EBQ:ARDSnet Trial: Difference between revisions
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| fulltexturl=http://www.nejm.org/doi/full/10.1056/NEJM200005043421801 | | fulltexturl=http://www.nejm.org/doi/full/10.1056/NEJM200005043421801 | ||
| pdfurl=http://www.nejm.org/doi/pdf/10.1056/NEJM200005043421801 | | pdfurl=http://www.nejm.org/doi/pdf/10.1056/NEJM200005043421801 | ||
| status=Complete | |||
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==Conclusion== | ==Conclusion== | ||
In patients with ALI/ARDS, lower tidal volumes of 6mL/kg | In patients with ALI/ARDS, lower tidal volumes of 6mL/kg predicted body weight reduces mortality and decreases length of time on mechanical ventilation. | ||
==Major Points== | ==Major Points== | ||
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*The trial was stopped early when patients in the low tidal volumes arm showed a significant decrease in mortality and more ventilator-free days compared to the traditional tidal volumes arm. | *The trial was stopped early when patients in the low tidal volumes arm showed a significant decrease in mortality and more ventilator-free days compared to the traditional tidal volumes arm. | ||
==Guidelines== | ==Guidelines== | ||
See [[ | See [[Sepsis]] for guideline recommendations | ||
==Design== | ==Design== | ||
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===Baseline Characteristics=== | ===Baseline Characteristics=== | ||
*Mean age: 51.5 years | *Mean age: 51.5 years | ||
* | *Sex: Female (40.5%) | ||
*Ethnicity: | *Ethnicity: | ||
**White: 73% | **White: 73% | ||
Line 72: | Line 73: | ||
Patients monitored until day 28 or death for signs of system failure: | Patients monitored until day 28 or death for signs of system failure: | ||
*Circulatory failure: SBP ≤90mmHg or need for vasopressor | *Circulatory failure: SBP ≤90mmHg or need for vasopressor | ||
*Coagulation failure: | *Coagulation failure: Platelets ≤80,000 mm3 | ||
*Hepatic failure: | *Hepatic failure: Bilirubin ≥2mg/dL | ||
*Renal failure: | *Renal failure: Creatinine ≥2mg/dL | ||
==Outcomes== | ==Outcomes== | ||
===Primary Outcomes=== | ===Primary Outcomes=== | ||
*180-day mortality | |||
**31.0% vs. 39.8% (RR 0.78; P=0.007) | |||
*Ventilator-free days (Days 1-28) | |||
**12 vs. 10 (P=0.007) | |||
*Breathing without assistance by day 28 | |||
**65.7% vs. 55.0% (P<0.001; NNT 9) | |||
===Secondary Outcomes=== | ===Secondary Outcomes=== | ||
*Days w/o non-pulmonary organ or system failure (Days 1 to 28) | |||
**15 vs. 12 (P=0.006) | |||
*Days w/o circulatory failure | |||
**19 vs. 17 (P=0.004) | |||
*Days w/o coagulation failure | |||
**21 vs. 19 (P=0.004) | |||
*Days w/o renal failure | |||
**20 vs. 18 (P=0.005) | |||
*Barotrauma (New PTX, pneumomediastinum, subcutaneous emphysema, pneumatocele) | |||
**10% vs. 11% (P=0.43) | |||
*Mean tidal volumes (ml/kg PBW) | |||
**6.2 vs. 11.8 (P<0.001) | |||
*Mean plateau pressures (cm H2O) | |||
**25 vs. 33 (P<0.001) | |||
*Peak inspiratory pressures (cm H2O) | |||
**32 vs. 39 (P<0.05) | |||
==Criticisms== | ==Criticisms== | ||
Line 86: | Line 109: | ||
==Funding== | ==Funding== | ||
The National Heart, Lung, and Blood Institute. | The National Heart, Lung, and Blood Institute. | ||
==Sources== | ==Sources== | ||
<references/> | <references/> | ||
[[Category: | [[Category:Pulmonary]][[Category:Critical Care]][[Category:EBQ]] |
Revision as of 02:19, 14 July 2016
PubMed Full text PDF
Clinical Question
Does a lung protective strategy of low tidal volumes in patients with Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS) decrease mortality and ventilator-free days when compared to traditional ventilation strategies.
