Intracuff PressureNCT02376101
Minimal Occlusive Pressure With Cuffed ETT: the Effect of Size on Intracuff Pressure
A study testing Surgery less than 60 minutes in people with Intracuff Pressure and ETT Size, run by Senthil G. Krishna.
Trial summary
The purpose of this current study is to evaluate whether the size of the endotracheal tube (ETT) that is used impacts the intracuff pressure that occurs when the airway is sealed. Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Intracuff Pressure, ETT Size
- What is being tested?
- Surgery less than 60 minutes
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Jul 2016
- 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 4 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients requiring intubation with an ETT for a surgical procedure.
- Children ages 4 to 8 years old.
- Surgical procedure lasting less than 60 minutes.
Who cannot join
- Patients undergoing a surgical procedure that is anticipated to last longer than 60 minutes.
- Patients that are known or anticipated to have a difficult airway.
About this study
The purpose of this current study is to evaluate whether the size of the endotracheal tube (ETT) that is used impacts the intracuff pressure that occurs when the airway is sealed. If there is excessive pressure in the cuff of a smaller ETT when it is inflated, there may be inherent risks associated with the use of a cuffed endotracheal tube that is less than the appropriate size. The investigators believe that the size of the tube chosen has an impact on the characteristics of the inflated cuff and hence the intracuff pressure and the sealing pressure are variable.
- Conditions
- Intracuff Pressure, ETT Size
- Being tested
- Surgery less than 60 minutes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery less than 60 minutesProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Standard ETT size | Active comparator | Their tracheas will be intubated with an appropriately sized ETT using the standard formula. The cuff will be inflated to achieve a seal by the air-leak test when holding CPAP of 20 cmH2O and the intracuff pressure will be measured using a manometer. Receives: Procedure: Surgery less than 60 minutes |
| ETT one size smaller | Experimental | Their tracheas will be intubated with an ETT that is one size smaller (instead of a 5.0 ETT, we would use a 4.0 ETT). The cuff will be inflated to achieve a seal by the air-leak test when holding CPAP of 20 cmH2O and the intracuff pressure will be measured using a manometer. Receives: Procedure: Surgery less than 60 minutes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracuff pressure
Our goal is to measure the intracuff pressure that is achieved when the airway is sealed with an ETT based on the formula (ETT=(age/4)+3) and compare it to the intracuff pressure when the airway is sealed with an ETT that is 1 size smaller (4.0 mm instead of 5.0 mm).
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startOct 2014
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracuff PressureStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Senthil G. Krishna
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Senthil G. Krishna, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02376101
- Sponsor's protocol ID
- IRB14-00521
- Status last verified
- Aug 2016
- First submitted
- 24 Feb 2015
- Last updated
- 13 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimal Occlusive Pressure With Cuffed ETT: the Effect of Size on Intracuff Pressure
- ClinicalTrials.gov ID
- NCT02376101
- Acronym / sponsor ID
- IRB14-00521
- Conditions
- Intracuff Pressure, ETT Size
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Senthil G. KrishnaUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 3 Mar 2015 (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 current study is to evaluate whether the size of the endotracheal tube (ETT) that is used impacts the intracuff pressure that occurs when the airway is sealed. If there is excessive pressure in the cuff of a smaller ETT when it is inflated, there may be inherent risks associated with the use of a cuffed endotracheal tube that is less than the appropriate size. The investigators believe that the size of the tube chosen has an impact on the characteristics of the inflated cuff and hence the intracuff pressure and the sealing pressure are variable.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard ETT size | Active comparator | Procedure: Surgery less than 60 minutesTheir tracheas will be intubated with an appropriately sized ETT using the standard formula. The cuff will be inflated to achieve a seal by the air-leak test when holding CPAP of 20 cmH2O and the intracuff pressure will be measured using a manometer. |
| ETT one size smaller | Experimental | Procedure: Surgery less than 60 minutesTheir tracheas will be intubated with an ETT that is one size smaller (instead of a 5.0 ETT, we would use a 4.0 ETT). The cuff will be inflated to achieve a seal by the air-leak test when holding CPAP of 20 cmH2O and the intracuff pressure will be measured using a manometer. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients requiring intubation with an ETT for a surgical procedure.
- Children ages 4 to 8 years old.
- Surgical procedure lasting less than 60 minutes.
Key exclusion criteria (2 listed)
- Patients undergoing a surgical procedure that is anticipated to last longer than 60 minutes.
- Patients that are known or anticipated to have a difficult airway.
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 |
|---|---|---|
| Surgery less than 60 minutes | Procedure or surgery | ETT one size smaller, Standard ETT size |
Primary outcome
Intracuff pressure
Time frame: intraoperative
Our goal is to measure the intracuff pressure that is achieved when the airway is sealed with an ETT based on the formula (ETT=(age/4)+3) and compare it to the intracuff pressure when the airway is sealed with an ETT that is 1 size smaller (4.0 mm instead of 5.0 mm).
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 13 Sep 2016.
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.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery less than 60 minutes in people with Intracuff Pressure and ETT Size, run by Senthil G. Krishna.
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 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 13 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Intracuff pressure (time frame: intraoperative). 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 Sep 2016; AzTrials last refreshed its copy on 7 Nov 2026.