Aspiration PneumoniasSupratubeNCT03573635
Continuous Supraglottic Aspiration in Intubated and Mechanically Ventilated Patients: the "SUPRAtube" Device
A study testing Supratube and Reference in people with Aspiration Pneumonias, run by Fundación Cardiovascular de Colombia at 1 site in Colombia.
Trial summary
Purpose of the trial: Evaluate the efficacy and safety of the device of self-invention of continuous oropharyngeal aspiration denominated "SUPRAtube" in patients with orotracheal intubation and mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aspiration Pneumonias
- What is being tested?
- Supratube and Reference
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteColombia
- Study dates
- 10 Jan 2016to 20 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Endotracheal intubation and invasive mechanical ventilation,
Who cannot join
- Immediate postoperative oral cavity.
- Traumatic oral cavity injury.
- Platelet count less than 50000.
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Fundación Cardiovascular de Colombia
Piedecuesta, Santander Department, 681011
About this study
Official title: Evaluation of the Effectiveness and Safety of an Own-invention System for Continuous Supraglottic Aspiration in Intubated and Mechanically Ventilated Patients: the "SUPRAtube" Device
Purpose of the trial: Evaluate the efficacy and safety of the device of self-invention of continuous oropharyngeal aspiration denominated "SUPRAtube" in patients with orotracheal intubation and mechanical ventilation.
- Conditions
- Aspiration Pneumonias
- Being tested
- Supratube, Reference
- Medical subject headings
- Pneumonia, Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SupratubeDevice
Aspiration of orotracheal secretions with supratube device
ReferenceOther
Usual aspiration with any other device
| Study group | Role | What they receive |
|---|---|---|
| Supratube | Other | Patient with orotracheal intubation and supratube device Receives: Device: Supratube; Other: Reference |
What is being measured
The primary outcome is the main question the study is designed to answer.
aspirated secretions
volume of aspirated secretions
Measured: 24 hours after intubation
Secondary outcomes (1)
Adverse events
Adverse events related to supratube device use
Measured: 24 hours after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2018
- Study start10 Jan 2016
- Primary completion12 Dec 2017
- Study completion20 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aspiration PneumoniasStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Cardiovascular de Colombia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03573635
- Sponsor's protocol ID
- 004
- Acronym
- Supratube
- Status last verified
- Jul 2018
- First submitted
- 31 May 2018
- Last updated
- 10 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness and Safety of an Own-invention System for Continuous Supraglottic Aspiration in Intubated and Mechanically Ventilated Patients: the "SUPRAtube" Device
- ClinicalTrials.gov ID
- NCT03573635
- Acronym / sponsor ID
- Supratube / 004
- Conditions
- Aspiration Pneumonias
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Fundación Cardiovascular de ColombiaUniversity, hospital or other
- Study start
- 10 Jan 2016 (actual)
- Primary completion
- 12 Dec 2017 (actual)
- Study completion
- 20 Dec 2017 (actual)
- First posted
- 29 Jun 2018 (actual)
- 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.
Purpose of the trial: Evaluate the efficacy and safety of the device of self-invention of continuous oropharyngeal aspiration denominated "SUPRAtube" in patients with orotracheal intubation and mechanical ventilation.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supratube | Other | Device: Supratube, Other: ReferencePatient with orotracheal intubation and supratube device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Endotracheal intubation and invasive mechanical ventilation,
Key exclusion criteria (3 listed)
- Immediate postoperative oral cavity.
- Traumatic oral cavity injury.
- Platelet count less than 50000.
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 |
|---|---|---|
| SupratubeAspiration of orotracheal secretions with supratube device | Device | Supratube |
| ReferenceUsual aspiration with any other device | Other | Supratube |
Primary outcome
aspirated secretions
Time frame: 24 hours after intubation
volume of aspirated secretions
1 secondary outcome
Adverse events
Time frame: 24 hours after intubation
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 10 Jul 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supratube and Reference in people with Aspiration Pneumonias, run by Fundación Cardiovascular de Colombia at 1 site in Colombia.
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 3 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 10 Jul 2018. 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 Colombia. 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?
aspirated secretions (time frame: 24 hours after intubation). 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 10 Jul 2018.