Work of Breathing and Mechanical Ventilation in Acute Lung Injury

NCT00961168 | Withdrawn

• 1 other identifier: WOBARDS
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary goal of this study is to measure changes in biological markers of inflammation in critically-ill patients with acute lung injury (ALI) or acute respiratory distress syndrome (ARDS) while they are treated with different styles of lung-protective, artificial breathing assistance. Secondary goals are to measure the breathing effort of patients using different artificial breathing patterns from the breathing machine. The primary hypothesis is that volume-targeted artificial patterns will produce less inflammation. The secondary hypothesis is that volume-targeted artificial patterns will increase breathing effort compared to pressure-targeted artificial patterns.

Conditions

Acute Lung Injury

Keywords

Mechanical Ventilation

Outcome Measures

Primary Outcomes (1)

• proinflammatory cytokine expression in plasma

  2 hours

Secondary Outcomes (1)

• work of breathing

  2 hours

Study Arms (1)

Lung-Protective Ventilation

EXPERIMENTAL

Lung-Protective Ventilation comparing volume vs. pressure control

Other: Volume Control Ventilation; Other: Pressure Control Ventilation

Interventions

Volume Control Ventilation OTHER

Mechanical ventilation at a constant tidal volume of 6 mL/kg.

Also known as: Volume Assist/Control

Lung-Protective Ventilation

Pressure Control Ventilation OTHER

Mechanical ventilation at a constant airway pressure of 25-30 cm H2O

Also known as: Pressure Assist/Control

Lung-Protective Ventilation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both medical and surgical patients undergoing mechanical ventilatory support who meet criteria for Acute Lung Injury (ALI) or Acute Respiratory Distress Syndrome (ARDS) as defined by the European-American Consensus Conference,
• Mechanical ventilation via an endotracheal or tracheotomy tube,
• PaO2/FiO2 \< 300 mmHg with bilateral infiltrates on chest radiogram,
• Clinical management with lung protective ventilation (Tidal volume \< 8 mL/kg).

You may not qualify if:

• Patients receiving "comfort care",
• High cervical spinal cord injury or other neuromuscular disease,
• Prisoners,
• Pregnancy,
• Less than 18 years of age,
• Facial fractures and coagulopathies,
• Patients placed on psychiatric hold.

Sponsors & Collaborators

• University of California, San Francisco: lead

Related Publications (16)

• 1. Dreyfus D, Sauman G. Ventilation induced injury. In: Principles and Practice of Mechanical Ventilation. Tobin M J. Editor. New York: McGraw Hill Publishers; 1994: 793-811.

  BACKGROUND

• Hickling KG. Ventilatory management of ARDS: can it affect the outcome? Intensive Care Med. 1990;16(4):219-26. doi: 10.1007/BF01705155.

  PMID: 2193041 BACKGROUND

• Fu Z, Costello ML, Tsukimoto K, Prediletto R, Elliott AR, Mathieu-Costello O, West JB. High lung volume increases stress failure in pulmonary capillaries. J Appl Physiol (1985). 1992 Jul;73(1):123-33. doi: 10.1152/jappl.1992.73.1.123.

  PMID: 1506359 BACKGROUND

• Carlton DP, Cummings JJ, Scheerer RG, Poulain FR, Bland RD. Lung overexpansion increases pulmonary microvascular protein permeability in young lambs. J Appl Physiol (1985). 1990 Aug;69(2):577-83. doi: 10.1152/jappl.1990.69.2.577.

  PMID: 2228868 BACKGROUND

• Lachmann B, Jonson B, Lindroth M, Robertson B. Modes of artificial ventilation in severe respiratory distress syndrome. Lung function and morphology in rabbits after wash-out of alveolar surfactant. Crit Care Med. 1982 Nov;10(11):724-32. doi: 10.1097/00003246-198211000-00005. No abstract available.

  PMID: 6754260 BACKGROUND

• 6. Tuxen DV. Permisive hypercapnia. In: Principles and Practice of Mechanical Ventilation. Tobin M J. Editor. New York: McGraw Hill Publishers; 1994: 371-392.

  BACKGROUND

• 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 BACKGROUND

• Ranieri VM, Suter PM, Tortorella C, De Tullio R, Dayer JM, Brienza A, Bruno F, Slutsky AS. Effect of mechanical ventilation on inflammatory mediators in patients with acute respiratory distress syndrome: a randomized controlled trial. JAMA. 1999 Jul 7;282(1):54-61. doi: 10.1001/jama.282.1.54.

  PMID: 10404912 BACKGROUND

• Stuber F, Wrigge H, Schroeder S, Wetegrove S, Zinserling J, Hoeft A, Putensen C. Kinetic and reversibility of mechanical ventilation-associated pulmonary and systemic inflammatory response in patients with acute lung injury. Intensive Care Med. 2002 Jul;28(7):834-41. doi: 10.1007/s00134-002-1321-7. Epub 2002 Jun 15.

  PMID: 12122519 BACKGROUND

• Tuxen DV. Permissive hypercapnic ventilation. Am J Respir Crit Care Med. 1994 Sep;150(3):870-4. doi: 10.1164/ajrccm.150.3.8087364. No abstract available.

  PMID: 8087364 BACKGROUND

• Kallet RH, Campbell AR, Dicker RA, Katz JA, Mackersie RC. Work of breathing during lung-protective ventilation in patients with acute lung injury and acute respiratory distress syndrome: a comparison between volume and pressure-regulated breathing modes. Respir Care. 2005 Dec;50(12):1623-31.

  PMID: 16318643 BACKGROUND

• Dreyfuss D, Soler P, Basset G, Saumon G. High inflation pressure pulmonary edema. Respective effects of high airway pressure, high tidal volume, and positive end-expiratory pressure. Am Rev Respir Dis. 1988 May;137(5):1159-64. doi: 10.1164/ajrccm/137.5.1159.

  PMID: 3057957 BACKGROUND

• Mascheroni D, Kolobow T, Fumagalli R, Moretti MP, Chen V, Buckhold D. Acute respiratory failure following pharmacologically induced hyperventilation: an experimental animal study. Intensive Care Med. 1988;15(1):8-14. doi: 10.1007/BF00255628.

  PMID: 3230208 BACKGROUND

• Gattinoni L, Pesenti A. The concept of "baby lung". Intensive Care Med. 2005 Jun;31(6):776-84. doi: 10.1007/s00134-005-2627-z. Epub 2005 Apr 6.

  PMID: 15812622 BACKGROUND

• Froese AB, Bryan AC. Effects of anesthesia and paralysis on diaphragmatic mechanics in man. Anesthesiology. 1974 Sep;41(3):242-55. doi: 10.1097/00000542-197409000-00006. No abstract available.

  PMID: 4604401 BACKGROUND

• Myers TR, MacIntyre NR. Respiratory controversies in the critical care setting. Does airway pressure release ventilation offer important new advantages in mechanical ventilator support? Respir Care. 2007 Apr;52(4):452-8; discussion 458-60.

  PMID: 17417979 BACKGROUND

MeSH Terms

Conditions

Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Mitchell Cohen, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 16, 2009
• First Posted: August 18, 2009
• Study Start: September 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2013
• Last Updated: March 5, 2015

Record last verified: 2015-03