Back to resultsContinuous Supraglottic Aspiration in Intubated and Mechanically Ventilated Patients: the "SUPRAtube" Device (Supratube)
Primary Purpose
Aspiration Pneumonias
Status
Completed
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
Supratube
Reference
Sponsored by
About this trial
This is an interventional other trial for Aspiration Pneumonias
Eligibility Criteria
Inclusion Criteria:
• Endotracheal intubation and invasive mechanical ventilation,
Exclusion Criteria:
- Immediate postoperative oral cavity.
- Traumatic oral cavity injury.
- Platelet count less than 50000.
Sites / Locations
- Fundación Cardiovascular de Colombia
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Supratube
Arm Description
Patient with orotracheal intubation and supratube device
Outcomes
Primary Outcome Measures
aspirated secretions
volume of aspirated secretions
Secondary Outcome Measures
Adverse events
Adverse events related to supratube device use
Full Information
NCT ID
NCT03573635
First Posted
May 31, 2018
Last Updated
July 9, 2018
Sponsor
Fundación Cardiovascular de Colombia
1. Study Identification
Unique Protocol Identification Number
NCT03573635
Brief Title
Continuous Supraglottic Aspiration in Intubated and Mechanically Ventilated Patients: the "SUPRAtube" Device
Acronym
Supratube
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
January 10, 2016 (Actual)
Primary Completion Date
December 12, 2017 (Actual)
Study Completion Date
December 20, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Cardiovascular de Colombia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aspiration Pneumonias
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Supratube
Arm Type
Other
Arm Description
Patient with orotracheal intubation and supratube device
Intervention Type
Device
Intervention Name(s)
Supratube
Intervention Description
Aspiration of orotracheal secretions with supratube device
Intervention Type
Other
Intervention Name(s)
Reference
Intervention Description
Usual aspiration with any other device
Primary Outcome Measure Information:
Title
aspirated secretions
Description
volume of aspirated secretions
Time Frame
24 hours after intubation
Secondary Outcome Measure Information:
Title
Adverse events
Description
Adverse events related to supratube device use
Time Frame
24 hours after intubation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
• Endotracheal intubation and invasive mechanical ventilation,
Exclusion Criteria:
Immediate postoperative oral cavity.
Traumatic oral cavity injury.
Platelet count less than 50000.
Facility Information:
Facility Name
Fundación Cardiovascular de Colombia
City
Piedecuesta
State/Province
Santander
ZIP/Postal Code
681011
Country
Colombia
12. IPD Sharing Statement
Learn more about this trial
Continuous Supraglottic Aspiration in Intubated and Mechanically Ventilated Patients: the "SUPRAtube" Device
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