Non-invasive ventilation in elderly patients with acute hypercapnic respiratory failure: a randomized controlled trial.

Background Older patients usually receive less invasive and costly hospital care, especially if they meet the criteria for Intensive Care Unit (ICU) admission or have a ‘do not intubate’(DNI) order. Objective: The aim of this randomized, control trial was to assess the effectiveness of non-invasive mechanical ventilation (NIV) vs standard medical therapy (SMT) in reducing the need of intubation, improving survival and reducing respiratory distress in very old patients with acute hypercapnic respiratory failure.Methods: Eighty-two patients aged >75 years (mean age 81.3±3.5 years) with acute hypercapnic respiratory failure were randomized to receive NIV or SMT Results: primary outcome was the need of meeting the intubation criteria (ETIc);secondary outcomes were: 12-months mortality “history”; respiratory rate, dyspnea score, and arterial blood gases.Meeting the ETIc was lower in the NIV in comparison with SMT group (7.3 vs. 63.4% of patients, respectively; p<0.001), as well as the mortality risk (OR=0.40; 95%CI: 0.19-0.83; p=0.014). 22/41 SMT patients with DNI received NIV as a “rescue” therapy. The risk of death in this latter group was comparable with the NIV group and significantly lower than in those patients receiving ETI(OR=0.60, 95%CI: 0.18-1.92 vs. 4.03, 95%CI: 2.35-6.94, respectively; p=0.009). Arterial blood gases, respiratory rate and dyspnoea improved significantly faster with NIV than with SMT.Conclusions Compared to SMT, NIV decreased the meeting of ETIc, and the mortality “history” of very old patients with AHRF. NIV should be offered as an alternative to patients considered poor candidates for intubation and those with a DNI order.NCT00600639 at: www.ClinicalTrials.gov