Respiratory AspirationNCT01539135
The Influence of Endotracheal Tube Design on Fluid Leakage Into the Lungs During Surgery
A study testing Methylene Blue in people with Respiratory Aspiration, run by Medtronic - MITG at 1 site in United States.
Trial summary
Surgical patients have an endotracheal tube inserted into their windpipe to help them breathe while under general anesthesia. These tubes have a "cuff" on the outside that is inflated in the trachea to help prevent fluids from leaking into the lungs. These cuffs come in different shapes and sizes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Aspiration
- What is being tested?
- Methylene Blue
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to May 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female of all races
- Older than 18 years old
- Scheduled for an elective surgical procedure under general anesthesia for no less than 2hr and no more than 12hr with planned endotracheal intubation via the oral route
- Willing and able to give informed consent for participation in the study
- Anticipated extubation at the conclusion of general anesthesia in the operating room and prior to admission to the PACU
- Expected hospital stay of greater than or equal to 23hrs
Who cannot join
- Preexisting acute respiratory illness requiring antibiotic treatment within the two weeks prior to surgery
- Temperature of over 101 degrees F (38.3 C) at time of scheduled surgery
- Surgical requirement for naso-tracheal intubation
- Patients undergoing surgical procedures directly on the lungs, trachea, or airways
- Presence of tracheostomy
- History of allergic reaction to methylene blue
Show all 16Show fewer
- Methemoglobinemia, glucose-6-phosphate (G6PD) deficiency
- Renal insufficiency or failure
- Requirement for prolonged intubation and/or ventilation beyond the point of PACU admission
- Intraoperative use of nitrous oxide, to avoid the increase in cuff pressure due to diffusion of gas over time
- Psychiatric drugs of the following classifications: selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and monoamine oxidase inhibitors (MAOIs).
- Patients younger than 18 years of age
- Prone positioning during surgery
- Pregnant or lactating women based on standardized preoperative screening protocols
- Legally detained prisoner status
- Unwilling or unable to give informed consent for participation in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Tulane University Hospital and Clinics
New Orleans, Louisiana, 70112
About this study
Official title: The Influence of Endotracheal Tube Cuff Design on Intraoperative Microaspiration and Postoperative Respiratory Complications
Surgical patients have an endotracheal tube inserted into their windpipe to help them breathe while under general anesthesia. These tubes have a "cuff" on the outside that is inflated in the trachea to help prevent fluids from leaking into the lungs. These cuffs come in different shapes and sizes. The TaperGuard endotracheal tube has a taper-shaped cuff that has been shown in animals to decrease the leakage of fluid past the cuff better than a traditional tube that has a barrel-shaped cuff. This study is designed to examine whether the use of the TaperGuard tube during surgery on humans decreases the amount of leakage past the cuff to a greater degree than the traditional barrel-shaped cuff. In addition, the study will investigate whether the use of the TaperGuard tube is associated with a decrease in respiratory complications often seen following surgery which may be related to fluid leaking past the cuff and into the lungs. It is thought that the use of the TaperGuard endotracheal tube will result in a decrease in fluid leakage past the cuff and that it will be associated with a decrease in respiratory complications during the 30 days after surgery.
Read the detailed description
This study is designed to yield data on the intraoperative use of TaperGuard™endotracheal tubes and its potential influence on postoperative pulmonary complications and outcomes. The TaperGuard Basic tube has a taper-shaped cuff and has been shown, via bench and animal testing, to decrease microaspiration, which has been associated with respiratory difficulties. The intraoperative use of this tube (i.e. during short term intubation), and its impact on postoperative complications and outcomes has not been investigated. This study will determine whether the intraoperative use of the TaperGuard tube results in a decrease in microaspiration compared to the Hi-Lo endotracheal tube having a barrel-shaped cuff. Moreover, the relationship between a decrease in microaspiration and subsequent decrease in postoperative respiratory complications will be explored.
- Conditions
- Respiratory Aspiration
- Being tested
- Methylene Blue
- Keywords
- Aspiration, Respiratory
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylene BlueDrug
Also called Methylene Blue Dye
20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure
| Study group | Role | What they receive |
|---|---|---|
| Hi-Lo endotracheal tube | Active comparator | Hi-Lo endotracheal tube with barrel shaped cuff with 20 cc of methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure Receives: Drug: Methylene Blue |
| TaperGuard endotracheal tube | Experimental | TaperGuard endotracheal tube with taper shaped cuff with 20 cc methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure Receives: Drug: Methylene Blue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dye Leakage
Blue dye will be instilled above the endotracheal tube cuff immediately after intubation where it will remain for the duration of the surgery. The presence of dye leakage past the endotracheal tube cuff will be determined via analysis of bronchoscopic images taken at the end of the surgical procedure when surgical closure has begun.
Measured: Duration of surgical procedure - from 2 to 12 hours
Secondary outcomes (3)
Length of Hospital Stay
Time of readiness for discharge from PACU, defined as when an Aldrete score of greater than or equal to 8 is given, to the time at which discharge (from the hospital) orders are written. The inpatient period may extend up to 72 hours.
