Acute Respiratory Distress Syndrome Clinical Trial
— PULSAROfficial title:
Physiological Effects of Prone vs. sUpine Position on Lung Recruitability in infantS/Children With Acute Respiratory Distress Syndrome
NCT number | NCT06020404 |
Other study ID # | 5922 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | September 1, 2023 |
Est. completion date | September 2025 |
Verified date | August 2023 |
Source | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In adult patients with acute respiratory distress syndrome (ARDS), the beneficial effects of prone position (PP) have been well investigated and explored; it reduces intrapulmonary shunt (Qs/Qt) and enhances lung recruitment, modifying both lung ventilation (VA) and lung perfusion (Q) distribution, finally generating an improvement in VA/Q matching and reversing oxygenation impairment;it reduces right ventricular afterload, increase cardiac index in subjects with preload reserve and reverse acute cor pulmonale in severe ARDS patients, but in infants and children there is still a lack of clear evidence. Taken together, these effects explain why PP improves oxygenation, limits the occurrence of ventilator-induced lung injury and improves survival. Prone position is simple to perform in infants and in some neonatal and pediatric intensive care units is already commonly accomplished. However, a detailed analysis of the respective effects of high PEEP and prone position is lacking in infants/children with ARDS, while these two tools may interfere and/or act coherently. A recent multicenter, retrospective analysis of patients with pediatric acute respiratory distress syndrome (PARDS) describes how patients managed with lower PEEP relative to FIO2 than recommended by the ARDSNet model had higher mortality, suggesting that future clinical trials targeting PEEP management in PARDS are needed. We designed a physiological study to investigate the physiological effects of prone positioning on lung recruitability in infants/children with acute respiratory distress syndrome.
Status | Recruiting |
Enrollment | 15 |
Est. completion date | September 2025 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 18 Years |
Eligibility | Inclusion Criteria: - PaO2/FiO2 < 200 in the supine position, with a standard PEEP of 5 cmH2O; - PaCO2 <45mmHg; - Absence of history of chronic respiratory disease or heart failure or congenital heart disease (Modified Ross heart failure classification for children < II); - Not underweight infants/children defined as a low body mass index (BMI) for age; - Absence of any contraindication to PP (Appendix 1); - Written informed consent of both parents and the legal guardian. Exclusion Criteria: - Barotrauma; - Less than 4 weeks of age (new-born physiology); - Exacerbation of asthma; - Chest trauma; - Pulmonary oedema/haemorrhage; - Severe Neutropenia (<500 WBC/mm3); - Haemodynamic instability (Systolic blood pressure < 5th percentile or mean arterial pressure < 5th percentile adjusted by age); - Lactic acidosis (lactate >5 mmol/L) and/or clinically diagnosed shock; - Metabolic Acidosis (pH <7.30 with normal- or hypo-carbia); - Chronic kidney failure requiring dialysis before PICU admission; - Upper gastrointestinal bleeding. - Refusal to sign written informed consent of both parents and the legal guardian. |
Country | Name | City | State |
---|---|---|---|
Italy | Giorgio Conti | Rome |
Lead Sponsor | Collaborator |
---|---|
Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Italy,
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Costa EL, Borges JB, Melo A, Suarez-Sipmann F, Toufen C Jr, Bohm SH, Amato MB. Bedside estimation of recruitable alveolar collapse and hyperdistension by electrical impedance tomography. Intensive Care Med. 2009 Jun;35(6):1132-7. doi: 10.1007/s00134-009-1 — View Citation
Curley MA, Hibberd PL, Fineman LD, Wypij D, Shih MC, Thompson JE, Grant MJ, Barr FE, Cvijanovich NZ, Sorce L, Luckett PM, Matthay MA, Arnold JH. Effect of prone positioning on clinical outcomes in children with acute lung injury: a randomized controlled t — View Citation
Fineman LD, LaBrecque MA, Shih MC, Curley MA. Prone positioning can be safely performed in critically ill infants and children. Pediatr Crit Care Med. 2006 Sep;7(5):413-22. doi: 10.1097/01.PCC.0000235263.86365.B3. — View Citation
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Khemani RG, Parvathaneni K, Yehya N, Bhalla AK, Thomas NJ, Newth CJL. Positive End-Expiratory Pressure Lower Than the ARDS Network Protocol Is Associated with Higher Pediatric Acute Respiratory Distress Syndrome Mortality. Am J Respir Crit Care Med. 2018 — View Citation
Lupton-Smith A, Argent A, Rimensberger P, Frerichs I, Morrow B. Prone Positioning Improves Ventilation Homogeneity in Children With Acute Respiratory Distress Syndrome. Pediatr Crit Care Med. 2017 May;18(5):e229-e234. doi: 10.1097/PCC.0000000000001145. — View Citation
Menga LS, Delle Cese L, Rosa T, Cesarano M, Scarascia R, Michi T, Biasucci DG, Ruggiero E, Dell'Anna AM, Cutuli SL, Tanzarella ES, Pintaudi G, De Pascale G, Sandroni C, Maggiore SM, Grieco DL, Antonelli M. Respective Effects of Helmet Pressure Support, Co — View Citation
Pelosi P, Tubiolo D, Mascheroni D, Vicardi P, Crotti S, Valenza F, Gattinoni L. Effects of the prone position on respiratory mechanics and gas exchange during acute lung injury. Am J Respir Crit Care Med. 1998 Feb;157(2):387-93. doi: 10.1164/ajrccm.157.2. — View Citation
Riera J, Perez P, Cortes J, Roca O, Masclans JR, Rello J. Effect of high-flow nasal cannula and body position on end-expiratory lung volume: a cohort study using electrical impedance tomography. Respir Care. 2013 Apr;58(4):589-96. doi: 10.4187/respcare.02 — View Citation
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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | effect of prone positioning on lung recruitability | PaO2/FiO2 ratio | at the end of the supine and prone position | |
Secondary | difference in gas exchanges | PaO2/FiO2, PaCO2, PaO2 | at the end of the supine and prone position | |
Secondary | ventilatory ratio | minute ventilation (ml/min) × PaCO2 (mmHg)]/(predicted body weight × 100 × 37.5) | at the end of the supine and prone position | |
Secondary | global impedance-derived End-expiratory lung volume | effects of prone position on End-expiratory lung volume, measured with electrical impedance tomography | at the end of the supine and prone position | |
Secondary | regional impedance-derived End-expiratory lung volume | effects of prone position on End-expiratory lung impedance in the four regions of the lungs (ventral, mid-ventral, mid-dorsal, dorsal), measured with electrical impedance tomography | at the end of the supine and prone position | |
Secondary | tidal volume distribution | effect of prone position on % tidal volume distribution in the four regions of the lung (ventral, mid-ventral, mid-dorsal, dorsal), explored with electrical impedance tomography | at the end of the supine and prone position | |
Secondary | global impedance-derived lung dynamic strain | change in impedance due to tidal volume / end expiratory lung impedance, both measured with electrical impedance tomography | at the end of the supine and prone position | |
Secondary | regional impedance-derived lung dynamic strain | change in impedance due to tidal volume / end expiratory lung impedance in the four regions of the lungs (ventral, mid-ventral, mid-dorsal, dorsal), measured with electrical impedance tomography | at the end of the supine and prone position | |
Secondary | number of displacements of the endotracheal tube during prone position | safety endpoint | 2 hours | |
Secondary | number of oxygen desaturations during prone position | safety endpoint | 2 hours |
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