Background and Goal of Study: Very limited data are available about safety and efficacy of sedation during NIPPV. Care for uncooperative patients with ARF can be challenging, leading to high rate of potentially preventable intubations. Goal of study was to assess safety and efficacy of dexmedetomidine sedation during NIPPV in awake uncooperative patients with ARF in ICU settings.

Materials and Methods: 67 adults (18-82 years, mean 64,4±19,7 years), admitted to ICU due to respiratory failure (PaO2<80 mm Hg OR SpO2<90% on room air OR PaCO2>50 mm Hg) were enrolled. Other inclusion criteria were: wakefulness (Glasgow Coma Scale (GCS) score>13), lack of cooperation or agitation (RASS) score >+2) prior to initiation or immediately after initiation of NIPPV. Leading causes of respiratory failure were community-acquired pneumonia (n=32, 47,8%), COPD exacerbation (n=27, 40,3%) and other (n=8, 11,9%). Patients were randomized either to dexmedetomidine sedation (n=36) or control (n=31) group. Investigators were not blinded. Primary endpoint was an intubation rate. Secondary end-points were ICU length of stay (LOS), gas exchange variables (PaO2, PaCO2), new onset hemodynamic instability, vomiting or gastric aspiration events. Study subjects were observed for 72 hours and followed up to the hospital discharge. Study has been approved by an Institutional Review Board. Binary outcomes were compared with Chi-square test and quantitative outcomes were compared with two-sample T-test. 

Results and Discussion: intubation rate was significantly lower in sedation group (n=5, 13,9%) than in control group (n-11, 35,8%), with absolute risk reduction 21,9% (p=.038), NNT=4,6. Main reasons for intubation were patient intolerance, non-resolving or progressing respiratory failure, undesired consciousness level decrease. Mean LOS in study group was 4,9±1,1 days vs. 7,3±2,4 days in control group (p<.0001). Hemodynamic instability, vomiting or aspiration and gas exchange did not varied significantly between groups. Due to small number of patients and their significant heterogeneity subgroup analysis was not performed.

Conclusion(s): our data shows that sedating uncooperative patients during NIPPV with dexmedetomidine is a reasonably safe practice that leads to improvement of NIPPV success rate and decreased ICU LOS. However, we were unable to demonstrate improvement of a specific disease outcome and further research are required.          

05 / Sedation with dexmedetomidine is safe, increasing success rate of noninvasive positive pressure ventilation in awake, uncooperative patients with acute respiratory failure