Acute Respiratory Distress Network (ARDSNet) Study 04 Assessment of Low tidal Volume and elevated End-expiratory volume to Obviate Lung Injury (ALVEOLI)
Accession Number
HLB00500606a
Study Type
Clinical Trial
Collection Type
Open BioLINCC Study
See bottom of this webpage for request information
Study Period
1999-2002
NHLBI Division
DLD
Date Prepared
October 13, 2008
Last Updated
August 24, 2006
Clinical Trial URLs
https://clinicaltrials.gov/ct2/s...
Primary Publication URLs
https://www.ncbi.nlm.nih.gov/pub...
Study Website
http://www.ardsnet.org/
Consent
Commercial Use Data Restrictions No
Data Restrictions Based On Area Of Research No
Commercial Use Specimen Restrictions No
Non-Genetic Use Specimen Restrictions Based On Area Of Use No
Genetic Use Of Specimens Allowed? Yes, For Some Specimens
Genetic Use Area Of Research Restrictions No
Objectives
The ARDS Network is a consortium of clinical centers and a coordinating center to design and test novel therapies for the treatment of Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS). The ARDS Network 01/03 trials included an investigation of the efficacy and safety of Ketoconazole and Respiratory Management in the treatment of ALI and ARDS (KARMA). The Ketoconazole arm of the KARMA study was later stopped due to an inability to show efficacy. Patients continued to be randomized to the respiratory management arms of the study (ARMA), which compared two ventilator strategies: a tidal volume of 6 mL/kg versus 12 mL/kg. The LARMA phase of the study investigated the efficacy of Lisofylline and Respiratory Management. The objective of the ALVEOLI study was to compare clinical outcomes of patients with ALI and ARDS treated with a higher end-expiratory lung volume/lower FiO2 versus a lower end-expiratory lung volume/higher FiO2 ventilation strategy. The ALVEOLI study tested the hypothesis that mortality from ALI and ARDS would be reduced with a mechanical ventilation strategy designed to prevent lung injury from repeated collapse of bronchioles and alveoli at end-expiration.
Background
Most patients requiring mechanical ventilation for ALI and ARDS receive positive end-expiratory pressure (PEEP) of 5 to 12 cm of water. Higher PEEP levels may improve oxygenation and reduce ventilator-induced lung injury but may also cause circulatory depression and lung injury from overdistention. PEEP levels higher than traditional levels may reduce ventilator-induced lung injury by decreasing the proportion of nonaerated lung and higher PEEP levels may allow arterial-oxygenation goals to be met at a lower level of inspired oxygen (FiO2).
Subjects
Patients 14 years of age or more, intubated and receiving mechanical ventilation with a sudden decrease in the ratio of the partial pressure of arterial oxygen (PaO2) to FiO2 of 300 or less, recent appearance of bilateral pulmonary infiltrates consistent with the presence of edema, and no evidence of left atrial hypertension. A total of 549 patients were randomized to receive mechanical ventilation with either lower or higher PEEP levels, which were set according to different tables of predetermined combinations of PEEP and fraction of inspired oxygen.
Conclusions
Patients with acute lung injury and ARDS who receive mechanical ventilation with a tidal-volume goal of 6 ml per kilogram of predicted body weight and an end-inspiratory plateau-pressure limit of 30 cm of water, clinical outcomes were statistically similar whether lower or higher PEEP levels are used. (N Engl J Med 2004;351:327-336).
Additional Details
Lower PEEP: 274
Higher PEEP 1, 3: 163
Higher PEEP 2, 4: 113
|
|
Lower PEEP |
Higher PEEP 1,3 |
Higher PEEP 2,4 |
All |
||||
|---|---|---|---|---|---|---|---|---|
|
N |
% |
N |
% |
N |
% |
N |
% |
|
|
16-20 |
13 |
4.74 |
2 |
1.23 |
6 |
5.31 |
21 |
3.82 |
|
21-25 |
6 |
2.19 |
6 |
3.68 |
3 |
2.65 |
15 |
2.73 |
|
26-30 |
20 |
7.30 |
5 |
3.07 |
3 |
2.65 |
28 |
5.09 |
|
31-35 |
27 |
9.85 |
7 |
4.29 |
6 |
5.31 |
40 |
7.27 |
|
36-40 |
31 |
11.31 |
20 |
12.27 |
10 |
8.85 |
61 |
11.09 |
|
41-45 |
33 |
12.04 |
12 |
7.36 |
13 |
11.50 |
58 |
10.55 |
|
46-50 |
31 |
11.31 |
17 |
10.43 |
9 |
7.96 |
57 |
10.36 |
|
51-55 |
25 |
9.12 |
22 |
13.50 |
11 |
9.73 |
58 |
10.55 |
|
56-60 |
12 |
4.38 |
16 |
9.82 |
10 |
8.85 |
38 |
6.91 |
|
61-65 |
19 |
6.93 |
13 |
7.98 |
10 |
8.85 |
42 |
7.64 |
|
66-70 |
24 |
8.76 |
13 |
7.98 |
5 |
4.42 |
42 |
7.64 |
|
71-75 |
13 |
4.74 |
15 |
9.20 |
9 |
7.96 |
37 |
6.73 |
|
76-80 |
13 |
4.74 |
8 |
4.91 |
8 |
7.08 |
29 |
5.27 |
|
81-85 |
5 |
1.82 |
5 |
3.07 |
6 |
5.31 |
16 |
2.91 |
|
86-90 |
2 |
0.73 |
2 |
1.23 |
4 |
3.54 |
8 |
1.45 |
|
|
Lower PEEP |
Higher PEEP 1,3 |
Higher PEEP 2,4 |
All |
||||
|---|---|---|---|---|---|---|---|---|
|
N |
% |
N |
% |
N |
% |
N |
% |
|
|
Female |
145 |
52.92 |
89 |
54.60 |
68 |
60.18 |
302 |
54.91 |
|
Male |
129 |
47.08 |
74 |
45.40 |
45 |
39.82 |
248 |
45.09 |
|
|
Lower PEEP |
Higher PEEP 1,3 |
Higher PEEP 2,4 |
All |
||||
|---|---|---|---|---|---|---|---|---|
|
N |
% |
N |
% |
N |
% |
N |
% |
|
|
White non-Hispanic |
201 |
73.36 |
121 |
74.23 |
91 |
80.53 |
413 |
75.09 |
|
Black non-Hispanic |
39 |
14.23 |
25 |
15.34 |
13 |
11.50 |
77 |
14.00 |
|
Other |
34 |
12.41 |
17 |
10.43 |
9 |
7.96 |
60 |
10.91 |
Please note that biospecimen availability is subject to review by the NHLBI, BioLINCC, and the NHLBI Biorepository. Certain biospecimens may not be made available for your request. Section 3 of the BioLINCC handbook describes the components of the review process
Requests for Open BioLINCC Studies are submitted through this website. Click the Request button to begin.
Resources Available
Specimens and Study DatasetsMaterials Available
- Plasma
- More Details
Study Documents
Persons using assistive technology may not be able to fully access information in the study documents. For assistance, Contact BioLINCC and include the web address and/or publication title in your message. If you need help accessing information in different file formats such as PDF, XLS, DOC, see Instructions for Downloading Viewers and Players.