Articles: respiratory-distress-syndrome.
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Am. J. Respir. Crit. Care Med. · Feb 1994
Randomized Controlled Trial Comparative Study Clinical TrialRandomized clinical trial of pressure-controlled inverse ratio ventilation and extracorporeal CO2 removal for adult respiratory distress syndrome.
The impact of a new therapy that includes pressure-controlled inverse ratio ventilation followed by extracorporeal CO2 removal on the survival of patients with severe ARDS was evaluated in a randomized controlled clinical trial. Computerized protocols generated around-the-clock instructions for management of arterial oxygenation to assure equivalent intensity of care for patients randomized to the new therapy limb and those randomized to the control, mechanical ventilation limb. We randomized 40 patients with severe ARDS who met the ECMO entry criteria. ⋯ We conclude that there was no significant difference in survival between the mechanical ventilation and the extracorporeal CO2 removal groups. We do not recommend extracorporeal support as a therapy for ARDS. Extracorporeal support for ARDS should be restricted to controlled clinical trials.
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Am. J. Respir. Crit. Care Med. · Feb 1994
Editorial Comment Randomized Controlled Trial Comparative Study Clinical TrialAn anecdote is an anecdote is an anecdote ... but a clinical trial is data.
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Reported survival rates for severe adult respiratory distress syndrome (ARDS) patients vary from 9% to 84%. Animal study results have suggested that application of the high pressures needed to deliver commonly used tidal volumes (10 to 15 mL/kg) may induce an overexpansion of the remaining small fraction of compliant ARDS lung still capable of gas exchange. Conventional ventilatory therapy might thus superimpose an iatrogenic lung injury on the ARDS lung. ⋯ By standardizing therapy, protocols may significantly reduce the random and nonrandom noise (bias) introduced into the clinical environment by clinical care team members. This is especially important fo the many pertinent clinical questions addressed by clinical trials that cannot be double blinded. Conclusions from protocol-controlled clinical trials should be more credible and more likely to lead to action than those of the past.