LipoAerosol© Inhalation After Tracheostomy

Other Tracheostomy Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02157129
• Other study ID #: HNO-TUM-LT1
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: April 2017

Study information

• Verified date: August 2017
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Other Tracheostomy Complication
• Respiratory Aspiration

Intervention

Device:
• LipoAerosol© inhalation
LipoAerosol© inhalation, 5x/d for 30min

Other:
• Physiologic saline inhalation
Physiologic saline inhalation, 5x/d for 30min

Locations

Country	Name	City	State
Germany	HNO, Klinikum rechts der Isar, Technische Universität München	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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. Epub 2004 Aug 13. — View Citation

Hofauer B, Bas M, Manour N, Knopf A. [Liposomal local therapy as treatment for sicca symptoms in patients with primary Sjögren's syndrome]. HNO. 2013 Nov;61(11):921-7. doi: 10.1007/s00106-013-2736-x. German. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in the inflammatory blood and tracheal secretion parameters	Blood: C reactive protein, leucocytes Tracheal secretion: Lymphocyte subpopulation, c reactive protein, lactate dehydrogenase, granulocyte macrophage colony stimulating factor, interferon ?, interleukins 10, 12 (p70), 13, 1ß, 2, 4, 5, 6, 7, 8, tumor necrosis factor a	at day 1, 3, 10 after tracheostomy
Other	Changes in the subjective overall impairment, coughing frequency, breathlessness, mucous congestion, color of sputum, consistency of sputum on the visual analogue scale	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).	at day 1, 3, 10 after tracheostomy
Primary	Changes in tracheal interleukin 6 levels	Tracheal secretion: Interleukin 6	at day 10 after tracheostomy
Secondary	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