Artificial Increase in Chest Wall Elastance as an Alternative to Prone Positioning in Moderate-to-severe ARDS.

NCT03719937 | Suspended

• 1 other identifier: 1505
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

During moderate to severe ARDS, sessions of prone positioning lead to lung and chest wall mechanics changes that modify regional ventilation, with a final redistribution of tidal volume and PEEP towards dependent lung regions: this limits ventilator-induced lung injury, increases oxygenation and convincingly improves clinical outcome. Physiological data indicate that the increase in chest wall elastance is crucial in determining the benefit by prone positioning on oxygenation. In some patients, however, prone positioning may not be feasible or safe due to particular comorbidities and/or technical issues. In the present pilot-feasibility study enrolling 15 subjects with moderate to severe ARDS in whom prone positioning is contraindicated or unfeasible, we aim at assessing whether and to what extent an artificial increase in chest wall elastance while the patient is in the supine position may yield a significant benefit to oxygenation. The increase in chest wall elastance will be achieved placing 100g/kg weight on the anterior chest wall of the patient while he/she is in the supine position: this approach previoulsy appeared safe and effective in case reports and small case series. Patient's position will be standardized (30 degrees head-up, semi seated position). This one-arm sequential study will evaluate the effects of the procedure on gas exchange, haemodynamics, lung and chest wall mechanics, alveolar recruitment (measured with the nitrogen washout-technique and multiple PV curves) and tidal volume and PEEP distribution (assessed with electrical impedance tomography).

Conditions

Acute Respiratory Distress Syndrome

Keywords

prone positioning; chest wall mechanics; alveolar recruitment; acute respiratory distress syndrome

Outcome Measures

Primary Outcomes (1)

• oxygenation

  PaO2/FiO2 ratio

  120 minutes after the intervention

Secondary Outcomes (7)

• Alveolar recruitment

  1 and 2 hours after the intervention

• tidal volume dsitribution

  1 and 2 hours after the intervention

• Lung stress

  1 and 2 hours after the intervention

• Dynamic strain

  1 and 2 hours after the intervention

• Driving pressure

  1 and 2 hours after the intervention

Study Arms (1)

anterior chest wall weight

EXPERIMENTAL

moderate to severe ARDS patients in whom prone positioning is contraindicated. Patients will have a 100 g/kg weight placed on the anterior chest wall, while in the supine/semirecumbant position. The weights will be placed on the patients' chest for 120 minutes, and then removed. A number of measurements will be recorded before and after the procedure.

Device: weight on the anterior chest of the patient

Interventions

weight on the anterior chest of the patient DEVICE

The investigators aim at assessing whether and to what extent an artificial increase in chest wall elastance, while the patient is in the supine position, may yield a significant benefit to oxygenation. The increase in chest wall elastance will be will be achieved placing a 100 g/kg weight on the anterior chest wall of the patient while he/she is in the supine/semirecumbant position. The weights will be placed on the patients' chest for 120 minutes, and then removed. A number of measurements will be recorded before and after the procedure.

anterior chest wall weight

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with ARDS and moderate to severe oxygenation impairment (PaO2/FiO2≤150 mmHg while receiving controlled mechanical ventilation with PEEP=5 cmH2O) will be the studied population.
• Acute respiratory failure within 1 week of a known clinical insult or new or worsening respiratory symptoms;
• Bilateral infiltrates at the chest x-ray or CT scan, not fully explained by effusions, lobar/lung collapse, or nodules;
• Respiratory failure not fully explained by cardiac failure or fluid overload; objective assessment required to exclude hydrostatic edema if no risk factor present.
• PaO2/FiO2 ratio\<150 mmHg after 30 mins - 1 hour of mechanical ventilation with PEEP=5 cmH2O(14).
• Written informed consent.
• Prone positioning deemed non-feasible by the attending clinician, or presence of at least one of the following absolute contraindications for prone positioning(5)
• Serious facial trauma or facial surgery during the previous 15 days
• Deep venous thrombosis treated for less than 2 days
• Unstable spine, femur, or pelvic fractures
• Pregnant women
• Intracranial pressure \>30 mm Hg or cerebral perfusion pressure \<60 mm

You may not qualify if:

• Chest trauma
• Cardiothoracic surgery in the last 4/6 weeks
• Cardiac PM inserted the last 2 days
• Haemodynamic instability (MAP \< 65 mmHg despite vasoactive/inotrope support)
• Chest tube with air leaks
• Presence of intrinsic PEEP \> 1 cmH2O
• BMI \< 18
• Height \< 150 cm
• More than 48 hours from endotracheal intubation to the time of randomization

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

General ICU, A. Gemelli hospital

Rome, 00100, Italy

Location

Related Publications (18)

• Laffey JG, Bellani G, Pham T, Fan E, Madotto F, Bajwa EK, Brochard L, Clarkson K, Esteban A, Gattinoni L, van Haren F, Heunks LM, Kurahashi K, Laake JH, Larsson A, McAuley DF, McNamee L, Nin N, Qiu H, Ranieri M, Rubenfeld GD, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators and the ESICM Trials Group. Potentially modifiable factors contributing to outcome from acute respiratory distress syndrome: the LUNG SAFE study. Intensive Care Med. 2016 Dec;42(12):1865-1876. doi: 10.1007/s00134-016-4571-5. Epub 2016 Oct 18.

  PMID: 27757516 RESULT

• Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.

