PneumoniaNCT02311296
Reduced Ventilator-Free Days and Bacterial Colonization of Sub-Glottic Secretions
An observational study of Pneumonia, run by University of Tennessee, Chattanooga at 1 site in United States.
Trial summary
Ventilator associated pneumonia (VAP) is common problem among ICU patients and major source of infection among patients receiving mechanical ventilation. Patients on mechanical ventilation accumulate secretion leading to aspiration of infected secretions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2020to 2 Nov 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients on mechanical ventilation
Who may be able to join
- Age > 18 years of age
- Patients requiring mechanical ventilation for altered mental status, drug overdose or any condition that airway protection from aspiration is clinically warranted
- Patients requiring mechanical ventilation following Cardiothoracic bypass or valve replacement surgery
- Patients requiring mechanical ventilation for stroke, intra-cranial bleed, sub-dural hematoma, meningitis or closed head injury
- Patients requiring mechanical ventilation for following of abdominal surgery in which there were no discernable infiltrates on chest X-ray
- Patients requiring mechanical ventilation for primary lung disease (COPD, emphysema etc.) if no discernable infiltrates on chest X-ray.
Who cannot join
- 1) Patients receiving mechanical ventilation for greater than 6 hrs at the time of enrollment.
- 2) Patients requiring mechanical ventilation for ARDS, pneumonia or traumatic lung injury.
- 3) Patients receiving more than one dose of any antibiotic.
- 4) Patients undergoing surgical resection for lung cancer or any other surgery directly involving lung parenchyma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Bacterial Colonization and Extracellular HSP-70 Expression in Sub-Glottic Secretions on Ventilator Free Days in Patients Receiving Mechanical Ventilation for Respiratory Failure or Airway Protection
Ventilator associated pneumonia (VAP) is common problem among ICU patients and major source of infection among patients receiving mechanical ventilation. Patients on mechanical ventilation accumulate secretion leading to aspiration of infected secretions. Using new generation endotracheal tube (Hi-Lo tube) can reduce the incidence of VAP.
Read the detailed description
All patients secrete fluids into the upper airway from the base of our tongue and other related structures. These "subglottic" secretions are normally cleared by swallowing, but when a person requires mechanical ventilation that process is blocked by the breathing tube and the subglottic secretions tend to accumulate. The removal of these subglottic secretions is very important because bacteria that normally inhabit the back of our throats can enter and ultimately colonize collected pools of subglottic secretions. This process is called "micro-aspiration" and has been shown to be strong risk factor for the development of Ventilator associated pneumonia (VAP). Previously, doctors and nurses would attempt to limit these secretions by passing small suction tubes through the breathing tube, but this was found to be ineffective and increased the risk for bleeding and lung injury.
A new development in the management of patients requiring mechanical ventilation is the Hi-Lo endotracheal tube. This device has "suction ports" on either side of the tube that allow for the removal of accumulated subglottic secretions.The standard of care is to use this Hi-Lo ET tube and to remove subglottic secretions every 4-6 hours. The Hi-Lo tube is designed to minimize any suction related trauma. Moreover, recent studies of this ET tube have shown that regular suctioning reduces the incidence of VAP. When these "colonized" secretions were treated with antibiotics, it reduced the number of VAP and shortened the time on the breathing machine. The observation that treatment of bacterial colonization of subglottic secretions reduced the time on the breathing machine is potentially very important clinically. In this study, we propose that the development of bacterial colonization directly contributes to respiratory failure and leads to longer times on the ventilator. The primary aim of the study could lead to reduce the time that patients need mechanical ventilation.
Recent studies have identified a group of "protective proteins" called the heat shock proteins (HSP) that appear to protect patients from developing pneumonia. The protective effect of these proteins is even more pronounced in patients that require mechanical ventilation. Under stressed conditions, HSPs are secreted or released into the subglottic secretions and the level of secretion is sufficient appears to prevent bacteria from "colonizing" the upper respiratory tract.
In addition to looking at rates of bacterial colonization of these secretions, a portion of these secretions to measure the amount of HSP and whether reduced secretion leads to prolonged time on the ventilator.
- Conditions
- Pneumonia
- Medical subject headings
- Pneumonia
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine time course and incidence of bacterial colonization of subglottic secretions
Measured: first 72 hours of receiving mechanical ventilation
Secondary outcomes (1)
Patients with bacterial colony counts greater than Log(10)4 after 72 hours
Measured: after 72 hours of ventilation have reduction of ventilator free days at Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study start2 Nov 2020
- Primary completion2 Nov 2020
- Study completion2 Nov 2020
Why it stopped: Study registered to wrong sponsor.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee, Chattanooga
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Gunter, MD, Principal investigator, University of Tennessee, Chattanooga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02311296
- Sponsor's protocol ID
- HI-LO Study
- Status last verified
- Nov 2020
- First submitted
- 13 May 2014
- Last updated
- 25 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bacterial Colonization and Extracellular HSP-70 Expression in Sub-Glottic Secretions on Ventilator Free Days in Patients Receiving Mechanical Ventilation for Respiratory Failure or Airway Protection
- ClinicalTrials.gov ID
- NCT02311296
- Acronym / sponsor ID
- HI-LO Study
- Conditions
- Pneumonia
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study registered to wrong sponsor.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Tennessee, ChattanoogaUniversity, hospital or other
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 2 Nov 2020 (actual)
- Study completion
- 2 Nov 2020 (actual)
- First posted
- 8 Dec 2014 (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.
