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CompletedNCT03573635SupratubeUpdated Jul 10, 2018

Continuous Supraglottic Aspiration in Intubated and Mechanically Ventilated Patients: the "SUPRAtube" Device

An interventional study of Supratube and Reference in Aspiration Pneumonias, sponsored by Fundación Cardiovascular de Colombia. Completed at 1 site in Colombia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-10.

Sponsored by Fundación Cardiovascular de Colombia · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 2 years 4 months after the study started (first participant enrolled Jan 2016, registered May 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Aspiration Pneumonias

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03

In context

Pneumonia, Aspiration

64 studies on the registry are indexed under Pneumonia, Aspiration; 12 are open to participants now.

This study's enrollment of 38 is below the median of 106 across 37 interventional studies indexed under Pneumonia, Aspiration.

Browse Pneumonia, Aspiration studies →

Lead sponsor

Fundación Cardiovascular de Colombia is the lead sponsor of 19 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Endotracheal intubation and invasive mechanical ventilation,

Exclusion criteria

Exclusion Criteria:

  • Immediate postoperative oral cavity.
  • Traumatic oral cavity injury.
  • Platelet count less than 50000.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
38 participants (actual)

Study arms

  • Other
    Supratube

    Patient with orotracheal intubation and supratube device

    Device: Supratube · Other: Reference

Interventions

  • DeviceSupratube

    Aspiration of orotracheal secretions with supratube device

  • OtherReference

    Usual aspiration with any other device

06

What researchers measure

Primary outcomes

  1. aspirated secretions

    volume of aspirated secretions

    Time frame: 24 hours after intubation

Secondary outcomes

  1. Adverse events

    Adverse events related to supratube device use

    Time frame: 24 hours after intubation

07

Study locations

1 site
  • Fundación Cardiovascular de Colombia
    Piedecuesta, Santander 681011, Colombia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03573635
Lead sponsor
Fundación Cardiovascular de Colombia
Responsible party
Sponsor
First posted
Jun 29, 2018
Start date
Jan 10, 2016
Primary completion
Dec 12, 2017
Completion
Dec 20, 2017
Last update
Jul 10, 2018

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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