Conclusion
In patients with ALI/ARDS, lower tidal volumes of 6mL/kg predicted body weight reduces mortality and decreases length of time on mechanical ventilation.
Major Points
- Acute Respiratory Distress Syndrome results from alveolar damage and barotrauma are associated with elevated plateau pressures and higher tidal volume ventilations
- The trial was stopped early when patients in the low tidal volumes arm showed a significant decrease in mortality and more ventilator-free days compared to the traditional tidal volumes arm.
Guidelines
See Sepsis for guideline recommendations
Design
- Multicenter, randomized trial of 861 patients in parallel-group in 10 university-affiliated ARDSNet centers
- Low tidal volumes: Starting at 6ml/kg PBW and plateau pressure ≤30cmH2O (n=432)
- Traditional tidal volumes: starting at 12ml/kg PBW and plateau pressure of ≤50cmH2O (n=429)
- Enrollment: March 1996 to March 1999 (terminated early after the fourth interim analysis)
- Follow-up: 180 days or until home breathing independently
Population
Inclusion Criteria
- Age ≥18 years
- Receiving mechanical ventilation
- Diagnosis of ALI/ARDS ≤36h prior to enrollment; defined as:
- Acute decrease in PaO2/FiO2ratio to ≤300
- CXR: Bilateral pulmonary infiltrates
- PCWP of ≤18mmHg without evidence of left atrial hypertension
Exclusion Criteria
- Pregnancy
- Increased ICP, neuromuscular disease imparing spontaneous breathing, sickle cell disease, or severe chronic respiratory disease
- Weight more than 1kg/cm of height
- Burns >30% of BSA
- Estimated 6-month mortality rate >50%
- History of bone marrow or lung transplantation
- Child-Pugh class C liver disease
- Participation in other trials w/in 30 days
Baseline Characteristics
- Mean age: 51.5 years
- Sex: Female (40.5%)
- Ethnicity:
- White: 73%
- Black: 17.5%
- Hispanic: 6%
- APACHE III score: 82.5
- Mean PaO2:FiO2: 136
- Mean tidal volume: 670 mL
- Mean minute ventilation: 13.4 vs. 12.7 L/min (P=0.01)
Interventions
Patients randomly assigned to receive mechanical ventilation (volume-assist-control mode) with following strategies for tidal volume:
- Low tidal volumes (lung protective strategy): Starting at 6ml/kg PBW to maintain plateau pressure ≤30cm H2O (n=432)
- Traditional tidal volumes: Starting at 12ml/kg to maintain plateau pressure of ≤50cm H2O (n=429)
Patients monitored until day 28 or death for signs of system failure:
- Circulatory failure: SBP ≤90mmHg or need for vasopressor
- Coagulation failure: Platelets ≤80,000 mm3
- Hepatic failure: Bilirubin ≥2mg/dL
- Renal failure: Creatinine ≥2mg/dL
Outcomes
Primary Outcomes
- 180-day mortality
- 31.0% vs. 39.8% (RR 0.78; P=0.007)
- Ventilator-free days (Days 1-28)
- 12 vs. 10 (P=0.007)
- Breathing without assistance by day 28
- 65.7% vs. 55.0% (P<0.001; NNT 9)
Secondary Outcomes
- Days w/o non-pulmonary organ or system failure (Days 1 to 28)
- 15 vs. 12 (P=0.006)
- Days w/o circulatory failure
- 19 vs. 17 (P=0.004)
- Days w/o coagulation failure
- 21 vs. 19 (P=0.004)
- Days w/o renal failure
- 20 vs. 18 (P=0.005)
- Barotrauma (New PTX, pneumomediastinum, subcutaneous emphysema, pneumatocele)
- 10% vs. 11% (P=0.43)
- Mean tidal volumes (ml/kg PBW)
- 6.2 vs. 11.8 (P<0.001)
- Mean plateau pressures (cm H2O)
- 25 vs. 33 (P<0.001)
- Peak inspiratory pressures (cm H2O)
- 32 vs. 39 (P<0.05)
Criticisms
Funding
The National Heart, Lung, and Blood Institute.