Intensive Critical UnitSUPRANAVNCT03573609
Evaluation of the Effectiveness and Safety of Supratube Device
A study testing Supranav in people with Intensive Critical Unit and Pneumonia, run by Fundación Cardiovascular de Colombia at 1 site in Colombia.
Trial summary
Purpose of the trial: Trial design: Two-parallel arm, double-blind, individually randomized controlled trial. Primary endpoint: Clinical evaluation of sinus, oropharyngeal, tracheal, bronchial or pulmonary infections during orotracheal intubation and hospital admission. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Critical Unit, Pneumonia, Aspiration
- What is being tested?
- Supranav
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteColombia
- Study dates
- 29 May 2018to 20 Jan 2020
- 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
- Intubated adult patients with mechanical ventilation.
- To have a closest responsible relative
- Integrity of the airways
Who cannot join
- Need of orofacial, cervical or respiratory tract surgical procedures
- Patients with tracheostomy
- Shock,
- Local or systemic uncontrolled infection
- Blood dyscrasia, neoplastic diseases
- Physiological alteration
- Acute or chronic decompensated pathology that is not controlled at the time of selection.
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Fundación Cardiovascular de Colombia
Piedecuesta, Santander Department, 681011
About this study
Official title: Multicenter, Controlled, Randomized Clinical Trial to Evaluate the Effectiveness and Safety of the New Supratube Invention Device to Prevent Pneumonia Associated With Mechanical Ventilation: " Supra-nav Project "
Purpose of the trial:
Trial design: Two-parallel arm, double-blind, individually randomized controlled trial.
Read more
Primary endpoint:
Clinical evaluation of sinus, oropharyngeal, tracheal, bronchial or pulmonary infections during orotracheal intubation and hospital admission.
Secondary endpoints:
Volume of oropharyngeal secretions aspirated per unit of time (for 24 hours) by the SupraTube and Complications during the use of the SupraTube device: erosions, lacerations, Bleeding, displacement, migration, need for withdrawal.
Inclusion criteria:
- Adult patient
- Orotracheal intubation ≤ 72 hours
- Hospitalized in ICU
- integrity of upper airways
Exclusion criteria:
- International patients
- Coagulopathic patients
- oncology patients
- patients with maxillofacial surgery
- Absence of close responsible family member
- Tracheostomy, shock, local or systemic non-controlled infection
Trial treatment:
Intervention:
Aspiration of secretions with the supranav device
Control:
Usual respiratory care
Expected sample size, enrollment and expected number of centers:
Sample size = 108
Recruitment start date:
Recruitment end date:
Follow-up end date:
Number of centers: 2
Statistical considerations:
- Intention to treat analysis
- The primary outcomes will be analyzed using
- Conditions
- Intensive Critical Unit, Pneumonia, Aspiration, Prevention and Control
- Being tested
- Supranav
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SupranavDevice
Continuous supraglottic suction device for patients with orotraqueal intubation an mechanical ventilation
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Usual respiratory care |
| Supranav | Active comparator | Respiratory care with "supranav" which is a continuous supraglottic suction device Receives: Device: Supranav |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator associated events
A group of all the conditions that result in a significant and sustained deterioration in oxygenation, defined as a greater than 20% increase in the daily minimum fraction of inspired oxygen or an increase of at least 3 cm H2O in the daily minimum positive end-expiratory pressure (PEEP) to maintain oxygenation. It is imperative to understand that both infectious conditions (such as tracheitis, tracheobronchitis, and pneumonia) and noninfectious conditions (such as atelectasis, pulmonary embolism, pulmonary edema, ventilator-induced lung injury, and others) may fulfill this VAE definition.
Measured: 24 hours after extubation
Secondary outcomes (1)
Adverse events
Number of patientes with Bleeding and lacerations in the oropharynx
Measured: 24 hours after extubation
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 start29 May 2018
- Primary completion1 Dec 2019
- Study completion20 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intensive Critical UnitStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Cardiovascular de Colombia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alba L Ramirez Sarmiento, PhD, Principal investigator, Fundación Cardiovascular de Colombia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03573609
- Sponsor's protocol ID
- 0001
- Acronym
- SUPRANAV
- Status last verified
- Apr 2018
- First submitted
- 10 May 2018
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Orozco-Levi M, Tiga-Loza DC, Aya O, Reyes CF, Caceres-Rivera D, Espitia A, Rey D, Pedrozo Arias KP, Pizarro C, Sanabria-Barrera SM, Serrano-Diaz N, Castillo VR, Ramirez-Sarmiento A. A Novel Supraglottic Suction Device in Mechanically Ventilated Patients: A Randomized Controlled Trial. Med Devices (Auckl). 2025 Mar 24;18:201-212. doi: 10.2147/MDER.S499924. eCollection 2025.
