NCT03573635

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2017

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2018

Completed
29 days until next milestone

First Posted

Study publicly available on registry

June 29, 2018

Completed
Last Updated

July 10, 2018

Status Verified

July 1, 2018

Enrollment Period

1.9 years

First QC Date

May 31, 2018

Last Update Submit

July 9, 2018

Conditions

Aspiration Pneumonias

Outcome Measures

Primary Outcomes (1)

  • aspirated secretions

    volume of aspirated secretions

    24 hours after intubation

Secondary Outcomes (1)

  • Adverse events

    24 hours after intubation

Study Arms (1)

Supratube

OTHER

Patient with orotracheal intubation and supratube device

Device: SupratubeOther: Reference

Interventions

SupratubeDEVICE

Aspiration of orotracheal secretions with supratube device

Supratube
ReferenceOTHER

Usual aspiration with any other device

Supratube

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Endotracheal intubation and invasive mechanical ventilation,

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundación Cardiovascular de Colombia

Piedecuesta, Santander Department, 681011, Colombia

Location

MeSH Terms

Conditions

Pneumonia, Aspiration

Condition Hierarchy (Ancestors)

PneumoniaRespiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2018

First Posted

June 29, 2018

Study Start

January 10, 2016

Primary Completion

December 12, 2017

Study Completion

December 20, 2017

Last Updated

July 10, 2018

Record last verified: 2018-07

Locations

CO(1)