Patients Requiring Endotracheal IntubationNCT02171091
Intubated ICU Patients
An observational study of Patients Requiring Endotracheal Intubation, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this research study is to determine how cell changes during endotracheal intubation and artificial lung ventilation affect lung inflammation. Patients will undergo placement of an endotracheal tube (ETT) as standard of care. Tracheal (windpipe) lavage will be obtained each day for up to 72 hours. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Patients Requiring Endotracheal Intubation
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2016to 8 Aug 2017
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients receiving endotracheal intubation in the ICU
Who may be able to join
- Ages 18 to 85
- Required to have endotracheal intubation
- Admitted to an intensive care unit
Who cannot join
- On immunosuppressive medications
- Previous tracheal surgery
- On azithromycin
- Pregnancy
- Cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Impact of the Endotracheal Tube on Airway Inflammation: Prospective Analysis in Intubated ICU Patients
The purpose of this research study is to determine how cell changes during endotracheal intubation and artificial lung ventilation affect lung inflammation.
Patients will undergo placement of an endotracheal tube (ETT) as standard of care. Tracheal (windpipe) lavage will be obtained each day for up to 72 hours. Lung samples or fiberoptic (lung) samples will be collected at the same time intervals when possible and if they are done as standard of care.
Blood samples will be obtained simultaneous with the collection of the trachael (windpipe) specimens.
- Keywords
- endotracheal, intubation, airway, inflammation
- Medical subject headings
- Inflammation
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 |
|---|---|---|
| study arm | One tracheal sample will be obtained using sterile (5 ml) sterile saline solution using irrigation and wall suction from each patient every day for 72 hours, total sampling time is approximately 10 seconds per specimen. Lung samples or fiberoptic obtained samples will be collected at same time intervals as the tracheal samples when possible and if they are done as standard of care. Samples will not be collected for research only and the time for this procedure will not be extended to collect extra tissue. A blood sample (10ml) will be collected simultaneously with the airway samples and also will be used for baseline control measurements. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neutrophil changes
Identifying indicators of neutrophil inflammatory changes that occur during 72 hours of tracheal injury secondary to endotracheal intubation.
Measured: 72 hours
Secondary outcomes (3)
analyze neutrophil activation
Analyze neutrophil activation in the distal airways in biological samples obtained simultaneously with tracheal samples and to correlate them with the development of lung inflammation.
Measured: 72 hours
correlate tracheal and lung neutrophil activation
Correlate tracheal and lung neutrophil activation with development of pneumonia in ICU patients requiring mechanical ventilation.
Measured: 72 hours
determine the impact of airway (tracheal, lung) inflammation
Determine the impact of airway (tracheal, lung) inflammation as determined by neutrophil activation on the length of stay (LOS), discharge, and readmission to ICU in the first 90 days post airway inflammation (VAP) diagnosis.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study start1 Dec 2016
- Primary completion4 Aug 2017
- Study completion8 Aug 2017
Why it stopped: Principal investigator leaving Washington University and halting studies
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Requiring Endotracheal IntubationStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlos Puyo, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02171091
- Sponsor's protocol ID
- 201404106
- Status last verified
- Nov 2018
- First submitted
- 19 Jun 2014
- Last updated
- 15 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Endotracheal Tube on Airway Inflammation: Prospective Analysis in Intubated ICU Patients
- ClinicalTrials.gov ID
- NCT02171091
- Acronym / sponsor ID
- 201404106
- Keywords
- endotracheal, intubation, airway, inflammation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Principal investigator leaving Washington University and halting studies
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 4 Aug 2017 (actual)
- Study completion
- 8 Aug 2017 (actual)
- First posted
- 23 Jun 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.
The purpose of this research study is to determine how cell changes during endotracheal intubation and artificial lung ventilation affect lung inflammation.
Patients will undergo placement of an endotracheal tube (ETT) as standard of care. Tracheal (windpipe) lavage will be obtained each day for up to 72 hours. Lung samples or fiberoptic (lung) samples will be collected at the same time intervals when possible and if they are done as standard of care.
Blood samples will be obtained simultaneous with the collection of the trachael (windpipe) specimens.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study arm | – | –One tracheal sample will be obtained using sterile (5 ml) sterile saline solution using irrigation and wall suction from each patient every day for 72 hours, total sampling time is approximately 10 seconds per specimen. Lung samples or fiberoptic obtained samples will be collected at same time intervals as the tracheal samples when possible and if they are done as standard of care. Samples will not be collected for research only and the time for this procedure will not be extended to collect extra tissue. A blood sample (10ml) will be collected simultaneously with the airway samples and also will be used for baseline control measurements. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients receiving endotracheal intubation in the ICU
Key inclusion criteria (3 listed)
- Ages 18 to 85
- Required to have endotracheal intubation
- Admitted to an intensive care unit
Key exclusion criteria (5 listed)
- On immunosuppressive medications
- Previous tracheal surgery
- On azithromycin
- Pregnancy
- Cancer
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
Neutrophil changes
Time frame: 72 hours
Identifying indicators of neutrophil inflammatory changes that occur during 72 hours of tracheal injury secondary to endotracheal intubation.
3 secondary outcomes
analyze neutrophil activation
Time frame: 72 hours
correlate tracheal and lung neutrophil activation
Time frame: 72 hours
determine the impact of airway (tracheal, lung) inflammation
Time frame: 72 hours
Results and safety
The study was stopped early (reason given: Principal investigator leaving Washington University and halting studies). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2018.
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Effect of a FLUid Bolus or a Low Dose VAsopressor Infusion on Cardiovascular Collapse Among Critically Ill Adults Undergoing Tracheal Intubation.
Critically Ill Adults in the ICU, Requiring Endotracheal Intubation
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.
Carlos Puyo, MD principal investigator
Washington University School of Medicine
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 Patients Requiring Endotracheal Intubation, run by Washington University School of Medicine 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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 15 Nov 2018. 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 stopped early (reason given: Principal investigator leaving Washington University and halting studies). Results are not available in the source record.
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?
Neutrophil changes (time frame: 72 hours). 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 15 Nov 2018; AzTrials last refreshed its copy on 28 Oct 2026.