Prone Position in infantS/Children With Acute Respiratory Distress Syndrome

NCT06020404 | Unknown

• 1 other identifier: 5922
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prone Position; Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• effect of prone positioning on lung recruitability

  PaO2/FiO2 ratio

  at the end of the supine and prone position

Secondary Outcomes (9)

• difference in gas exchanges

  at the end of the supine and prone position

• ventilatory ratio

  at the end of the supine and prone position

• global impedance-derived End-expiratory lung volume

  at the end of the supine and prone position

• regional impedance-derived End-expiratory lung volume

  at the end of the supine and prone position

• tidal volume distribution

  at the end of the supine and prone position

Study Arms (2)

Controls

EXPERIMENTAL

Eligible patients will undergo the experimental protocol.

Procedure: supine position; Procedure: prone position

Patients

EXPERIMENTAL

Eligible patients will undergo the experimental protocol.

Procedure: supine position; Procedure: prone position

Interventions

supine position PROCEDURE

At the end of the PEEP trial (i.e. at PEEP 5 cmH2O), patients will lay in the supine position for 15 minutes arterial blood gases will be performed and then a one-breath derecruitment maneuver (5-second exhalation, respiratory rate \< 8 bpm) from PEEP 5 cmH2O to 0 cmH2O will be conducted to assess baseline functional residual capacity (FRC), defined as the EELI measured at 0 PEEP.

Controls; Patients

prone position PROCEDURE

After the supine step, each enrolled patient will be placed in the prone position for 1 hour. For safety reasons, enteral feeding will be interrupted 30 minutes before prone positioning and re-established after the study ending. During pronation FiO2 will be increased up to 80% and then gradually decreased to the baseline value within the first 30 minutes of prone positioning. After 30 minutes of PEEP 12 cmH2O (provided that plateau and driving pressures did not exceed 30 cmH2O and 15 cmH2O, respectively) to stabilize lung volumes, the same measurements applied for the supine step will be performed. Any further modifications in the MV settings will be discouraged over the entire course of the study; nonetheless, if needed to achieve the SpO2 target, an increase in FiO2 will be allowed and recorded. In case of sudden worsening of the oxygenation impairment or haemodynamic, 100% FiO2 will be set, and the patient will be promptly positioned in the supine semi-recumbent position.

Controls; Patients

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Giorgio Conti

Rome, 00168, Italy

RECRUITING

Related Publications (15)

• Guerin C, Reignier J, Richard JC, Beuret P, Gacouin A, Boulain T, Mercier E, Badet M, Mercat A, Baudin O, Clavel M, Chatellier D, Jaber S, Rosselli S, Mancebo J, Sirodot M, Hilbert G, Bengler C, Richecoeur J, Gainnier M, Bayle F, Bourdin G, Leray V, Girard R, Baboi L, Ayzac L; PROSEVA Study Group. Prone positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013 Jun 6;368(23):2159-68. doi: 10.1056/NEJMoa1214103. Epub 2013 May 20.

  PMID: 23688302 RESULT

• 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.157.2.97-04023.

  PMID: 9476848 RESULT

• Gattinoni L, Taccone P, Carlesso E, Marini JJ. Prone position in acute respiratory distress syndrome. Rationale, indications, and limits. Am J Respir Crit Care Med. 2013 Dec 1;188(11):1286-93. doi: 10.1164/rccm.201308-1532CI.

  PMID: 24134414 RESULT

• 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 trial. JAMA. 2005 Jul 13;294(2):229-37. doi: 10.1001/jama.294.2.229.

  PMID: 16014597 RESULT

• 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.

  PMID: 28328787 RESULT

• Bhandari AP, Nnate DA, Vasanthan L, Konstantinidis M, Thompson J. Positioning for acute respiratory distress in hospitalised infants and children. Cochrane Database Syst Rev. 2022 Jun 6;6(6):CD003645. doi: 10.1002/14651858.CD003645.pub4.

  PMID: 35661343 RESULT

• 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.

  PMID: 16885792 RESULT

• 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 Jul 1;198(1):77-89. doi: 10.1164/rccm.201707-1404OC.

  PMID: 29373802 RESULT

• Sinha P, Calfee CS, Beitler JR, Soni N, Ho K, Matthay MA, Kallet RH. Physiologic Analysis and Clinical Performance of the Ventilatory Ratio in Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2019 Feb 1;199(3):333-341. doi: 10.1164/rccm.201804-0692OC.

  PMID: 30211618 RESULT

• 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, Continuous Positive Airway Pressure, and Nasal High-Flow in Hypoxemic Respiratory Failure: A Randomized Crossover Clinical Trial. Am J Respir Crit Care Med. 2023 May 15;207(10):1310-1323. doi: 10.1164/rccm.202204-0629OC.

  PMID: 36378814 RESULT

• 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.02086.

  PMID: 23050520 RESULT

• Chen L, Del Sorbo L, Grieco DL, Junhasavasdikul D, Rittayamai N, Soliman I, Sklar MC, Rauseo M, Ferguson ND, Fan E, Richard JM, Brochard L. Potential for Lung Recruitment Estimated by the Recruitment-to-Inflation Ratio in Acute Respiratory Distress Syndrome. A Clinical Trial. Am J Respir Crit Care Med. 2020 Jan 15;201(2):178-187. doi: 10.1164/rccm.201902-0334OC.

  PMID: 31577153 RESULT

• Bachmann MC, Morais C, Bugedo G, Bruhn A, Morales A, Borges JB, Costa E, Retamal J. Electrical impedance tomography in acute respiratory distress syndrome. Crit Care. 2018 Oct 25;22(1):263. doi: 10.1186/s13054-018-2195-6.

  PMID: 30360753 RESULT

• 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/s00134-009-1447-y. Epub 2009 Mar 3.

  PMID: 19255741 RESULT

• Baudin F, Emeriaud G, Essouri S, Beck J, Portefaix A, Javouhey E, Guerin C. Physiological Effect of Prone Position in Children with Severe Bronchiolitis: A Randomized Cross-Over Study (BRONCHIO-DV). J Pediatr. 2019 Feb;205:112-119.e4. doi: 10.1016/j.jpeds.2018.09.066. Epub 2018 Nov 14.

  PMID: 30448014 RESULT

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Supine Position; Prone Position

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2x2 cross-over design

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: August 31, 2023
• Study Start: September 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2025
• Last Updated: February 23, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)