Pneumonia, Ventilator-AssociatedNCT01110109
Removing Fluid Above Breathing Tubes in the Operating Room
An observational study of Pneumonia, Ventilator-Associated, run by Medtronic - MITG at 1 site in United States.
Trial summary
In this study, subjects meeting criteria will be enrolled and randomized to one of two different suctioning schemes, either continuous or intermittent. Accumulated secretions will be collected above the cuff on the breathing tube by one of the two methods depending on which group the subject is randomized into. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Ventilator-Associated
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Oct 2010
- 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: Adults undergoing surgery requiring intubation using the TaperGuard EVAC Endotracehal Tube
Who may be able to join
- Surgery to be performed with expected time between tracheal intubation and extubation of at least two hours, but no longer than 12 hours
- Intubation planned with TaperGuard EVAC Endotracheal Tube
- Age of 18 or older
- Ability to provide informed consent
Who cannot join
- Presence of tracheostomy
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Tulane University Hospital
New Orleans, Louisiana, 70112
About this study
Official title: EVAC Use in the OR: A Randomized Clinical Study to Evaluate the Content of Fluid Extracted From the Endotracheal Tube Cuff Using Intermittent and Continuous Suctioning During Surgery
In this study, subjects meeting criteria will be enrolled and randomized to one of two different suctioning schemes, either continuous or intermittent. Accumulated secretions will be collected above the cuff on the breathing tube by one of the two methods depending on which group the subject is randomized into. Secretions will continue to be collected at predetermined periods of time for the duration of surgery in order to characterize the pH and volume as well as the micro-organism content.
Read the detailed description
The development of pneumonia and other infections from intubation in the intraoperative setting has not been well-studied. An understanding of the content of the fluid that accumulates above the cuff in this setting will further strengthen the relationship between intubation and infection. The purpose of this study is to characterize the content of fluid extracted from the endotracheal tube cuff during surgery. This study will also evaluate the content of the fluid across various intervals of suctioning.
Suctioning Schemes -
- Continuous Suctioning Anesthesia staff will suction secretions continuously at 20 mmHg with a safety stop of 5 seconds every 30 minutes. Staff will be responsible for monitoring the interval between each safety stop.
- Intermittent Suctioning Anesthesia staff will suction secretions intermittently using an intermittent suction regulator. The regulator will be set to suction at 100-150 mmHg. The regulator has a preset cycle of intermittent suctioning for 15 seconds with an 8 second pause.
This is a prospective randomized clinical study of 48 subjects at a single site in the United States. Those placing the tube and performing the suctioning schemes will be experienced study staff and have met all training requirements to ensure consistency. Subjects will be patients undergoing surgery requiring intubation using the TaperGuard Evac Endotracheal Tube for a minimum of two hours, but no longer than twelve hours. They must also be 18 years of age or older, able to provide consent and have no presence of tracheostomy. Pregnant subjects will also be excluded.
Suctioning will begin as soon as the tube is in place and will continue until extubation or until the patient is moved from the operating room, whichever comes earlier. Secretions will be collected in a Lukens Trap. Anesthesia staff will collect the accumulated secretions every 30 minutes for the duration of the surgery, and secretions will be processed according to the instructions provided in the sample collection kit.
To address the first objective of the study, the first and last sample obtained from each subject will be analyzed individually for pH, volume, and microorganisms; all other samples will be evaluated for volume. The amount of colony forming units (CFUs) will be determined semi-quantitatively across all organisms, and presented separately for individual genera and species. The samples will be characterized with descriptive statistics including frequencies, percentages, means, medians, standard deviations, and 95% CIs. To address the second objective of the study, comparisons of pH, volume, microorganisms, and CFUs by suctioning scheme and patient-level characteristics will be conducted using chi-squared tests of independence and analysis of variance (ANOVA). Graphical methods will be developed to aid interpretation, both as a function of time and cumulatively over time.
- Conditions
- Pneumonia, Ventilator-Associated
- Keywords
- Adult, Surgery, Endotracheal Tube, Ventilator, Pneumonia, Suctioning
- Medical subject headings
- Pneumonia, Ventilator-Associated, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Continuous Suctioning | Anesthesia staff will suction secretions continuously at 20 mmHg with a safety stop of 5 seconds every 30 minutes. | |
| Intermittent Suctioning | Anesthesia staff will suction secretions intermittently using an intermittent suction regulator. The regulator will be set to suction at 100-150 mmHg. The regulator has a preset cycle of intermittent suctioning for 15 seconds with an 8 second pause. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionSep 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia, Ventilator-AssociatedStudies of the same condition, open and under way.
