LipoAerosol© Inhalation After Tracheostomy

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

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.

Study Overview

• Status: Completed
• Conditions: Other Tracheostomy Complication
• Intervention / Treatment: Device: LipoAerosol© inhalation; Other: Physiologic saline inhalation

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 81675
      • HNO, Klinikum rechts der Isar, Technische Universität München

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LipoAerosol©; LipoAerosol© inhalation, 5x/d for 30min	Device: LipoAerosol© inhalation; LipoAerosol© inhalation, 5x/d for 30min
Other: Physiologic saline inhalation; Physiologic saline inhalation, 5x/d for 30min	Other: Physiologic saline inhalation; Physiologic saline inhalation, 5x/d for 30min

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 γ, interleukins 10, 12 (p70), 13, 1β, 2, 4, 5, 6, 7, 8, tumor necrosis factor α	at day 1, 3, 10 after tracheostomy
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

Collaborators and Investigators

• Sponsor: Technical University of Munich
• Investigators: Principal Investigator: Andreas Knopf, PD Dr., HNO, Klinikum rechts der Isar, TU München

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: May 27, 2014
• First Submitted That Met QC Criteria: June 3, 2014
• First Posted (Estimate): June 5, 2014

Study Record Updates

• Last Update Posted (Actual): July 6, 2022
• Last Update Submitted That Met QC Criteria: July 1, 2022
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: inflammation; Tracheostomy; inhalation therapy; mucous congestion; phospholipids
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: HNO-TUM-LT1