Surgical Procedure, UnspecifiedNCT04061629
Minimal Occlusive Pressure With Cuffed ETTs: The Effect of 3 Different Sizes of cETT on Intracuff Pressure in Children
An observational study of Surgical Procedure, Unspecified, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
Based on standard and historical practice, the predictive size of the endotracheal tube (ETT) to be used in children has been based on various formulas. However, no study has clearly compared these formulas to determine the optimal size of cuffed ETTs. Read more about this study
- Who is it for?
- Ages Up to 8 years
- Conditions the study is for
- Surgical Procedure, Unspecified
- What is being tested?
- Cuffed ETT
- Type of treatment
- Medical device
- How many people
- 147 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2017to 18 Jul 2019
- 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 Up to 8 years
- All sexes
- No healthy volunteers
- Child
Study population: Children requiring an endotracheal tube for surgery.
Who may be able to join
- Children who are less than 8 years of age and are scheduled for surgical procedures requiring endotracheal intubation with a cuffed ETT.
Who cannot join
- Children with airway anomalies or other factors that may impact tracheal size will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Based on standard and historical practice, the predictive size of the endotracheal tube (ETT) to be used in children has been based on various formulas. However, no study has clearly compared these formulas to determine the optimal size of cuffed ETTs. Furthermore, they were developed when using a polyvinylchloride cuff and not the thinner polyurethane cuff which is in common clinical use today. Hence, the purpose of this current study is to evaluate which of the currently available formulas most closely predicts the appropriate size of cuffed ETT to be used based not only on the fit within the trachea, but more importantly the intracuff pressure after the cuff is inflated to seal the airway.
- Conditions
- Surgical Procedure, Unspecified
- Being tested
- Cuffed ETT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cuffed ETTDevice
Cuffed endotracheal tube.
| Study group | Role | What they receive |
|---|---|---|
| Group C | Size of the cuffed ETT based on the Cole formula = (Age/4) + 4. Receives: Device: Cuffed ETT | |
| Group D | size of the cuffed ETT based on the Duracher formula = (Age/4) + 3 + 0.5 mm. Receives: Device: Cuffed ETT | |
| Group K | size of the cuffed ETT based on the Khine formula = (Age/4) + 3. Receives: Device: Cuffed ETT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants that needed their ETT exchanged
Having to remove the original ETT and replacing it with a smaller or larger size due to excessive air leak or excessive pressure in the cuff.
Measured: Immediately following intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study start18 Sep 2017
- Primary completion18 Jul 2019
- Study completion18 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Procedure, UnspecifiedStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Senthil G. Krishna, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04061629
- Sponsor's protocol ID
- IRB17-00700
- Status last verified
- Feb 2020
- First submitted
- 16 Aug 2019
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimal Occlusive Pressure With Cuffed ETTs: The Effect of 3 Different Sizes of cETT on Intracuff Pressure in Children
- ClinicalTrials.gov ID
- NCT04061629
- Acronym / sponsor ID
- IRB17-00700
- Conditions
- Surgical Procedure, Unspecified
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- 18 Sep 2017 (actual)
- Primary completion
- 18 Jul 2019 (actual)
- Study completion
- 18 Jul 2019 (actual)
- First posted
- 20 Aug 2019 (actual)
- 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.
Based on standard and historical practice, the predictive size of the endotracheal tube (ETT) to be used in children has been based on various formulas. However, no study has clearly compared these formulas to determine the optimal size of cuffed ETTs. Furthermore, they were developed when using a polyvinylchloride cuff and not the thinner polyurethane cuff which is in common clinical use today. Hence, the purpose of this current study is to evaluate which of the currently available formulas most closely predicts the appropriate size of cuffed ETT to be used based not only on the fit within the trachea, but more importantly the intracuff pressure after the cuff is inflated to seal the airway.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group C | – | Device: Cuffed ETTSize of the cuffed ETT based on the Cole formula = (Age/4) + 4. |
| Group D | – | Device: Cuffed ETTsize of the cuffed ETT based on the Duracher formula = (Age/4) + 3 + 0.5 mm. |
| Group K | – | Device: Cuffed ETTsize of the cuffed ETT based on the Khine formula = (Age/4) + 3. |
Who may qualify
- Ages
- Up to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children requiring an endotracheal tube for surgery.
Key inclusion criteria (1 listed)
- Children who are less than 8 years of age and are scheduled for surgical procedures requiring endotracheal intubation with a cuffed ETT.
Key exclusion criteria (1 listed)
- Children with airway anomalies or other factors that may impact tracheal size will be excluded from the study.
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 ETTCuffed endotracheal tube. | Device | Group C, Group D, Group K |
Primary outcome
Number of participants that needed their ETT exchanged
Time frame: Immediately following intubation
Having to remove the original ETT and replacing it with a smaller or larger size due to excessive air leak or excessive pressure in the cuff.
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 11 Feb 2020.
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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?
An observational study of Surgical Procedure, Unspecified, 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 11 Feb 2020. 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?
Number of participants that needed their ETT exchanged (time frame: Immediately following intubation). 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 11 Feb 2020.