Endotracheal TubeNCT01547507
Performance Evaluation of AirWay Medix Closed Suction System Compared With a Standard Closed Suction System
A study testing AirWay Medix Closed Suction System in people with Endotracheal Tube and Mechanical Ventilation, run by Biovo Technologies Ltd at 1 site in Israel.
Trial summary
The aim of this prospective, randomized study is to compare the performance, safety, and ease of use (usability) between two closed suction systems, the AirWay Medix Closed Suction System and Kimberly KimVent while intubated with an endotracheal in hospitals and ICU. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Endotracheal Tube, Mechanical Ventilation
- What is being tested?
- AirWay Medix Closed Suction System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2012to Dec 2012
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged greater than 18 years
- Mechanically ventilated for more than 6 hours
- Endotracheal intubation anticipated to be routine (not difficult) based upon preoperative airway assessment
- Signed informed consent
- Sexually active female subjects of childbearing potential must be practicing adequate contraception during the treatment period -
Who cannot join
- Gross / massive hemoptysis
- Received lung transplantation in the past
- Admitted from other hospital already mechanically ventilated
- Previously received mechanical ventilation
- Active bronchial bleeding
- Pregnant women, women who plan to become pregnant and breastfeeding women.
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- Substance or alcohol abuse
- Participation in concurrent trials
- Any reasons making the patient a poor candidate in the opinion of the investigator -
Trial locations and contacts
1 site in 1 country.
Nimrod Adi, MD contact
About this study
The aim of this prospective, randomized study is to compare the performance, safety, and ease of use (usability) between two closed suction systems, the AirWay Medix Closed Suction System and Kimberly KimVent while intubated with an endotracheal in hospitals and ICU. 26 adults with an endotracheal tube and mechanical ventilation will be randomized into 2 groups to receive one of the following closed suction systems endotracheal tubes:
- AirWay Medix Closed Suction System
- KimVent Turbo-Cleaning Closed Suction System Kimberly clarK The groups will be compared regarding the safety, performance and ease of use (usability).
- Conditions
- Endotracheal Tube, Mechanical Ventilation
- Being tested
- AirWay Medix Closed Suction System
- Keywords
- hemodynamics, respiratory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AirWay Medix Closed Suction SystemDevice
AirWay Medix Closed Suction System
| Study group | Role | What they receive |
|---|---|---|
| KimVent Turbo-Cleaning Closed Suction System Kimberly clark | Active comparator | Not described Receives: Device: AirWay Medix Closed Suction System |
| Airway Medix Closed Suction System | Active comparator | Not described Receives: Device: AirWay Medix Closed Suction System |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemodynamic and respiratory data
Measured: Patients will be followed until extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endotracheal TubeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biovo Technologies Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nimrod Adi, MD, Principal investigator, Kaplan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01547507
- Sponsor's protocol ID
- Biovo-12-CTIL
- Status last verified
- May 2012
- First submitted
- 22 Feb 2012
- Last updated
- 30 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Evaluation of AirWay Medix Closed Suction System Compared With a Standard Closed Suction System
- ClinicalTrials.gov ID
- NCT01547507
- Acronym / sponsor ID
- Biovo-12-CTIL
- Conditions
- Endotracheal Tube, Mechanical Ventilation
- Keywords
- hemodynamics, respiratory
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Biovo Technologies LtdIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Dec 2012 (estimated)
- First posted
- 8 Mar 2012 (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 aim of this prospective, randomized study is to compare the performance, safety, and ease of use (usability) between two closed suction systems, the AirWay Medix Closed Suction System and Kimberly KimVent while intubated with an endotracheal in hospitals and ICU. 26 adults with an endotracheal tube and mechanical ventilation will be randomized into 2 groups to receive one of the following closed suction systems endotracheal tubes:
- AirWay Medix Closed Suction System
- KimVent Turbo-Cleaning Closed Suction System Kimberly clarK The groups will be compared regarding the safety, performance and ease of use (usability).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KimVent Turbo-Cleaning Closed Suction System Kimberly clark | Active comparator | Device: AirWay Medix Closed Suction System |
| Airway Medix Closed Suction System | Active comparator | Device: AirWay Medix Closed Suction System |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged greater than 18 years
- Mechanically ventilated for more than 6 hours
- Endotracheal intubation anticipated to be routine (not difficult) based upon preoperative airway assessment
- Signed informed consent
- Sexually active female subjects of childbearing potential must be practicing adequate contraception during the treatment period -
Key exclusion criteria (9 listed)
- Gross / massive hemoptysis
- Received lung transplantation in the past
- Admitted from other hospital already mechanically ventilated
- Previously received mechanical ventilation
- Active bronchial bleeding
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 Medix Closed Suction SystemAirWay Medix Closed Suction System | Device | Airway Medix Closed Suction System, KimVent Turbo-Cleaning Closed Suction System Kimberly clark |
Primary outcome
hemodynamic and respiratory data
Time frame: Patients will be followed until extubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2012.
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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.
Nimrod Adi, MD contact
Nimrod Adi, MD principal investigator
Kaplan Medical Center
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 Medix Closed Suction System in people with Endotracheal Tube and Mechanical Ventilation, run by Biovo Technologies Ltd at 1 site in Israel.
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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 30 May 2012. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nimrod Adi, MD (Nimrodad@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hemodynamic and respiratory data (time frame: Patients will be followed until extubation). 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 30 May 2012.