

The main objective is to determine the short-term effect of prone positioning in infants with infection-associated severe acute respiratory distress syndrome. To accomplish this, oxygenation parameters and measurements from EIT and LUS will be compared in mechanically ventilated infants in prone position versus supine position after surfactant administration.

Conditions

Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS); Surfactant Dysfunction; Infant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Prone Group

Turn patient in prone position after surfactant administration. After 6 hours turn patient in supine position and perform EIT and LUS.

Group Type: EXPERIMENTAL

Prone positioning

Intervention Type: OTHER

Turn patient in prone position after surfactant administration.

Supine Group

Leave patient in supine position after surfactant administration. After 6 hours perform EIT and LUS.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Prone positioning

Turn patient in prone position after surfactant administration.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients hospitalized at Pediatric Intensive Care Unit (PICU) or Neonatal Intensive Care Unit (NICU) of the Medical University Vienna.
• Patients aged >36 weeks (corrected gestational age) and <24 months.
• Patient intubated and mechanically ventilated for at least 6 hours, with an expected requirement of invasive ventilatory support for at least 12 hours.
• Clinical picture strongly suggestive for acute bronchiolitis or pneumonia (fever, fine crackles, prolonged expiration, lung hyperinflation and/or findings of new infiltrates consistent with acute pulmonary parenchymal disease on chest X-ray).
• Severe pediatric acute respiratory distress syndrome (ARDS), defined by OSI ≥12.3 (wean FIO2 to maintain SpO2 ≤ 97% to calculate oxygen saturation index).
• Written informed consent obtained from parents.

• Indication not to attempt resuscitation
• Patient already recruited for other clinical studies
• Patients who already received surfactant in the last 4 weeks
• Thoracic skin lesions or wounds on the thorax, where the EIT-electrode-belt would be placed

Exclusion Criteria

• Clinical context

• Need for O2 supplementation to maintain SpO2>94% in the 4 weeks preceding hospitalization in the PICU/NICU
• Cyanotic congenital heart disease Cardiogenic pulmonary edema
• Severe pulmonary hypertension
• Untreated pneumothorax
• Severe neurological abnormalities
• Other severe congenital anomalies such as congenital diaphragmatic hernia
• Ongoing cardiopulmonary resuscitation or limitation of life support
• Contradictions for prone positioning (adapted from Guerin, C., et al., Prone positioning in severe acute respiratory distress syndrome. N Engl J Med, 2013. 368(23): p. 2159-68):

• Intracranial pressure >30 millimeters of mercury (mmHg) in supine position or cerebral perfusion pressure <60 mmHg
• Massive hemoptysis requiring an immediate surgical or interventional radiology procedure
• Tracheal surgery or sternotomy during the previous 15 days
• Serious facial trauma or facial surgery during the previous 15 days
• Deep venous thrombosis treated for less than 2 days
• Cardiac pacemaker inserted in the last 2 days
• Unstable spine, femur, or pelvic fractures
• Use of extracorporeal membrane oxygenation (ECMO) before inclusion
• Lung transplantation
• Burns on more than 20% of the body surface

• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Tobias Werther

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tobias Werther

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

Medical University of Vienna

Vienna, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Tobias Werther

Role: CONTACT

tobias.werther@meduniwien.ac.at

+4314040032320

Michael Hermon

Role: CONTACT

michael.hermon@meduniwien.ac.at

+4314040032320

Facility Contacts

Tobias Werther

Role: primary

tobias.werther@meduniwien.ac.at

014040032320

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Other Identifiers

1426/2021

Identifier Type: -

Identifier Source: org_study_id