Airway Pressure Release Ventilation in Acute Lung Injury

NCT00750204 | Terminated Results

• 1 other identifier: NA_00017371
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare airway pressure release ventilation (APRV) to conventional mechanical ventilation (MV) in patients with acute lung injury (ALI) to determine if APRV can reduce agitation, delirium, and requirements for sedative medications. We will also compare markers of inflammation in the blood and lung to determine if APRV reduces ventilator-induced lung injury (VILI), compared to conventional mechanical ventilation. The proposed study is a randomized, crossover trial. We plan to enroll 40 patients with ALI and randomize to APRV or conventional MV for 24 hours. After this time the patients will be switched to the alternative mode of ventilation (MV or APRV) for another 24 hours. To assess breathing comfort, at the end of each 24-hour period we will measure the amounts of sedative and analgesic medications used. We will also measure the concentrations of markers of inflammation in the blood and lung as measures of VILI. Finally, throughout the study we will compare the adequacy of gas exchange with APRV compared to conventional MV.

Conditions

Acute Lung Injury; Acute Respiratory Distress Syndrome; Mechanical Ventilation

Keywords

Acute Lung Injury; ALI; Acute Respiratory Distress Syndrome; Mechanical Ventilation; Sedation; Critical Illness; Ventilator Induced Lung Injury; VILI; Cytokines; Protective Ventilation; Airway Pressure Release Ventilation; APRV; Breathing Comfort; Dyssynchrony; Asynchrony

Outcome Measures

Primary Outcomes (1)

• Amount of Sedatives Used

  48 hours

Study Arms (2)

APRV

EXPERIMENTAL

Patients will be randomized to either arm. After 24 hours they will crossover to the alternative arm of the study for an additional 24 hours. After a total of 48 hours (24 hours in each study arm) the study will conclude.

Device: APRV

Conventional MV

ACTIVE COMPARATOR

Patients will be randomized to either arm. After 24 hours they will crossover to the alternative arm of the study for an additional 24 hours. After a total of 48 hours (24 hours in each study arm) the study will conclude.

Device: Conventional MV

Interventions

APRV DEVICE

APRV Protocol * Set fraction of inspired oxygen (FiO2) at 0.1 higher than the setting on conventional MV currently used * Tlow = 1.0 second (this setting shall remain unchanged throughout the trial). * Respiratory rate (RR) to equal 60-65% of RR on conventional MV. * P high = the inspiratory plateau pressure. Maximum P high = 30 cm H20. * Plow = 5 cm water (H2O). Adjust Plow to achieve pressure release volumes 5.5-6.5 ml/kg of percent body weight (PBW). * If release volumes on APRV are greater than desired, increase Plow by 2-4 cm H2O increments to a maximum of Plow = 12 cm H2O. If release volumes are larger than desired despite raising Plow to 12 cm H20, decrease P high in increments of 2-4 cm H20 to achieve desired release volumes (minimum P high = 12 cm H20). If release volumes on APRV still remain larger than desired,the participant will be excluded from the study and placed on conventional MV.

Also known as: Lung-protective ventilation, Airway Pressure Release Ventilation

APRV

Conventional MV DEVICE

Low tidal-volume mechanical ventilation

Also known as: Lung protective ventilation, conventional mechanical ventilation

Conventional MV

Eligibility Criteria

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

You may qualify if:

• Acute onset of:
• Arterial Pressure of Oxygen (PaO2) / FiO2 ≤ 300
• Bilateral infiltrates consistent with pulmonary edema on frontal chest radiograph. The infiltrates may be patchy, diffuse, homogeneous, or asymmetric
• Requirement for positive pressure ventilation via endotracheal tube, and
• No clinical evidence of left atrial hypertension.
• Receiving conventional MV, or lung-protective ventilation (LPV), in the assist control (AC) mode with positive end-expiratory pressure (PEEP) \> 5 cm H2O Criteria 1-3 must occur within a 24-hour period. "Acute onset" is defined as follows: the duration of the hypoxemia criterion (#1) and the chest radiograph criterion (#2) must be \< 7 days at the time of randomization.

