LipoAerosol© Inhalation After Tracheostomy

NCT02157129 | Completed DMC

• 1 other identifier: HNO-TUM-LT1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Other Tracheostomy Complication

Keywords

Tracheostomy; inflammation; mucous congestion; inhalation therapy; phospholipids

Outcome Measures

Primary Outcomes (1)

• Changes in tracheal interleukin 6 levels

  Tracheal secretion: Interleukin 6

  at day 10 after tracheostomy

Secondary Outcomes (1)

• Changes in the number of suction maneuver, tracheo-bronchial redness, and mucous congestion

  at day 10 after tracheostomy

Other Outcomes (2)

• Changes in the inflammatory blood and tracheal secretion parameters

  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

  at day 1, 3, 10 after tracheostomy

Study Arms (2)

LipoAerosol©

EXPERIMENTAL

LipoAerosol© inhalation, 5x/d for 30min

Device: LipoAerosol© inhalation

Physiologic saline inhalation

OTHER

Physiologic saline inhalation, 5x/d for 30min

Other: Physiologic saline inhalation

Interventions

LipoAerosol© inhalation DEVICE

LipoAerosol© inhalation, 5x/d for 30min

LipoAerosol©

Physiologic saline inhalation OTHER

Physiologic saline inhalation, 5x/d for 30min

Physiologic saline inhalation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≤24h after tracheostomy and regular patient's consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

HNO, Klinikum rechts der Isar, Technische Universität München

Munich, Bavaria, 81675, Germany

Location

Related 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. doi: 10.1152/japplphysiol.00523.2004. Epub 2004 Aug 13.

  PMID: 15310745 BACKGROUND

• 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.

  PMID: 24777579 BACKGROUND

• 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.

  PMID: 23868654 BACKGROUND

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andreas Knopf, PD Dr.

  HNO, Klinikum rechts der Isar, TU München

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2014
• First Posted: June 5, 2014
• Study Start: May 1, 2014
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: July 6, 2022

Record last verified: 2017-08

Locations

DE (1)