Осциллярная вентиляция
Применение сурфактанта у взрослых с ARDS
2004;351:884-92.
HL 10 one versus three dosages in ALI/ARDS
J. Kesecioglu, MJ Schultz, J Maas, RB de Wilde, E Steenken, B Lachmann
•Multicentre, open, randomised, parallel, prospective, phase IIb study
•Patients randomised to receive either 1 dosage or 3 dosages
•Primary objective: To evaluate the efficacy and safety of 3 dosages of HL 10 compared to a single dose
Baseline characteristics of the patients (means ±
SD) |
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HL 10 |
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HL 10 |
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Statistical |
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significanc |
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SCORES |
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1 dosage |
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3 dosages |
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e |
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(N = 9) |
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(N = 14) |
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(P value) |
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SAPS II |
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41.9 |
+ 15.0 |
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45.4 |
+ 12.0 |
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0.45 1) |
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SAPS II predicted mortality (%) |
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32.5 |
+ 26.8 |
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37.9 |
+ 22.6 |
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0.45 1) |
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LODS |
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6.8 |
+ 2.8 |
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6.9 |
+ 3.1 |
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0.97 1) |
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LODS predicted mortality (%) |
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39.9 |
+ 22.2 |
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40.5 |
+ 25.0 |
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0.97 1) |
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APACHE II |
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22.3 + 7.3 |
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23.9 + 5.8 |
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0.70 1) |
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APACHE II predicted mortality (%) |
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40.6 |
+ 28.8 |
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50.3 |
+ 23.1 |
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0.45 1) |
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Mortality at Day 29 (%) |
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33.3 |
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14.3 |
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0.34 2) |
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1)Wicoxon test, between group probability
2)Fisher’s exact test
Instillation of HL 10
•Clamp the intubation tube at expiratory hold
•Disconnect the ventilator from the patient; connect the syringe to the tube; open the clamp; give the HL 10 as fast as possible
•Re-clamp the tube; re-connect the patient to the mechanical ventilator
Positioning of the patient mustbe done with care
Secondary objectives
•Days on ventilation at Day 28.
•Days alive and off ventilator at Day 28.
•Days alive and out of ICU at Day 28.
•Changes in PaO2/FiO2 ratio and other relevant lung parameters.
•Change in SOFA score.
•Dead/alive at discharge from ICU followed until Day 90.
•Dead/alive at discharge from hospital followed until Day 90.