You may not qualify if:

• FiO2 \> 70% or PaO2/FiO2 \< 125 or arterial pH \< 7.25
• Anticipated to begin weaning from MV within 48 hours
• Neuromuscular disease that prevents the ability to generate spontaneous tidal volumes.
• Glasgow Coma Scale (GCS) \< 15 within 1 week of intubation
• Acute stroke (vascular occlusion or hemorrhage)
• Current alcoholism or previous daily use of opioids or benzodiazepines before hospitalization
• Acute meningitis or encephalitis
• Pregnancy (negative pregnancy test required for women of child-bearing potential) or breast-feeding.
• Severe chronic respiratory disease
• Previous barotraumas during the current hospitalization
• Clinical evidence of bronchoconstriction on bedside examination (i.e., wheezing).
• Patient, surrogate, or physician not committed to full support
• Severe chronic liver disease (Child-Pugh Score B or C)
• International Normalized Ratio (INR) \> 2.0
• Platelet level \< 50,000

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital Medical Intensive Care Unit

Baltimore, Maryland, 21205, United States

Location

Related Publications (9)

• Rubenfeld GD, Caldwell E, Peabody E, Weaver J, Martin DP, Neff M, Stern EJ, Hudson LD. Incidence and outcomes of acute lung injury. N Engl J Med. 2005 Oct 20;353(16):1685-93. doi: 10.1056/NEJMoa050333.

  PMID: 16236739 BACKGROUND

• Sassoon CS, Foster GT. Patient-ventilator asynchrony. Curr Opin Crit Care. 2001 Feb;7(1):28-33. doi: 10.1097/00075198-200102000-00005.

  PMID: 11373508 BACKGROUND

• Thille AW, Rodriguez P, Cabello B, Lellouche F, Brochard L. Patient-ventilator asynchrony during assisted mechanical ventilation. Intensive Care Med. 2006 Oct;32(10):1515-22. doi: 10.1007/s00134-006-0301-8. Epub 2006 Aug 1.

  PMID: 16896854 BACKGROUND

• Cooper AB, Thornley KS, Young GB, Slutsky AS, Stewart TE, Hanly PJ. Sleep in critically ill patients requiring mechanical ventilation. Chest. 2000 Mar;117(3):809-18. doi: 10.1378/chest.117.3.809.

  PMID: 10713011 BACKGROUND

• Herridge MS, Cheung AM, Tansey CM, Matte-Martyn A, Diaz-Granados N, Al-Saidi F, Cooper AB, Guest CB, Mazer CD, Mehta S, Stewart TE, Barr A, Cook D, Slutsky AS; Canadian Critical Care Trials Group. One-year outcomes in survivors of the acute respiratory distress syndrome. N Engl J Med. 2003 Feb 20;348(8):683-93. doi: 10.1056/NEJMoa022450.

  PMID: 12594312 BACKGROUND

• Hopkins RO, Weaver LK, Pope D, Orme JF, Bigler ED, Larson-LOHR V. Neuropsychological sequelae and impaired health status in survivors of severe acute respiratory distress syndrome. Am J Respir Crit Care Med. 1999 Jul;160(1):50-6. doi: 10.1164/ajrccm.160.1.9708059.

  PMID: 10390379 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

• Amato MB, Barbas CS, Medeiros DM, Magaldi RB, Schettino GP, Lorenzi-Filho G, Kairalla RA, Deheinzelin D, Munoz C, Oliveira R, Takagaki TY, Carvalho CR. Effect of a protective-ventilation strategy on mortality in the acute respiratory distress syndrome. N Engl J Med. 1998 Feb 5;338(6):347-54. doi: 10.1056/NEJM199802053380602.

  PMID: 9449727 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

MeSH Terms

Conditions

Acute Lung Injury; Respiratory Distress Syndrome; Critical Illness; Ventilator-Induced Lung Injury

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Results Point of Contact

• Title: Roy Brower, M.D.
• Organization: Johns Hopkins University School of Medicine

rbrower@jhmi.edu

1 (410) 614-6292

Study Officials

• Roy G Brower, M.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: September 9, 2008
• First Posted: September 10, 2008
• Study Start: July 1, 2008
• Primary Completion: October 15, 2008
• Study Completion: October 15, 2008
• Last Updated: May 15, 2017
• Results First Posted: May 15, 2017

Record last verified: 2017-04

Locations

US (1)