Infant Clinical Trial
Official title:
Short-Term Effect of Prone Positioning in Infants With Severe Acute Respiratory Distress Syndrome
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.
Status | Recruiting |
Enrollment | 14 |
Est. completion date | December 31, 2024 |
Est. primary completion date | August 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 12 Months |
Eligibility | 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. 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 - Other non-inclusion criteria - 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 |
Country | Name | City | State |
---|---|---|---|
Austria | Medical University of Vienna | Vienna |
Lead Sponsor | Collaborator |
---|---|
Medical University of Vienna |
Austria,
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* Note: There are 28 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
Change from baseline oxygenation saturation index at 6 hours | |
Secondary | 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. | Change from baseline LUS score at 6 hours | |
Secondary | 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]. | Change from baseline EELV at 6 hours | |
Secondary | Change in the Distribution of the Tidal Volume | Tidal volume is the average difference of end-inspiratory and end-expiratory impedance measurements [arbitrary units]. | Change from baseline tidal volume at 6 hours |
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