Acute Lung InjuryAirconVAPNCT01150864
Effects of Airway Conditioning Devices on Ventilator Associated Pneumonia:a Randomized Clinical Trial
A study testing Airway Conditioning in people with Acute Lung Injury, run by Università degli Studi dell'Insubria at 1 site in Italy.
Trial summary
The main hypothesis are: 1. Passive and Active-Passive airway conditioning devices reduce the incidence of ventilator associated pneumonia 2. Active-Passive airway conditioning devices reduce the incidence of endotracheal tube obstruction 3. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Lung Injury
- What is being tested?
- Airway Conditioning
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2010to Mar 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients mechanically ventilated with PaO2/FiO2 lower than 300
- Age higher than 18 years
- Invasive mechanical ventilation
- Endotracheal intubation or tracheostomy for more than 24 hours
Who cannot join
- Non invasive ventilation
- Severe ARDS (PaO2/FiO2 lower than 100, or PaCO2 higher than 60 mmHg)
- Inefficient cough
- Head Trauma
- Spinal cervical trauma
- Chest trauma
Show all 11Show fewer
- Pregnancy
- Expectance of poor survival within 72 hours
- Congenital airway disease
- Immunosuppression
- Supraglottic aspiration devices
Trial locations and contacts
1 site in 1 country.
About this study
The main hypothesis are:
- Passive and Active-Passive airway conditioning devices reduce the incidence of ventilator associated pneumonia
- Active-Passive airway conditioning devices reduce the incidence of endotracheal tube obstruction
- Nurses' workload is reduced with Passive and Active-Passive airway conditioning devices
Read the detailed description
For all Three lines of the study we record Clinical Pulmonary Infection score and Airways Care Score, SOFA (Sequential Organ Failure Assessment), sedation strategy, Glasgow Coma Score and clinical data.
- Conditions
- Acute Lung Injury
- Being tested
- Airway Conditioning
- Keywords
- Hot water humidifier, Passive heat and moisture exchangers
- Medical subject headings
- Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airway ConditioningDevice
Also called Passive: Hygrobac, Active-Passive: Hygrovent Gold, Hot Water: Tyco HC 2000 heated wire
Each Passive device will be changed daily. When using Active and Passive devices as well as Active-Passive devices the ventilatory circuit will be changed every 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Passive Humidifier | Active comparator | The Passive Humidifier (HME)will changed every 24 hours Receives: Device: Airway Conditioning |
| Active-Passive humidifier | Active comparator | The Active-Passive Humidifier will be changed every 24 hours Receives: Device: Airway Conditioning |
| Hot Water Humidifier | Active comparator | Hot water humidifier will be set at 36-37 °C Receives: Device: Airway Conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of ventilator associated pneumonia
development of ventilator associated pneumonia after 48 hours of mechanical ventilation
Measured: 2 years
Secondary outcomes (2)
Endotracheal tube obstruction
difficulties to introduce the airway suction catheter and or need to change the tracheal tube
Measured: 2 years
nurses' workload
time spent at the bedside by nurses to clear airway's secretions and or to remove water condense from ventilatory circuit
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2010 (estimated)
- Study startApr 2010
- Primary completionMar 2015
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lung InjuryStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi dell'Insubria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Severgnini, Università degli Studi dell'Insubria
- Investigators
- Paolo Pelosi, MD, Study director, Universita' degli Studi dell'Insubria, Varese, ItalyPaolo Severgnini, MD, Principal investigator, University of Insubria, Varese, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01150864
- Sponsor's protocol ID
- 0001069
- Acronym
- AirconVAP
- Status last verified
- May 2017
- First submitted
- 24 May 2010
- Last updated
- 25 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Airway Conditioning Devices on Ventilator Associated Pneumonia:a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01150864
- Acronym / sponsor ID
- AirconVAP / 0001069
- Conditions
- Acute Lung Injury
- Keywords
- Hot water humidifier, Passive heat and moisture exchangers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Università degli Studi dell'InsubriaUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 25 Jun 2010 (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.
The main hypothesis are:
- Passive and Active-Passive airway conditioning devices reduce the incidence of ventilator associated pneumonia
- Active-Passive airway conditioning devices reduce the incidence of endotracheal tube obstruction
- Nurses' workload is reduced with Passive and Active-Passive airway conditioning devices
Detailed description
For all Three lines of the study we record Clinical Pulmonary Infection score and Airways Care Score, SOFA (Sequential Organ Failure Assessment), sedation strategy, Glasgow Coma Score and clinical data.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Passive Humidifier | Active comparator | Device: Airway ConditioningThe Passive Humidifier (HME)will changed every 24 hours |
| Active-Passive humidifier | Active comparator | Device: Airway ConditioningThe Active-Passive Humidifier will be changed every 24 hours |
| Hot Water Humidifier | Active comparator | Device: Airway ConditioningHot water humidifier will be set at 36-37 °C |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients mechanically ventilated with PaO2/FiO2 lower than 300
- Age higher than 18 years
- Invasive mechanical ventilation
- Endotracheal intubation or tracheostomy for more than 24 hours
Key exclusion criteria (11 listed)
- Non invasive ventilation
- Severe ARDS (PaO2/FiO2 lower than 100, or PaCO2 higher than 60 mmHg)
- Inefficient cough
- Head Trauma
- Spinal cervical trauma
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 |
|---|---|---|
| Airway ConditioningAlso: Passive: Hygrobac, Active-Passive: Hygrovent Gold, Hot Water: Tyco HC 2000 heated wireEach Passive device will be changed daily. When using Active and Passive devices as well as Active-Passive devices the ventilatory circuit will be changed every 7 days. | Device | Active-Passive humidifier, Hot Water Humidifier, Passive Humidifier |
Primary outcome
Reduction of ventilator associated pneumonia
Time frame: 2 years
development of ventilator associated pneumonia after 48 hours of mechanical ventilation
2 secondary outcomes
Endotracheal tube obstruction
Time frame: 2 years
nurses' workload
Time frame: 2 years
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 25 May 2017.
Related trials for Acute Lung Injury
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Not yet recruitingObservational study
Development and Multicenter Validation of an Explainable System for Neonatal ARDS-Compatible Phenotyping
Acute Respiratory Distress Syndrome
RecruitingObservational study
Assessment of Blood Viscosity in ARDS (Acute Respiratory Distress Syndrome)
ARDS
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
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.
Paolo Pelosi, MD study director
Universita' degli Studi dell'Insubria, Varese, Italy
Paolo Severgnini, MD principal investigator
University of Insubria, Varese, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Airway Conditioning in people with Acute Lung Injury, run by Università degli Studi dell'Insubria at 1 site in Italy.
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 4 inclusion and 11 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 25 May 2017. 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 Italy. 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?
Reduction of ventilator associated pneumonia (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 May 2017.