Aspiration of Subglottic SecretionsNCT00450476
Aspiration of Subglottic Secretions Using Hi-Lo Evac Endotracheal Tube: Tube Size and Incidence of Suction Lumen Dysfunction
An observational study of Aspiration of Subglottic Secretions, run by University Hospital, Alexandroupolis at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Aspiration of Subglottic Secretions
- What is being tested?
- Hi-Lo Evac Endotracheal Tube
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteGreece
- Study dates
- Jan 2007to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Critically ill patients with orotracheal intubation and anticipated duration of intubation more than 48 hours
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
University General Hospital of Alexandroupolis
Alexandroupoli, Evros, 68100
Christos K Dragoumanis, MD, PhD
Vassilios Papaiannou, MD, PhD
About this study
Official title: Aspiration of Subglottic Secretions in Intubated Critically Ill Patients Using Hi-Lo Evac Endotracheal Tube: Correlation Between Tube Size and Incidence of Suction Lumen Dysfunction
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.
Read the 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.
- Conditions
- Aspiration of Subglottic Secretions
- Being tested
- Hi-Lo Evac Endotracheal Tube
- Keywords
- ventilator associated pneumonia, prevention, endotracheal intubation, mechanical ventilation
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hi-Lo Evac Endotracheal TubeDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2007 (estimated)
- Study startJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aspiration of Subglottic SecretionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Other
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Alexandroupolis
- Sponsor type
- University, hospital or other
- Investigators
- Christos K Dragoumanis, MD, PhD, Principal investigator, Intensive Care Unit, University Hospital of Alexandroupolis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00450476
- Sponsor's protocol ID
- 30/3/25-01-2007
- Status last verified
- Mar 2007
- First submitted
- 21 Mar 2007
- Last updated
- 22 Mar 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aspiration of Subglottic Secretions in Intubated Critically Ill Patients Using Hi-Lo Evac Endotracheal Tube: Correlation Between Tube Size and Incidence of Suction Lumen Dysfunction
- ClinicalTrials.gov ID
- NCT00450476
- Acronym / sponsor ID
- 30/3/25-01-2007
- Conditions
- Aspiration of Subglottic Secretions
- Keywords
- ventilator associated pneumonia, prevention, endotracheal intubation, mechanical ventilation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants
- Lead sponsor
- University Hospital, AlexandroupolisUniversity, hospital or other
- Study start
- Jan 2007
- First posted
- 22 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Critically ill patients with orotracheal intubation and anticipated duration of intubation more than 48 hours
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hi-Lo Evac Endotracheal Tube | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2007.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christos K Dragoumanis, MD, PhD principal investigator
Intensive Care Unit, University Hospital of Alexandroupolis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aspiration of Subglottic Secretions, run by University Hospital, Alexandroupolis at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christos K Dragoumanis, MD, PhD (00302551075085, christosdragoumanis@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2007.