PubMed 40161252
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Controlled, Randomized Clinical Trial to Evaluate the Effectiveness and Safety of the New Supratube Invention Device to Prevent Pneumonia Associated With Mechanical Ventilation: " Supra-nav Project "
- ClinicalTrials.gov ID
- NCT03573609
- Acronym / sponsor ID
- SUPRANAV / 0001
- Conditions
- Intensive Critical Unit, Pneumonia, Aspiration, Prevention and Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Fundación Cardiovascular de ColombiaUniversity, hospital or other
- Study start
- 29 May 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 20 Jan 2020 (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:
Trial design: Two-parallel arm, double-blind, individually randomized controlled trial.
Primary endpoint:
Clinical evaluation of sinus, oropharyngeal, tracheal, bronchial or pulmonary infections during orotracheal intubation and hospital admission.
Secondary endpoints:
Volume of oropharyngeal secretions aspirated per unit of time (for 24 hours) by the SupraTube and Complications during the use of the SupraTube device: erosions, lacerations, Bleeding, displacement, migration, need for withdrawal.
Inclusion criteria:
- Adult patient
- Orotracheal intubation ≤ 72 hours
- Hospitalized in ICU
- integrity of upper airways
Exclusion criteria:
- International patients
- Coagulopathic patients
- oncology patients
- patients with maxillofacial surgery
- Absence of close responsible family member
- Tracheostomy, shock, local or systemic non-controlled infection
Trial treatment:
Intervention:
Aspiration of secretions with the supranav device
Control:
Usual respiratory care
Expected sample size, enrollment and expected number of centers:
Sample size = 108
Recruitment start date:
Recruitment end date:
Follow-up end date:
Number of centers: 2
Statistical considerations:
- Intention to treat analysis
- The primary outcomes will be analyzed using
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Usual respiratory care |
| Supranav | Active comparator | Device: SupranavRespiratory care with "supranav" which is a continuous supraglottic suction device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Intubated adult patients with mechanical ventilation.
- To have a closest responsible relative
- Integrity of the airways
Key exclusion criteria (7 listed)
- Need of orofacial, cervical or respiratory tract surgical procedures
- Patients with tracheostomy
- Shock,
- Local or systemic uncontrolled infection
- Blood dyscrasia, neoplastic diseases
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 |
|---|---|---|
| SupranavContinuous supraglottic suction device for patients with orotraqueal intubation an mechanical ventilation | Device | Supranav |
Primary outcome
Ventilator associated events
Time frame: 24 hours after extubation
A group of all the conditions that result in a significant and sustained deterioration in oxygenation, defined as a greater than 20% increase in the daily minimum fraction of inspired oxygen or an increase of at least 3 cm H2O in the daily minimum positive end-expiratory pressure (PEEP) to maintain oxygenation. It is imperative to understand that both infectious conditions (such as tracheitis, tracheobronchitis, and pneumonia) and noninfectious conditions (such as atelectasis, pulmonary embolism, pulmonary edema, ventilator-induced lung injury, and others) may fulfill this VAE definition.
1 secondary outcome
Adverse events
Time frame: 24 hours after extubation
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 20 Apr 2022.
- Derived from this study: PubMed 40161252Orozco-Levi M, Tiga-Loza DC, Aya O, Reyes CF, Caceres-Rivera D, Espitia A, Rey D, Pedrozo Arias KP, Pizarro C, Sanabria-Barrera SM, Serrano-Diaz N, Castillo VR, Ramirez-Sarmiento A. A Novel Supraglottic Suction Device in Mechanically Ventilated Patients: A Randomized Controlled Trial. Med Devices (Auckl). 2025 Mar 24;18:201-212. doi: 10.2147/MDER.S499924. eCollection 2025.
- Individual participant dataSharing planned: Undecided
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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.
Alba L Ramirez Sarmiento, PhD principal investigator
Fundación Cardiovascular de Colombia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supranav in people with Intensive Critical Unit and Pneumonia, 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 3 inclusion and 7 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 20 Apr 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 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?
Ventilator associated events (time frame: 24 hours after extubation). 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 NCT03573609, which also lists 1 linked publication.
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 20 Apr 2022.