NCT03573635CompletedNot Applicable
Evaluation of the Effectiveness and Safety of an Own-invention System for Continuous Supraglottic Aspiration in Intubated and Mechanically Ventilated Patients: the "SUPRAtube" Device
Fundación Cardiovascular de Colombia2 sites in 1 country38 target enrollmentStarted: January 10, 2016Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 38
- Locations
- 2
- Primary Endpoint
- aspirated secretions
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Endotracheal intubation and invasive mechanical ventilation,
Exclusion Criteria
- •Immediate postoperative oral cavity.
- •Traumatic oral cavity injury.
- •Platelet count less than 50000.
Arms & Interventions
Supratube
Other
Patient with orotracheal intubation and supratube device
Intervention: Supratube (Device)
Supratube
Other
Patient with orotracheal intubation and supratube device
Intervention: Reference (Other)
Outcomes
Primary Outcomes
aspirated secretions
Time Frame: 24 hours after intubation
volume of aspirated secretions
Secondary Outcomes
- Adverse events(24 hours after intubation)
Investigators
Study Sites (2)
Loading locations...
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