Clinical trial NCT02157129: LipoAerosol© Inhalation After Tracheostomy
Official title: LipoAerosol© Inhalation to Maintain the Functional Integrity of the Tracheo-bronchial System in Patients After Tracheostomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Other Tracheostomy Complication
Keywords: Tracheostomy
inflammation
mucous congestion
inhalation therapy
phospholipids
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2014-06-05
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in tracheal interleukin 6 levels
timeFrame: at day 10 after tracheostomy
Secondary outcomes:
measure: Changes in the number of suction maneuver, tracheo-bronchial redness, and mucous congestion
timeFrame: at day 10 after tracheostomy
Other outcomes:
measure: Changes in the inflammatory blood and tracheal secretion parameters
timeFrame: at day 1, 3, 10 after tracheostomy
measure: Changes in the subjective overall impairment, coughing frequency, breathlessness, mucous congestion, color of sputum, consistency of sputum on the visual analogue scale
timeFrame: at day 1, 3, 10 after tracheostomy
Locations:
city: Munich
country: Germany
facility: HNO, Klinikum rechts der Isar, Technische Universität München
state: Bavaria
Study officials:
affiliation: HNO, Klinikum rechts der Isar, TU München
name: Andreas Knopf, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Braun A, Steinecker M, Schumacher S, Griese M. Surfactant function in children with chronic airway inflammation. J Appl Physiol (1985). 2004 Dec;97(6):2160-5. doi: 10.1152/japplphysiol.00523.2004. Epub 2004 Aug 13.
citation: Hofauer B, Bas M, Strassen U, Matsuba Y, Mansour N, Knopf A. [Liposomal local therapy of sinunasal symptoms in ANCA associated vasculitis]. Laryngorhinootologie. 2014 Jul;93(7):461-6. doi: 10.1055/s-0034-1372588. Epub 2014 Apr 28. German.
citation: Hofauer B, Bas M, Manour N, Knopf A. [Liposomal local therapy as treatment for sicca symptoms in patients with primary Sjogren's syndrome]. HNO. 2013 Nov;61(11):921-7. doi: 10.1007/s00106-013-2736-x. German.