LipoAerosol© Inhalation After Tracheostomy

Not Applicable

Completed

• Conditions: Other Tracheostomy Complication
• Interventions: Device: LipoAerosol© inhalation; Other: Physiologic saline inhalation

• Registration Number: NCT02157129
• Lead Sponsor: Technical University of Munich

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-27
• Study First Submitted QC: 2014-06-03
• Study First Posted: 2014-06-05
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Status Verified: 2017-08
• Last Update Submitted: 2022-07-01
• Last Update Posted: 2022-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LipoAerosol©	LipoAerosol© inhalation	LipoAerosol© inhalation, 5x/d for 30min
Physiologic saline inhalation	Physiologic saline inhalation	Physiologic saline inhalation, 5x/d for 30min

Primary Outcome Measures

Name	Time	Method
Changes in tracheal interleukin 6 levels	at day 10 after tracheostomy	Tracheal secretion: Interleukin 6

Secondary Outcome Measures

Name	Time	Method
Changes in the number of suction maneuver, tracheo-bronchial redness, and mucous congestion	at day 10 after tracheostomy	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).

Trial Locations

Locations (1)

HNO, Klinikum rechts der Isar, Technische Universität München; 🇩🇪 Munich, Bavaria, Germany