Aspiration of Subglottic Secretions Using Hi-Lo Evac Endo... | NCT00450476

Studies
Aspiration of Subglottic Secretions Using Hi-Lo Evac Endotracheal Tube: Tube Size and Incidence of Suction Lumen Dysfunction

NCT00450476

Sponsor

University Hospital, Alexandroupolis

Status

Unknown status

Last Update Posted

Mar 22, 2007Estimated

Enrollment

Phase

Not provided

Conditions

Aspiration of Subglottic Secretions

Interventions

Hi-Lo Evac Endotracheal Tube

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Mar 21, 2007

First Submission Date that Met QC Criteria

Mar 21, 2007

First Posted Date

Mar 22, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 21, 2007

Last Update Posted Date

Mar 22, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To evaluate the correlation between endotracheal tube size and incidence of dysfunction of suction lumen of Hi-Lo Evac endotracheal tube in critically ill patients who required mechanical ventilation for more than 48 hours.

Detailed Description

In mechanically ventilated patients, aspiration of subglottic secretions is a widely used intervention for prevention of ventilator-associated pneumonia. Using Hi-Lo® Evac endotracheal tube (Hi-Lo Evac; Mallinckrodt; Athlone, Ireland), dysfunction of suction lumen and subsequent failure to aspirate the subglottic secretions is not uncommon. The objective of this prospective observational study is to determine the causes and the incidence of suction lumen dysfunction of Evac endotracheal tube.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Hi-Lo Evac Endotracheal Tube	Device

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Critically ill patients with orotracheal intubation and anticipated duration of intubation more than 48 hours

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Christos K Dragoumanis, MD, PhD	Contact	00302551075085		christosdragoumanis@gmail.com

Overall Officials

Name	Affiliation	Role
Christos K Dragoumanis, MD, PhD	Intensive Care Unit, University Hospital of Alexandroupolis	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University General Hospital of Alexandroupolis	Recruiting	Alexandroupoli	Evros	68100	Greece

Condition Browse Module

MeSH Terms

ID	Term
D053717	Pneumonia, Ventilator-Associated

Ancestor Terms

ID	Term
D000077299	Healthcare-Associated Pneumonia
D003428	Cross Infection
D007239	Infections
D011014	Pneumonia

Browse Leaves

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Browse Branches

Not provided