LipoAerosol©-Inhalation for the maintenance of the functional integrity of the tracheobronchial system after tracheostomy

Introduction:

After tracheostomy patients demonstrate shunt ventilation bypassing the sinonasal and pharyngeal system. The physiological moistening, cleaning and warming of the breathing air fail resulting in respiratory inflammation. Beside a variety of supportive medical devices, no general recommendation exists at present. Aim of the study is to maintain the functional integrity of the tracheobronchial system after tracheostomy resulting in a general therapeutic recommendation.

Methods:

In this two-armed, double-blinded, randomized parallel group study the application of local phospholipids (LipoAerosol©) compared with standard physiologic saline inhalation should be evaluated (NCT02157129). Blood and tracheobronchial secretion parameter were collected 1, 3 and 10 days after tracheostomy (primary endpoint). Frequency of suction maneuver and the assessment of the tracheobronchial redness and mucous congestion was documented (secondary endpoint).

Results:

Fifty patients were randomized in the experimental arm (LipoAerosol©) and 50 patients in the placebo arm (physiologic saline solution). No differences between the two arms regarding demographic and clinical data were observed. The secondary endpoint could be reached since the evaluated parameter improved significantly in the experimental arm compared to the placebo arm (p = 0.04). The IL-6 level in the tracheobronchial secretion decreased significantly clearer in the experimental than in the placebo arm (p = 0.02).

Conclusions:

The liposomal inhalation resulted in the maintenance of the functional integrity of the tracheobronchial system which could be shown by the reduction of IL-6 in the tracheobronchial secretion and the improvement of various clinical parameter in the experimental arm compared to the placebo arm.

Publication History

Publication Date:
18 April 2018 (online)