NCT02157129

LipoAerosol© Inhalation After Tracheostomy

LipoAerosol© Inhalation to Maintain the Functional Integrity of the Tracheo-bronchial System in Patients After Tracheostomy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Technical University of Munich · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Patients after tracheostomy represent a substantial part in the ear nose throat clinic. Long-term intubated patients in intensive care units also profit from tracheostomy due to an improved respiratory toilet. However, 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 a respiratory inflammation. Beside a variety of supportive medical devices no general recommendation exists at present. Recently, we demonstrated the beneficial application of local phospholipids in Sjoegren's syndrome and antineutrophil cytoplasmatic antibody associated sinonasal vasculitis. In the current monocentric, two-armed, double-blinded, randomized parallel group study we would like to evaluate the beneficial application of LipoAerosol© when compared with standard physiologic saline inhalation. LipoAerosol© is a licensed, tradable medical device and will be applied as part of its intended use. Liposomal inhalation solution provides moistening, cleaning and warming of the upper and lower respiratory tract and supports the natural moistening film in airway irritations and diseases. Blood parameter (leucocytes and c reactive protein) and tracheobronchial secretion (Lymphocyte subpopulation, c reactive protein, lactate dehydrogenase, granulocyte macrophage colony stimulating factor, interferon γ, interleukins 10, 12 (p70), 13, 1β, 2, 4, 5, 6, 7, 8, tumor necrosis factor α) will be collected 1, 3, and 10 days after tracheostomy. In addition, medical examination records the number of suction maneuver (0 points: none; 1 point: 5-10x/d; 2 points: 10-20x/d; 3 points: \>20x/d), flexible-optical assessment of tracheo-bronchial redness (0 point: none; 1 point: peristomal; 2 points: tracheal; 3 points: tracheo-bronchial) and flexible-optical assessment of mucous congestion (0 point: none; 1 point: fluent; 2 points: tenacious; 3 points: barky). Subjective estimation of the respiratory impairment will be analyzed via visual analogue scale (Subjective overall impairment, coughing frequency, breathlessness, mucous congestion, color of sputum, consistency of sputum). The study is designed without any additional invasive or incriminating clinical examination. Aim of the study is to maintain the functional integrity of the tracheo-bronchial system after tracheostomy using LipoAerosol© resulting in a general therapeutic recommendation.

Conditions

• Other Tracheostomy Complication

Interventions

Type	Name	Description
DEVICE	LipoAerosol© inhalation	LipoAerosol© inhalation, 5x/d for 30min
OTHER	Physiologic saline inhalation	Physiologic saline inhalation, 5x/d for 30min

Timeline

• Start date: 2014-05-01
• Primary completion: 2017-04-01
• Completion: 2017-04-01
• First posted: 2014-06-05
• Last updated: 2022-07-06

Locations

1 site across 1 country: Germany