Patients Undergoing ENT Surgery With Cuffed ETTNCT01851317
The Relationship Between Patients' Head Position and ETT Intracuff Pressure
An observational study of Patients Undergoing ENT Surgery With Cuffed ETT, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
This study is designed to investigate the relationship between patients' position and endotracheal tube intracuff pressure in the pediatric population. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Patients Undergoing ENT Surgery With Cuffed ETT
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Apr 2014
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients undergoing otolaryngological surgery with cuffed endotracheal tube
Who may be able to join
- Age less than 18 years
- Undergoing otolaryngological surgery with endotracheal intubation
Who cannot join
- Patient who is intubated with an uncuffed endotracheal tube
- Patients who have a limitation for movement of the neck or concerns of the stability of the cervical spine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship Between Patients' Position and Endotracheal Tube Intracuff Pressure in Pediatric Population
This study is designed to investigate the relationship between patients' position and endotracheal tube intracuff pressure in the pediatric population.
Read the detailed description
There are currently no data in the literature as to the effect of changes in head position on CP. As the cuff is located in the patients' trachea, the shape of the patents' trachea may be change depending on the position of the patient's head and therefore, the CP may also change. If the intracuff pressure will increase as the patient's head is moved into a flexed or extended position, these patients may be at risk for tracheal damage. The investigators will prospectively evaluate the relationship between the patient's head position and CP in patients undergoing otolaryngological surgery.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Intracuff pressure | Procedure/Surgery: Cuffed endotracheal tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endotracheal tube intracuff pressure
An intracuff pressure ≥ 30 cmH2O may compromise the tracheal mucosal perfusion and result in tracheal damage.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Undergoing ENT Surgery With Cuffed ETTStudies 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hiromi Kako, M.D., Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01851317
- Sponsor's protocol ID
- IRB13-00243
- Status last verified
- Dec 2023
- First submitted
- 8 May 2013
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Patients' Position and Endotracheal Tube Intracuff Pressure in Pediatric Population
- ClinicalTrials.gov ID
- NCT01851317
- Acronym / sponsor ID
- IRB13-00243
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 10 May 2013 (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.
This study is designed to investigate the relationship between patients' position and endotracheal tube intracuff pressure in the pediatric population.
Detailed description
There are currently no data in the literature as to the effect of changes in head position on CP. As the cuff is located in the patients' trachea, the shape of the patents' trachea may be change depending on the position of the patient's head and therefore, the CP may also change. If the intracuff pressure will increase as the patient's head is moved into a flexed or extended position, these patients may be at risk for tracheal damage. The investigators will prospectively evaluate the relationship between the patient's head position and CP in patients undergoing otolaryngological surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intracuff pressure | – | –Procedure/Surgery: Cuffed endotracheal tube |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients undergoing otolaryngological surgery with cuffed endotracheal tube
Key inclusion criteria (2 listed)
- Age less than 18 years
- Undergoing otolaryngological surgery with endotracheal intubation
Key exclusion criteria (2 listed)
- Patient who is intubated with an uncuffed endotracheal tube
- Patients who have a limitation for movement of the neck or concerns of the stability of the cervical spine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Endotracheal tube intracuff pressure
Time frame: 1 day
An intracuff pressure ≥ 30 cmH2O may compromise the tracheal mucosal perfusion and result in tracheal damage.
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 Dec 2023.
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.
Hiromi Kako, M.D. principal investigator
Nationwide Children's Hospital
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 Patients Undergoing ENT Surgery With Cuffed ETT, 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 2 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 Dec 2023. 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?
Endotracheal tube intracuff pressure (time frame: 1 day). 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 Dec 2023.