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

Aspiration Pneumonias Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03573635
• Other study ID #: 004
• Status: Completed
• Phase: N/A
• Start date: January 10, 2016
• Est. completion date: December 20, 2017

Study information

• Verified date: July 2018
• Source: Fundación Cardiovascular de Colombia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 20, 2017
• Est. primary completion date: December 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Endotracheal intubation and invasive mechanical ventilation,

Exclusion Criteria:

• Immediate postoperative oral cavity.

• Traumatic oral cavity injury.

• Platelet count less than 50000.

Related Conditions & MeSH terms

• Aspiration Pneumonias
• Pneumonia
• Pneumonia, Aspiration

Intervention

Device:
• Supratube
Aspiration of orotracheal secretions with supratube device

Other:
• Reference
Usual aspiration with any other device

Locations

Country	Name	City	State
Colombia	Fundación Cardiovascular de Colombia	Piedecuesta	Santander

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Cardiovascular de Colombia

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	aspirated secretions	volume of aspirated secretions	24 hours after intubation
Secondary	Adverse events	Adverse events related to supratube device use	24 hours after intubation