Endotracheal Tube Cuff Pressure Pediatric EmergencyNCT02160522
Endotracheal Tube (ETT) Cuff Pressure Study in the Emergency Department (ED)
An observational study of Endotracheal Tube Cuff Pressure Pediatric Emergency, run by Edward Ferenczy at 1 site in United States.
Trial summary
Our study will measure the pressure of the endotracheal tube cuff in intubated patients in the emergency department. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Endotracheal Tube Cuff Pressure Pediatric Emergency
- What is being tested?
- Cuffed ETT
- Type of treatment
- Medical device
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Jun 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients that are intubated with a cuffed endotracheal tube in the emergency department of Nationwide Children's Hospital.
Who may be able to join
- cuffed ETT in place on arrival in the ED
- cuffed ETT placed while in the ED
Who cannot join
- ETT cuff electively left deflated by practitioner
- Uncuffed ETT used
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: Endotracheal Tube Cuff Pressure in the Pediatric Emergency Department: A Pilot Study
Our study will measure the pressure of the endotracheal tube cuff in intubated patients in the emergency department.
Read the detailed description
Although manometers are available for the purpose of measuring ETT intra-cuff pressures, they are not currently in use at our institution's Emergency Department. This prospective cohort study will endeavor to determine the incidence of unacceptably high ETT cuff pressures in the ED, laying the foundation for follow up studies on patient outcomes and the potential need for more careful management of intra-cuff pressures in the ED.
- Being tested
- Cuffed ETT
- Keywords
- Intubation, cuff, cuffed, endotracheal, tube, pressure, pediatric, child, children, emergency
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cuffed ETTDevice
Measurement of the cuff pressure on an endotracheal tube and lower pressure to a safe range if it is elevated.
| Study group | Role | What they receive |
|---|---|---|
| Cuffed ETT | Patients that are intubated with a cuffed endotracheal tube. Receives: Device: Cuffed ETT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cuff pressure
One measurement of the ETT cuff pressure after intubation in the emergency department.
Measured: One time in the ED prior to discharge to the ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endotracheal Tube Cuff Pressure Pediatric EmergencyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edward Ferenczy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Edward Ferenczy, Nationwide Children's Hospital
- Investigators
- Edward Ferenczy, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02160522
- Sponsor's protocol ID
- IRB14-00215
- Status last verified
- Jun 2015
- First submitted
- 23 May 2014
- Last updated
- 8 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endotracheal Tube Cuff Pressure in the Pediatric Emergency Department: A Pilot Study
- ClinicalTrials.gov ID
- NCT02160522
- Acronym / sponsor ID
- IRB14-00215
- Keywords
- Intubation, cuff, cuffed, endotracheal, tube, pressure, pediatric, child
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Edward FerenczyUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 10 Jun 2014 (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.
Our study will measure the pressure of the endotracheal tube cuff in intubated patients in the emergency department.
Detailed description
Although manometers are available for the purpose of measuring ETT intra-cuff pressures, they are not currently in use at our institution's Emergency Department. This prospective cohort study will endeavor to determine the incidence of unacceptably high ETT cuff pressures in the ED, laying the foundation for follow up studies on patient outcomes and the potential need for more careful management of intra-cuff pressures in the ED.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cuffed ETT | – | Device: Cuffed ETTPatients that are intubated with a cuffed endotracheal tube. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients that are intubated with a cuffed endotracheal tube in the emergency department of Nationwide Children's Hospital.
Key inclusion criteria (2 listed)
- cuffed ETT in place on arrival in the ED
- cuffed ETT placed while in the ED
Key exclusion criteria (2 listed)
- ETT cuff electively left deflated by practitioner
- Uncuffed ETT used
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 ETTMeasurement of the cuff pressure on an endotracheal tube and lower pressure to a safe range if it is elevated. | Device | Cuffed ETT |
Primary outcome
Cuff pressure
Time frame: One time in the ED prior to discharge to the ICU
One measurement of the ETT cuff pressure after intubation in the emergency department.
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 8 Jun 2015.
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.
Edward Ferenczy, MD 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 Endotracheal Tube Cuff Pressure Pediatric Emergency, run by Edward Ferenczy 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 8 Jun 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?
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?
Cuff pressure (time frame: One time in the ED prior to discharge to the ICU). 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 8 Jun 2015.