Patients Requiring Endotracheal IntubationNCT01815229
Role of Neutrophil Activation
A study testing tracheal lavages in people with Patients Requiring Endotracheal Intubation, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Patients will undergo placement of an endotracheal tube (ETT) as standard of care. Tracheal lavage will be conducted using 5 mL of sterile saline solution by a push/suction technique. Specimen samples obtained by wall suction will be collected at 2 time points following intubation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Patients Requiring Endotracheal Intubation
- What is being tested?
- tracheal lavages
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Jul 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18 to 65
- American Society of Anesthesiologists Physical Status Classification (ASA) I and II
- Required to have endotracheal intubation
- Scheduled for short admission (<23 hrs), or ambulatory orthopedic surgery (ankle, shoulder, or extremity surgery); general surgery (exploratory laparotomy, cholecystectomy, ventral or inguinal hernia repair); obstetric/gynecological surgery(total abdominal hysterectomy, bilateral salpingo-oophorectomy); urologic surgery (nephrectomy, prostatectomy), lumbar spine surgery( discectomy, one or two level lumbar fusion) procedures.
- Estimated duration of surgery 3 to 4 hours.
- Provide informed consent
Who cannot join
- Active pulmonary disease within 5 days prior to enrollment
- On immunosuppressive medications
- Previous tracheal surgery
- On azithromycin
- Diabetes
- Pregnancy
Show all 13Show fewer
- Smoking history of less than 6 weeks prior to surgery
- Surgery or intubation within 5 days of surgery
- Planned surgical procedure involving neck or thoracic regions
- Active pulmonary disease
- Autoimmune disease (HIV, AIDS, Rheumatoid Arthritis
- Hepatitis
- 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: Sore Throat Secondary to Endotracheal Intubation: the Role of Neutrophil Activation
Patients will undergo placement of an endotracheal tube (ETT) as standard of care. Tracheal lavage will be conducted using 5 mL of sterile saline solution by a push/suction technique. Specimen samples obtained by wall suction will be collected at 2 time points following intubation.
Blood samples will be obtained at 2 time points, simultaneous with the collection of the tracheal specimens.
- Being tested
- tracheal lavages
- Keywords
- endotracheal, intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tracheal lavagesProcedure or surgery
tracheal lavages obtained during endotracheal intubation.
| Study group | Role | What they receive |
|---|---|---|
| tracheal lavages | Experimental | After the placement of the endotracheal tube (Hi-Lo™ Evac Mallinckrodt), tracheal lavages will be performed.
A simultaneous blood sample of approx 5cc, will be collected by venipuncture or by sampling from intravenous or arterial line if available. The same procedure for collection of tracheal sample and blood will be repeated at the end of the surgical procedure and immediately prior to removal of the ETT. A total of approx 10cc blood will be collected for research purposes. Receives: Procedure: tracheal lavages |
| Healthy Control | Placebo comparator | To replicate activation, neutrophils were isolated from 30mL blood of healthy volunteers and cocultured with TLF from subjects with or without sore throat pain. Receives: Procedure: tracheal lavages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neutrophil Cell Counts in Tracheal Lavages
Neutrophil cell count were collected after an average of 3.2 hours of exposure to an ETT. Cell counts were performed using 10x6 per ml
Measured: average of 3.2 hours of exposure to an ETT
Secondary outcomes (1)
Intubation Time in Minutes
Average amount of time that participants were intubated
Measured: Up to 363 minutes for intubation time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionJun 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 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
- NCT01815229
- Sponsor's protocol ID
- 201301037
- Status last verified
- May 2019
- First submitted
- 18 Mar 2013
- Last updated
- 15 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sore Throat Secondary to Endotracheal Intubation: the Role of Neutrophil Activation
- ClinicalTrials.gov ID
- NCT01815229
- Acronym / sponsor ID
- 201301037
- Keywords
- endotracheal, intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 20 Mar 2013 (estimated)
- Results
- Posted 15 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients will undergo placement of an endotracheal tube (ETT) as standard of care. Tracheal lavage will be conducted using 5 mL of sterile saline solution by a push/suction technique. Specimen samples obtained by wall suction will be collected at 2 time points following intubation.
Blood samples will be obtained at 2 time points, simultaneous with the collection of the tracheal specimens.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tracheal lavages | Experimental | Procedure: tracheal lavagesAfter the placement of the endotracheal tube (Hi-Lo™ Evac Mallinckrodt), tracheal lavages will be performed. A simultaneous blood sample of approx 5cc, will be collected by venipuncture or by sampling from intravenous or arterial line if available. The same procedure for collection of tracheal sample and blood will be repeated at the end of the surgical procedure and immediately prior to removal of the ETT. A total of approx 10cc blood will be collected for research purposes. |
| Healthy Control | Placebo comparator | Procedure: tracheal lavagesTo replicate activation, neutrophils were isolated from 30mL blood of healthy volunteers and cocultured with TLF from subjects with or without sore throat pain. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ages 18 to 65
- American Society of Anesthesiologists Physical Status Classification (ASA) I and II
- Required to have endotracheal intubation
- Scheduled for short admission (<23 hrs), or ambulatory orthopedic surgery (ankle, shoulder, or extremity surgery); general surgery (exploratory laparotomy, cholecystectomy, ventral or inguinal hernia repair); obstetric/gynecological surgery(total abdominal hysterectomy, bilateral salpingo-oophorectomy); urologic surgery (nephrectomy, prostatectomy), lumbar spine surgery( discectomy, one or two level lumbar fusion) procedures.
- Estimated duration of surgery 3 to 4 hours.
Key exclusion criteria (13 listed)
- Active pulmonary disease within 5 days prior to enrollment
- On immunosuppressive medications
- Previous tracheal surgery
- On azithromycin
- Diabetes
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 |
|---|---|---|
| tracheal lavagestracheal lavages obtained during endotracheal intubation. | Procedure or surgery | Healthy Control, tracheal lavages |
Primary outcome
Neutrophil Cell Counts in Tracheal Lavages
Time frame: average of 3.2 hours of exposure to an ETT
Neutrophil cell count were collected after an average of 3.2 hours of exposure to an ETT. Cell counts were performed using 10x6 per ml
1 secondary outcome
Intubation Time in Minutes
Time frame: Up to 363 minutes for intubation time
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
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?
A study testing tracheal lavages in people with 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 6 inclusion and 13 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 15 Jul 2019. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 15 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Cell Counts in Tracheal Lavages (time frame: average of 3.2 hours of exposure to an ETT). 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 Jul 2019.