  PMID: 10793162 RESULT

• Briel M, Meade M, Mercat A, Brower RG, Talmor D, Walter SD, Slutsky AS, Pullenayegum E, Zhou Q, Cook D, Brochard L, Richard JC, Lamontagne F, Bhatnagar N, Stewart TE, Guyatt G. Higher vs lower positive end-expiratory pressure in patients with acute lung injury and acute respiratory distress syndrome: systematic review and meta-analysis. JAMA. 2010 Mar 3;303(9):865-73. doi: 10.1001/jama.2010.218.

  PMID: 20197533 RESULT

• Papazian L, Forel JM, Gacouin A, Penot-Ragon C, Perrin G, Loundou A, Jaber S, Arnal JM, Perez D, Seghboyan JM, Constantin JM, Courant P, Lefrant JY, Guerin C, Prat G, Morange S, Roch A; ACURASYS Study Investigators. Neuromuscular blockers in early acute respiratory distress syndrome. N Engl J Med. 2010 Sep 16;363(12):1107-16. doi: 10.1056/NEJMoa1005372.

  PMID: 20843245 RESULT

• 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, Pelosi P, Vitale G, Pesenti A, D'Andrea L, Mascheroni D. Body position changes redistribute lung computed-tomographic density in patients with acute respiratory failure. Anesthesiology. 1991 Jan;74(1):15-23. doi: 10.1097/00000542-199101000-00004.

  PMID: 1986640 RESULT

• Samanta S, Samanta S, Soni KD. Supine chest compression: alternative to prone ventilation in acute respiratory distress syndrome. Am J Emerg Med. 2014 May;32(5):489.e5-6. doi: 10.1016/j.ajem.2013.11.014. Epub 2013 Nov 13.

  PMID: 24332252 RESULT

• Mentzelopoulos SD, Roussos C, Zakynthinos SG. Prone position reduces lung stress and strain in severe acute respiratory distress syndrome. Eur Respir J. 2005 Mar;25(3):534-44. doi: 10.1183/09031936.05.00105804.

  PMID: 15738300 RESULT

• Dellamonica J, Lerolle N, Sargentini C, Beduneau G, Di Marco F, Mercat A, Richard JC, Diehl JL, Mancebo J, Rouby JJ, Lu Q, Bernardin G, Brochard L. PEEP-induced changes in lung volume in acute respiratory distress syndrome. Two methods to estimate alveolar recruitment. Intensive Care Med. 2011 Oct;37(10):1595-604. doi: 10.1007/s00134-011-2333-y. Epub 2011 Aug 25.

  PMID: 21866369 RESULT

• Ranieri VM, Giuliani R, Fiore T, Dambrosio M, Milic-Emili J. Volume-pressure curve of the respiratory system predicts effects of PEEP in ARDS: "occlusion" versus "constant flow" technique. Am J Respir Crit Care Med. 1994 Jan;149(1):19-27. doi: 10.1164/ajrccm.149.1.8111581.

  PMID: 8111581 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

• Mauri T, Yoshida T, Bellani G, Goligher EC, Carteaux G, Rittayamai N, Mojoli F, Chiumello D, Piquilloud L, Grasso S, Jubran A, Laghi F, Magder S, Pesenti A, Loring S, Gattinoni L, Talmor D, Blanch L, Amato M, Chen L, Brochard L, Mancebo J; PLeUral pressure working Group (PLUG-Acute Respiratory Failure section of the European Society of Intensive Care Medicine). Esophageal and transpulmonary pressure in the clinical setting: meaning, usefulness and perspectives. Intensive Care Med. 2016 Sep;42(9):1360-73. doi: 10.1007/s00134-016-4400-x. Epub 2016 Jun 22.

  PMID: 27334266 RESULT

• Gattinoni L, Caironi P, Cressoni M, Chiumello D, Ranieri VM, Quintel M, Russo S, Patroniti N, Cornejo R, Bugedo G. Lung recruitment in patients with the acute respiratory distress syndrome. N Engl J Med. 2006 Apr 27;354(17):1775-86. doi: 10.1056/NEJMoa052052.

  PMID: 16641394 RESULT

• Muders T, Luepschen H, Zinserling J, Greschus S, Fimmers R, Guenther U, Buchwald M, Grigutsch D, Leonhardt S, Putensen C, Wrigge H. Tidal recruitment assessed by electrical impedance tomography and computed tomography in a porcine model of lung injury*. Crit Care Med. 2012 Mar;40(3):903-11. doi: 10.1097/CCM.0b013e318236f452.

  PMID: 22202705 RESULT

• Pelosi P, Brazzi L, Gattinoni L. Prone position in acute respiratory distress syndrome. Eur Respir J. 2002 Oct;20(4):1017-28. doi: 10.1183/09031936.02.00401702.

  PMID: 12412699 RESULT

• Pelosi P, Cereda M, Foti G, Giacomini M, Pesenti A. Alterations of lung and chest wall mechanics in patients with acute lung injury: effects of positive end-expiratory pressure. Am J Respir Crit Care Med. 1995 Aug;152(2):531-7. doi: 10.1164/ajrccm.152.2.7633703.

  PMID: 7633703 RESULT

• Blankman P, Hasan D, Erik G, Gommers D. Detection of 'best' positive end-expiratory pressure derived from electrical impedance tomography parameters during a decremental positive end-expiratory pressure trial. Crit Care. 2014 May 10;18(3):R95. doi: 10.1186/cc13866.

  PMID: 24887391 RESULT

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Massimo Antonelli, MD

  Catholic University of the Sacred Heart

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the department of Anesthesia and Intensive care medicine

Model Details: pilot-feasibility study

Study Record Dates

• First Submitted: October 19, 2018
• First Posted: October 25, 2018
• Study Start: October 1, 2018
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: August 4, 2022

Record last verified: 2022-08

Locations

IT (1)