Trial record 11 of 404 for:    "Acute respiratory distress syndrome"

Airway Pressure Release Ventilation in Acute Lung Injury

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Johns Hopkins University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00750204
First received: September 9, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Acute Lung Injury
Acute Respiratory Distress Syndrome
Mechanical Ventilation
Device: APRV
Device: Conventional MV
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Airway Pressure Release Ventilation in Acute Lung Injury

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Amount of sedatives used [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cytokine levels in the blood and lungs [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: July 2008
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: APRV
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

APRV Protocol

  • Set 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.
  • Phigh = the inspiratory plateau pressure. Maximum Phigh = 30 cm H20.
  • Plow = 5 cm H2O. Adjust Plow to achieve pressure release volumes 5.5-6.5 ml/kg of 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 Phigh in increments of 2-4 cm H20 to achieve desired release volumes (minimum Phigh = 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.
Other Names:
  • Lung-protective ventilation
  • Airway Pressure Release Ventilation
Active Comparator: Conventional MV
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
Low tidal-volume mechanical ventilation
Other Names:
  • Lung protective ventilation
  • conventional mechanical ventilation

Detailed Description:

Acute respiratory failure is common in patients with acute lung injury. MV re-establishes adequate gas exchange; it allows time for administration of antibiotics, for the host's immune system to fight infections, and for natural healing. Approximately 60% of ALI patients survive to hospital discharge (1). However, conventional approaches to MV in ALI frequently cause dysynchrony between a patient's spontaneous respiratory efforts and the ventilator's respiratory cycle (2;3). Dysynchrony causes discomfort, anxiety, and agitation. To manage dysynchrony, physicians frequently prescribe large doses of sedative and analgesic medications. These medications contribute to delirium and sleep deprivation during the critical illness, and may delay weaning from MV and discharge from the intensive care unit (2;4). They may also contribute significantly to neuromuscular and neurocognitive sequelae after recovery from ALI (5;6). Moreover, MV may itself cause additional lung injury (ventilator-induced lung injury, VILI) which could, paradoxically, delay or prevent recovery from respiratory failure in some ALI patients (7;9).

Airway pressure release ventilation (APRV) is a mode of MV that is designed to reduce patient-ventilator dysynchrony and VILI. It differs from most other modes of MV in that it allows patients to breathe spontaneously at any time, independent of the ventilator's cycle. This feature may improve breathing comfort by minimizing patient-ventilator dysynchrony. Improving comfort and reducing agitation may ultimately curtail the use of sedative and analgesic medications. Since a substantial proportion of ventilation results from the patient's spontaneous efforts independent of the ventilator cycle, the frequency of mechanically assisted breaths can be reduced. This may reduce VILI from the cyclic opening-closing of alveoli and small bronchioles that results from assisted MV breaths. Another feature of APRV that distinguishes it from other modes of MV is that it applies a sustained high pressure during inspiration and a brief period of lower pressure during exhalation. This approach may maximize and maintain alveolar recruitment throughout the ventilatory cycle while limiting high airway pressures, thus further reducing VILI. Moreover, spontaneous contractions of the diaphragm during APRV may open dependent atelectatic lung regions, improving ventilation-perfusion (V/Q) matching and gas exchange. However, these potential advantages of APRV are unproven.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Acute onset of:

  1. PaO2 / FiO2 ≤ 300
  2. Bilateral infiltrates consistent with pulmonary edema on frontal chest radiograph. The infiltrates may be patchy, diffuse, homogeneous, or asymmetric
  3. Requirement for positive pressure ventilation via endotracheal tube, and
  4. No clinical evidence of left atrial hypertension.
  5. Receiving conventional MV, or LPV, in the AC mode with 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.

Exclusion Criteria:

  1. FiO2 > 70% or PaO2/FiO2 < 125 or arterial pH < 7.25
  2. Greater than 6 days since all inclusion criteria are met
  3. Anticipated to begin weaning from MV within 48 hours
  4. Neuromuscular disease that prevents the ability to generate spontaneous tidal volumes.
  5. Glasgow Coma Scale (GCS) < 15 within 1 week of intubation
  6. Acute stroke (vascular occlusion or hemorrhage)
  7. Current alcoholism or previous daily use of opioids or benzodiazepines before hospitalization
  8. Acute meningitis or encephalitis
  9. Pregnancy (negative pregnancy test required for women of child-bearing potential) or breast-feeding.
  10. Severe chronic respiratory disease
  11. Previous barotraumas during the current hospitalization
  12. Clinical evidence of bronchoconstriction on bedside examination (i.e., wheezing).
  13. Patient, surrogate, or physician not committed to full support
  14. Severe chronic liver disease (Child-Pugh Score B or C)
  15. INR > 2.0
  16. Platelet level < 50,000
  17. Mean arterial pressure < 65, or patient receiving intravenous vasopressors (any dose of epinephrine, norepinephrine, phenylephrine, or dopamine > 5 mcg/kg/min)
  18. Age < 16 years old
  19. Morbid obesity (greater than 1kg/cm body weight).
  20. No consent/inability to obtain consent
  21. Unwillingness of the clinical team to use conventional low tidal-volume protocol for MV.
  22. Moribund patient not expected to survive 24 hours.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00750204

Contacts
Contact: Roy G Brower, M.D. 410-955-3467 rbrower@mail.jhmi.edu
Contact: Martin F Britos, M.D. 410-955-3467 mbritos1@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Hospital Medical Intensive Care Unit Recruiting
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Roy G Brower, M.D. Johns Hopkins University
  More Information

Publications:

Responsible Party: Roy G. Brower, M.D./Principal Investigator, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00750204     History of Changes
Other Study ID Numbers: NA_00017371
Study First Received: September 9, 2008
Last Updated: September 9, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Acute Lung Injury
Acute Respiratory Distress Syndrome
ALI
ARDS
Mechanical Ventilation
Sedation
Critical Illness
Ventilator Induced Lung Injury
VILI
Cytokines
Protective Ventilation
Airway Pressure Release Ventilation
APRV
Breathing Comfort
Dyssynchrony
Asynchrony

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Respiratory Distress Syndrome, Newborn
Lung Injury
Wounds and Injuries
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries

ClinicalTrials.gov processed this record on August 28, 2014