Infants With Severe Acute Respiratory Distress Syndrome: The Prone Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 12
SponsorMedical University of Vienna
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Prone positioning
Other interventionTurn patient in prone position after surfactant administration.
Treatment groups
14 Participants
are divided into 2 treatment groupsGroup A: Prone GroupExperimental treatment 1 intervention
Group B: Supine GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in Oxygenation saturation index
Oxygenation saturation index (OSI) defined by \[FiO2 x mean airway pressure x 100\]/Peripheral oxygen saturation (SpO2) in millibar \[mbar\] (wean FiO2 to maintain SpO2 ≤ 97% to calculate OSI). OSI values will be calculated after a stable value of SpO2 and mean airway pressure (MAP) will be reached (see ventilation management). The OSI gradient will be calculated as follows: 100\*((OSI (0) - OSI (6h)) / OSI (0) = change of OSI in %. OSI (0) accounts for the OSI prior to the prone position (intervention) and OSI (6h) accounts for the OSI six hours after the intervention.
Time frame
Change from baseline oxygenation saturation index at 6 hoursSecondary outcomes
1
Chang in Lung Ultrasound
Each lung (left and right) is divided into 6 areas (upper anterior, lower anterior, upper lateral, lower lateral, upper posterior, lower posterior). The Lung Ultrasound Score is assigned as follows: 0 indicates A-pattern (defined by the presence of the only A-lines); 1, B-pattern (defined as the presence of ≥3 well-spaced B-lines); 2, severe B pattern (defined as the presence of crowded and coalescent B-lines with or without consolidations limited to the subpleural space); and 3, extended consolidations. The total LUS score ranges from 0 (best) to 36.
Time frame
Change from baseline LUS score at 6 hours2
Change in the Distribution of the End-Expiratory Lung Volume
End-expiratory lung impedance (EELV) is the average of the measured impedance at the end of expiration \[arbitrary units\].
Time frame
Change from baseline EELV at 6 hours3
Change in the Distribution of the Tidal Volume
Tidal volume is the average difference of end-inspiratory and end-expiratory impedance measurements \[arbitrary units\].
Time frame
Change from baseline tidal volume at 6 hoursSponsors and contacts
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Source ClinicalTrials.gov