Ventilator associated pneumonia (VAP) is common problem among ICU patients and major source of infection among patients receiving mechanical ventilation. Patients on mechanical ventilation accumulate secretion leading to aspiration of infected secretions. Using new generation endotracheal tube (Hi-Lo tube) can reduce the incidence of VAP.
Detailed description
All patients secrete fluids into the upper airway from the base of our tongue and other related structures. These "subglottic" secretions are normally cleared by swallowing, but when a person requires mechanical ventilation that process is blocked by the breathing tube and the subglottic secretions tend to accumulate. The removal of these subglottic secretions is very important because bacteria that normally inhabit the back of our throats can enter and ultimately colonize collected pools of subglottic secretions. This process is called "micro-aspiration" and has been shown to be strong risk factor for the development of Ventilator associated pneumonia (VAP). Previously, doctors and nurses would attempt to limit these secretions by passing small suction tubes through the breathing tube, but this was found to be ineffective and increased the risk for bleeding and lung injury.
A new development in the management of patients requiring mechanical ventilation is the Hi-Lo endotracheal tube. This device has "suction ports" on either side of the tube that allow for the removal of accumulated subglottic secretions.The standard of care is to use this Hi-Lo ET tube and to remove subglottic secretions every 4-6 hours. The Hi-Lo tube is designed to minimize any suction related trauma. Moreover, recent studies of this ET tube have shown that regular suctioning reduces the incidence of VAP. When these "colonized" secretions were treated with antibiotics, it reduced the number of VAP and shortened the time on the breathing machine. The observation that treatment of bacterial colonization of subglottic secretions reduced the time on the breathing machine is potentially very important clinically. In this study, we propose that the development of bacterial colonization directly contributes to respiratory failure and leads to longer times on the ventilator. The primary aim of the study could lead to reduce the time that patients need mechanical ventilation.
Recent studies have identified a group of "protective proteins" called the heat shock proteins (HSP) that appear to protect patients from developing pneumonia. The protective effect of these proteins is even more pronounced in patients that require mechanical ventilation. Under stressed conditions, HSPs are secreted or released into the subglottic secretions and the level of secretion is sufficient appears to prevent bacteria from "colonizing" the upper respiratory tract.
In addition to looking at rates of bacterial colonization of these secretions, a portion of these secretions to measure the amount of HSP and whether reduced secretion leads to prolonged time on the ventilator.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients on mechanical ventilation
Key inclusion criteria (6 listed)
- Age > 18 years of age
- Patients requiring mechanical ventilation for altered mental status, drug overdose or any condition that airway protection from aspiration is clinically warranted
- Patients requiring mechanical ventilation following Cardiothoracic bypass or valve replacement surgery
- Patients requiring mechanical ventilation for stroke, intra-cranial bleed, sub-dural hematoma, meningitis or closed head injury
- Patients requiring mechanical ventilation for following of abdominal surgery in which there were no discernable infiltrates on chest X-ray
Key exclusion criteria (4 listed)
- 1) Patients receiving mechanical ventilation for greater than 6 hrs at the time of enrollment.
- 2) Patients requiring mechanical ventilation for ARDS, pneumonia or traumatic lung injury.
- 3) Patients receiving more than one dose of any antibiotic.
- 4) Patients undergoing surgical resection for lung cancer or any other surgery directly involving lung parenchyma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine time course and incidence of bacterial colonization of subglottic secretions
Time frame: first 72 hours of receiving mechanical ventilation
1 secondary outcome
Patients with bacterial colony counts greater than Log(10)4 after 72 hours
Time frame: after 72 hours of ventilation have reduction of ventilator free days at Day 14
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2020.
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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.
John Gunter, MD principal investigator
University of Tennessee, Chattanooga
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 Pneumonia, run by University of Tennessee, Chattanooga at 1 site in United States.
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 6 inclusion and 4 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: withdrawn, as of the sponsor's last update on 25 Nov 2020. 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 United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine time course and incidence of bacterial colonization of subglottic secretions (time frame: first 72 hours of receiving mechanical ventilation). It is what the study was designed to measure, not a finding.
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 25 Nov 2020.