Measured: Time from discharge from PACU to discharge from hospital up to 72 hours
Number of Participants With Postoperative Pneumonia
Diagnosis of postoperative pneumonia during the 30 day follow up period after surgery
Measured: Up to 30 days after surgery
Number of Participants With Unanticipated Intensive Care Unit Admission
Incidence of unscheduled Intensive Care Unit admission after surgery and length of ICU stay if applicable.
Measured: Time from discharge from PACU to discharge from hospital up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2012 (estimated)
- Study startApr 2012
- Primary completionMay 2013
- Study completionMay 2013
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 Respiratory AspirationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sabrina Bent, MD, Principal investigator, Tulane University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01539135
- Sponsor's protocol ID
- COVAIPR0235
- Status last verified
- Aug 2015
- First submitted
- 6 Feb 2012
- Last updated
- 13 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Endotracheal Tube Cuff Design on Intraoperative Microaspiration and Postoperative Respiratory Complications
- ClinicalTrials.gov ID
- NCT01539135
- Acronym / sponsor ID
- COVAIPR0235
- Conditions
- Respiratory Aspiration
- Keywords
- Aspiration, Respiratory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 27 Feb 2012 (estimated)
- Results
- Posted 13 Aug 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Surgical patients have an endotracheal tube inserted into their windpipe to help them breathe while under general anesthesia. These tubes have a "cuff" on the outside that is inflated in the trachea to help prevent fluids from leaking into the lungs. These cuffs come in different shapes and sizes. The TaperGuard endotracheal tube has a taper-shaped cuff that has been shown in animals to decrease the leakage of fluid past the cuff better than a traditional tube that has a barrel-shaped cuff. This study is designed to examine whether the use of the TaperGuard tube during surgery on humans decreases the amount of leakage past the cuff to a greater degree than the traditional barrel-shaped cuff. In addition, the study will investigate whether the use of the TaperGuard tube is associated with a decrease in respiratory complications often seen following surgery which may be related to fluid leaking past the cuff and into the lungs. It is thought that the use of the TaperGuard endotracheal tube will result in a decrease in fluid leakage past the cuff and that it will be associated with a decrease in respiratory complications during the 30 days after surgery.
Detailed description
This study is designed to yield data on the intraoperative use of TaperGuard™endotracheal tubes and its potential influence on postoperative pulmonary complications and outcomes. The TaperGuard Basic tube has a taper-shaped cuff and has been shown, via bench and animal testing, to decrease microaspiration, which has been associated with respiratory difficulties. The intraoperative use of this tube (i.e. during short term intubation), and its impact on postoperative complications and outcomes has not been investigated. This study will determine whether the intraoperative use of the TaperGuard tube results in a decrease in microaspiration compared to the Hi-Lo endotracheal tube having a barrel-shaped cuff. Moreover, the relationship between a decrease in microaspiration and subsequent decrease in postoperative respiratory complications will be explored.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hi-Lo endotracheal tube | Active comparator | Drug: Methylene BlueHi-Lo endotracheal tube with barrel shaped cuff with 20 cc of methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure |
| TaperGuard endotracheal tube | Experimental | Drug: Methylene BlueTaperGuard endotracheal tube with taper shaped cuff with 20 cc methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or Female of all races
- Older than 18 years old
- Scheduled for an elective surgical procedure under general anesthesia for no less than 2hr and no more than 12hr with planned endotracheal intubation via the oral route
- Willing and able to give informed consent for participation in the study
- Anticipated extubation at the conclusion of general anesthesia in the operating room and prior to admission to the PACU
Key exclusion criteria (16 listed)
- Preexisting acute respiratory illness requiring antibiotic treatment within the two weeks prior to surgery
- Temperature of over 101 degrees F (38.3 C) at time of scheduled surgery
- Surgical requirement for naso-tracheal intubation
- Patients undergoing surgical procedures directly on the lungs, trachea, or airways
- Presence of tracheostomy
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 |
|---|---|---|
| Methylene BlueAlso: Methylene Blue Dye20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure | Drug | Hi-Lo endotracheal tube, TaperGuard endotracheal tube |
Primary outcome
Number of Participants With Dye Leakage
Time frame: Duration of surgical procedure - from 2 to 12 hours
Blue dye will be instilled above the endotracheal tube cuff immediately after intubation where it will remain for the duration of the surgery. The presence of dye leakage past the endotracheal tube cuff will be determined via analysis of bronchoscopic images taken at the end of the surgical procedure when surgical closure has begun.
3 secondary outcomes
Length of Hospital Stay
Time frame: Time from discharge from PACU to discharge from hospital up to 72 hours
Number of Participants With Postoperative Pneumonia
Time frame: Up to 30 days after surgery
Number of Participants With Unanticipated Intensive Care Unit Admission
Time frame: Time from discharge from PACU to discharge from hospital up to 72 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2015.
- 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.
Sabrina Bent, MD principal investigator
Tulane University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methylene Blue in people with Respiratory Aspiration, 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 6 inclusion and 16 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 13 Aug 2015. 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?
Yes. Results are posted in the registry (first posted 13 Aug 2015). 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?
Number of Participants With Dye Leakage (time frame: Duration of surgical procedure - from 2 to 12 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 13 Aug 2015.