LipoAerosol© Inhalation After Tracheostomy

Study Overview
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Brief Summary
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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.

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

Conditions
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Other Tracheostomy Complication

Intervention / Treatment
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* Device: LipoAerosol© inhalation
* Other: Physiologic saline inhalation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≤24h after tracheostomy and regular patient's consent Exclusion Criteria: No regular patient's consent Known allergy for ingredients Patients >24h after tracheostomy Patients with acute or imminent sepsis Patients with existing bronchopulmonary inflammation Patients with immunosuppressive therapy Patients with poorly adjusted pulmonary disease Patients with chronic respiratory insufficiency
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LipoAerosol©<br>LipoAerosol© inhalation, 5x/d for 30min | Device: LipoAerosol© inhalation<br>* LipoAerosol© inhalation, 5x/d for 30min<br>|
| Other: Physiologic saline inhalation<br>Physiologic saline inhalation, 5x/d for 30min | Other: Physiologic saline inhalation<br>* Physiologic saline inhalation, 5x/d for 30min<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in tracheal interleukin 6 levels | Tracheal secretion: Interleukin 6 | at day 10 after tracheostomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the number of suction maneuver, tracheo-bronchial redness, and mucous congestion | Changes in the respiratory impairment due to the medical estimation at day 10. The medical estimation includes 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). | at day 10 after tracheostomy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tracheostomy, inflammation, mucous congestion, inhalation therapy, phospholipids