Other Tracheostomy ComplicationNCT02157129
LipoAerosol© Inhalation After Tracheostomy
A study testing LipoAerosol© inhalation and Physiologic saline inhalation in people with Other Tracheostomy Complication, run by Technical University of Munich at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Other Tracheostomy Complication
- What is being tested?
- LipoAerosol© inhalation and Physiologic saline inhalation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- May 2014to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients ≤24h after tracheostomy and regular patient's consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
HNO, Klinikum rechts der Isar, Technische Universität München
Munich, Bavaria, 81675
About this study
Official title: 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.
Read more
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
- Being tested
- LipoAerosol© inhalation, Physiologic saline inhalation
- Keywords
- Tracheostomy, inflammation, mucous congestion, inhalation therapy, phospholipids
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LipoAerosol© inhalationDevice
LipoAerosol© inhalation, 5x/d for 30min
Physiologic saline inhalationOther
Physiologic saline inhalation, 5x/d for 30min
| Study group | Role | What they receive |
|---|---|---|
| LipoAerosol© | Experimental | LipoAerosol© inhalation, 5x/d for 30min Receives: Device: LipoAerosol© inhalation |
| Physiologic saline inhalation | Other | Physiologic saline inhalation, 5x/d for 30min Receives: Other: Physiologic saline inhalation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in tracheal interleukin 6 levels
Tracheal secretion: Interleukin 6
Measured: at day 10 after tracheostomy
Secondary outcomes (1)
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).
Measured: at day 10 after tracheostomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Other Tracheostomy ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas Knopf, PD Dr., Principal investigator, HNO, Klinikum rechts der Isar, TU München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02157129
- Sponsor's protocol ID
- HNO-TUM-LT1
- Status last verified
- Aug 2017
- First submitted
- 27 May 2014
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 15310745Hofauer 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.
PubMed 24777579Hofauer 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.
PubMed 23868654
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LipoAerosol© Inhalation to Maintain the Functional Integrity of the Tracheo-bronchial System in Patients After Tracheostomy
- ClinicalTrials.gov ID
- NCT02157129
- Acronym / sponsor ID
- HNO-TUM-LT1
- Conditions
- Other Tracheostomy Complication
- Keywords
- Tracheostomy, inflammation, mucous congestion, inhalation therapy, phospholipids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 5 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LipoAerosol© | Experimental | Device: LipoAerosol© inhalationLipoAerosol© inhalation, 5x/d for 30min |
| Physiologic saline inhalation | Other | Other: Physiologic saline inhalationPhysiologic saline inhalation, 5x/d for 30min |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients ≤24h after tracheostomy and regular patient's consent
Key exclusion criteria (8 listed)
- No regular patient's consent
- Known allergy for ingredients
- Patients >24h after tracheostomy
- Patients with acute or imminent sepsis
- Patients with existing bronchopulmonary inflammation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LipoAerosol© inhalationLipoAerosol© inhalation, 5x/d for 30min | Device | LipoAerosol© |
| Physiologic saline inhalationPhysiologic saline inhalation, 5x/d for 30min | Other | Physiologic saline inhalation |
Primary outcome
Changes in tracheal interleukin 6 levels
Time frame: at day 10 after tracheostomy
Tracheal secretion: Interleukin 6
1 secondary outcome
Changes in the number of suction maneuver, tracheo-bronchial redness, and mucous congestion
Time frame: at day 10 after tracheostomy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
- Background: PubMed 15310745Braun 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.
- Background: PubMed 24777579Hofauer 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.
- Background: PubMed 23868654Hofauer 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Knopf, PD Dr. principal investigator
HNO, Klinikum rechts der Isar, TU München
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LipoAerosol© inhalation and Physiologic saline inhalation in people with Other Tracheostomy Complication, run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in tracheal interleukin 6 levels (time frame: at day 10 after tracheostomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02157129, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2022.