- More trials run by Medtronic - MITGThe sponsor's other registered studies.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Francis A Rosinia, M.D., Principal investigator, Tulane University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01110109
- Sponsor's protocol ID
- COV-MO-PO-A111
- Status last verified
- Oct 2010
- First submitted
- 22 Apr 2010
- Last updated
- 26 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVAC Use in the OR: A Randomized Clinical Study to Evaluate the Content of Fluid Extracted From the Endotracheal Tube Cuff Using Intermittent and Continuous Suctioning During Surgery
- ClinicalTrials.gov ID
- NCT01110109
- Acronym / sponsor ID
- COV-MO-PO-A111
- Conditions
- Pneumonia, Ventilator-Associated
- Keywords
- Adult, Surgery, Endotracheal Tube, Ventilator, Pneumonia, Suctioning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 26 Apr 2010 (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.
In this study, subjects meeting criteria will be enrolled and randomized to one of two different suctioning schemes, either continuous or intermittent. Accumulated secretions will be collected above the cuff on the breathing tube by one of the two methods depending on which group the subject is randomized into. Secretions will continue to be collected at predetermined periods of time for the duration of surgery in order to characterize the pH and volume as well as the micro-organism content.
Detailed description
The development of pneumonia and other infections from intubation in the intraoperative setting has not been well-studied. An understanding of the content of the fluid that accumulates above the cuff in this setting will further strengthen the relationship between intubation and infection. The purpose of this study is to characterize the content of fluid extracted from the endotracheal tube cuff during surgery. This study will also evaluate the content of the fluid across various intervals of suctioning.
Suctioning Schemes -
- Continuous Suctioning Anesthesia staff will suction secretions continuously at 20 mmHg with a safety stop of 5 seconds every 30 minutes. Staff will be responsible for monitoring the interval between each safety stop.
- Intermittent Suctioning Anesthesia staff will suction secretions intermittently using an intermittent suction regulator. The regulator will be set to suction at 100-150 mmHg. The regulator has a preset cycle of intermittent suctioning for 15 seconds with an 8 second pause.
This is a prospective randomized clinical study of 48 subjects at a single site in the United States. Those placing the tube and performing the suctioning schemes will be experienced study staff and have met all training requirements to ensure consistency. Subjects will be patients undergoing surgery requiring intubation using the TaperGuard Evac Endotracheal Tube for a minimum of two hours, but no longer than twelve hours. They must also be 18 years of age or older, able to provide consent and have no presence of tracheostomy. Pregnant subjects will also be excluded.
Suctioning will begin as soon as the tube is in place and will continue until extubation or until the patient is moved from the operating room, whichever comes earlier. Secretions will be collected in a Lukens Trap. Anesthesia staff will collect the accumulated secretions every 30 minutes for the duration of the surgery, and secretions will be processed according to the instructions provided in the sample collection kit.
To address the first objective of the study, the first and last sample obtained from each subject will be analyzed individually for pH, volume, and microorganisms; all other samples will be evaluated for volume. The amount of colony forming units (CFUs) will be determined semi-quantitatively across all organisms, and presented separately for individual genera and species. The samples will be characterized with descriptive statistics including frequencies, percentages, means, medians, standard deviations, and 95% CIs. To address the second objective of the study, comparisons of pH, volume, microorganisms, and CFUs by suctioning scheme and patient-level characteristics will be conducted using chi-squared tests of independence and analysis of variance (ANOVA). Graphical methods will be developed to aid interpretation, both as a function of time and cumulatively over time.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous Suctioning | – | –Anesthesia staff will suction secretions continuously at 20 mmHg with a safety stop of 5 seconds every 30 minutes. |
| Intermittent Suctioning | – | –Anesthesia staff will suction secretions intermittently using an intermittent suction regulator. The regulator will be set to suction at 100-150 mmHg. The regulator has a preset cycle of intermittent suctioning for 15 seconds with an 8 second pause. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults undergoing surgery requiring intubation using the TaperGuard EVAC Endotracehal Tube
Key inclusion criteria (4 listed)
- Surgery to be performed with expected time between tracheal intubation and extubation of at least two hours, but no longer than 12 hours
- Intubation planned with TaperGuard EVAC Endotracheal Tube
- Age of 18 or older
- Ability to provide informed consent
Key exclusion criteria (2 listed)
- Presence of tracheostomy
- Pregnancy
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2010.
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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.
Francis A Rosinia, M.D. principal investigator
Tulane University Hospital
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, Ventilator-Associated, run by Medtronic - MITG 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 26 Oct 2010. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 26 Oct 2010.