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

Not Applicable

Completed

• Conditions: Aspiration Pneumonias
• Interventions: Device: Supratube; Other: Reference

• Registration Number: NCT03573635
• Lead Sponsor: Fundación Cardiovascular de Colombia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-10
• Primary Completion: 2017-12-12
• Study Completion: 2017-12-20
• Study First Submitted: 2018-05-31
• Study First Submitted QC: 2018-06-19
• Study First Posted: 2018-06-29
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-09
• Last Update Posted: 2018-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• Endotracheal intubation and invasive mechanical ventilation,

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supratube	Reference	Patient with orotracheal intubation and supratube device
Supratube	Supratube	Patient with orotracheal intubation and supratube device

Primary Outcome Measures

Name	Time	Method
aspirated secretions	24 hours after intubation	volume of aspirated secretions

Secondary Outcome Measures

Name	Time	Method
Adverse events	24 hours after intubation	Adverse events related to supratube device use

Trial Locations

Locations (1)

Fundación Cardiovascular de Colombia; 🇨🇴 Piedecuesta, Santander, Colombia