AdenoidectomyNCT01285804
Impact of Using a Cuffed Endotracheal Tube on Limiting the Risk of Airway Fire
A study testing Cuffed ETT and Uncuffed ETT in people with Adenoidectomy and Tonsillectomy, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the impact of using a cuffed endotracheal tube (ETT) on the oxygen concentration in the oropharynx during adenoidectomy, tonsillectomy, or adenotonsillectomy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Adenoidectomy, Tonsillectomy, Adenotonsillectomy
- What is being tested?
- Cuffed ETT and Uncuffed ETT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Nov 2011
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing adenoidectomy, tonsillectomy, or adenotonsillectomy.
Who cannot join
- Airway anomalies or cardiac conditions that have the potential for a complicated anesthesia induction.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
The purpose of this study is to evaluate the impact of using a cuffed endotracheal tube (ETT) on the oxygen concentration in the oropharynx during adenoidectomy, tonsillectomy, or adenotonsillectomy. The study hypothesis is that inflation of the cuff on the ETT will eliminate contamination of the oropharynx with the inspired anesthetic gases and decrease the oxygen concentration in the oropharynx.
- Conditions
- Adenoidectomy, Tonsillectomy, Adenotonsillectomy
- Being tested
- Cuffed ETT, Uncuffed ETT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cuffed ETTOther
Kimberly Clark
Uncuffed ETTOther
Kimberly Clark
| Study group | Role | What they receive |
|---|---|---|
| Cuffed ETT | Active comparator | Not described Receives: Other: Cuffed ETT |
| Uncuffed ETT | Active comparator | Not described Receives: Other: Uncuffed ETT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in oxygen concentration in the oropharynx between cuffed and uncuffed ETT.
The oxygen and sevoflurane (anesthetic agent) concentration of the oropharynx would be measured during positive pressure ventilation immediately after intubation and then 4-5 mins. after anesthetic induction when the patient resumes spontaneous ventilation.
Measured: 4-5 minutes after induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenoidectomyStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph D. Tobias, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01285804
- Sponsor's protocol ID
- IRB10-00487
- Status last verified
- Jan 2012
- First submitted
- 26 Jan 2011
- Last updated
- 31 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Using a Cuffed Endotracheal Tube on Limiting the Risk of Airway Fire
- ClinicalTrials.gov ID
- NCT01285804
- Acronym / sponsor ID
- IRB10-00487
- Conditions
- Adenoidectomy, Tonsillectomy, Adenotonsillectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 28 Jan 2011 (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 study is to evaluate the impact of using a cuffed endotracheal tube (ETT) on the oxygen concentration in the oropharynx during adenoidectomy, tonsillectomy, or adenotonsillectomy. The study hypothesis is that inflation of the cuff on the ETT will eliminate contamination of the oropharynx with the inspired anesthetic gases and decrease the oxygen concentration in the oropharynx.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cuffed ETT | Active comparator | Other: Cuffed ETT |
| Uncuffed ETT | Active comparator | Other: Uncuffed ETT |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing adenoidectomy, tonsillectomy, or adenotonsillectomy.
Key exclusion criteria (1 listed)
- Airway anomalies or cardiac conditions that have the potential for a complicated anesthesia induction.
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 |
|---|---|---|
| Cuffed ETTKimberly Clark | Other | Cuffed ETT |
| Uncuffed ETTKimberly Clark | Other | Uncuffed ETT |
Primary outcome
Difference in oxygen concentration in the oropharynx between cuffed and uncuffed ETT.
Time frame: 4-5 minutes after induction
The oxygen and sevoflurane (anesthetic agent) concentration of the oropharynx would be measured during positive pressure ventilation immediately after intubation and then 4-5 mins. after anesthetic induction when the patient resumes spontaneous ventilation.
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 31 Jan 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cuffed ETT and Uncuffed ETT in people with Adenoidectomy and Tonsillectomy, run by Nationwide Children's Hospital 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 1 inclusion and 1 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 31 Jan 2012. 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.
What does the primary outcome measure?
Difference in oxygen concentration in the oropharynx between cuffed and uncuffed ETT. (time frame: 4-5 minutes after induction). 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 31 Jan 2012.