Surgical Patients Intubated With Cuffed ETTNCT01384318
Accuracy of Using the CPAP Technique to Eliminate Air Leak and Prevent Excessive Endotracheal Tube Cuff Pressures
An observational study of Surgical Patients Intubated With Cuffed ETT, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
In common clinical practice, one means of ensuring an acceptable cuff pressure in endotracheal tubes (ETT) is to hold continuous positive airway pressure (CPAP) of 20-25 cmH2O and inflate the cuff of the ETT until no gas leak is noted around the cuff. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Surgical Patients Intubated With Cuffed ETT
- What is being tested?
- Manometer
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to May 2012
- 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 intubated with cuffed ETTs.
Who may be able to join
- Having a cuffed ETT placed per treating anesthesiologist
- < 18 yrs of age.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
In common clinical practice, one means of ensuring an acceptable cuff pressure in endotracheal tubes (ETT) is to hold continuous positive airway pressure (CPAP) of 20-25 cmH2O and inflate the cuff of the ETT until no gas leak is noted around the cuff. The purpose of this study is to validate this technique by checking the intracuff pressure using a manometer after the cuff is inflated using the CPAP technique.
- Being tested
- Manometer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ManometerOther
Measuring cuff pressure
| Study group | Role | What they receive |
|---|---|---|
| Cuffed ETT | Patients intubated with cuffed endotracheal tubes. Receives: Other: Manometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cuff pressure
cm H2O measured by manometer
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Surgical Patients Intubated 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
- Principal investigator, Joseph D. Tobias, Nationwide Children's Hospital
- Investigators
- Joseph D Tobias, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01384318
- Sponsor's protocol ID
- IRB11-00414
- Status last verified
- Nov 2012
- First submitted
- 27 Jun 2011
- Last updated
- 30 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Eschertzhuber S, Salgo B, Schmitz A, Roth W, Frotzler A, Keller CH, Gerber AC, Weiss M. Cuffed endotracheal tubes in children reduce sevoflurane and medical gas consumption and related costs. Acta Anaesthesiol Scand. 2010 Aug;54(7):855-8. doi: 10.1111/j.1399-6576.2010.02261.x. Epub 2010 Jun 15.
PubMed 20560884Weiss M, Dullenkopf A, Fischer JE, Keller C, Gerber AC; European Paediatric Endotracheal Intubation Study Group. Prospective randomized controlled multi-centre trial of cuffed or uncuffed endotracheal tubes in small children. Br J Anaesth. 2009 Dec;103(6):867-73. doi: 10.1093/bja/aep290. Epub 2009 Nov 3.
PubMed 19887533Weiss M, Dullenkopf A. Cuffed tracheal tubes in children: past, present and future. Expert Rev Med Devices. 2007 Jan;4(1):73-82. doi: 10.1586/17434440.4.1.73.
PubMed 17187473
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Using the CPAP Technique to Eliminate Air Leak and Prevent Excessive Endotracheal Tube Cuff Pressures
- ClinicalTrials.gov ID
- NCT01384318
- Acronym / sponsor ID
- IRB11-00414
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 29 Jun 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.
In common clinical practice, one means of ensuring an acceptable cuff pressure in endotracheal tubes (ETT) is to hold continuous positive airway pressure (CPAP) of 20-25 cmH2O and inflate the cuff of the ETT until no gas leak is noted around the cuff. The purpose of this study is to validate this technique by checking the intracuff pressure using a manometer after the cuff is inflated using the CPAP technique.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cuffed ETT | – | Other: ManometerPatients intubated with cuffed endotracheal tubes. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients intubated with cuffed ETTs.
Key inclusion criteria (2 listed)
- Having a cuffed ETT placed per treating anesthesiologist
- < 18 yrs of age.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| ManometerMeasuring cuff pressure | Other | Cuffed ETT |
Primary outcome
Cuff pressure
Time frame: Baseline
cm H2O measured by manometer
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 30 Nov 2012.
- Background: PubMed 20560884Eschertzhuber S, Salgo B, Schmitz A, Roth W, Frotzler A, Keller CH, Gerber AC, Weiss M. Cuffed endotracheal tubes in children reduce sevoflurane and medical gas consumption and related costs. Acta Anaesthesiol Scand. 2010 Aug;54(7):855-8. doi: 10.1111/j.1399-6576.2010.02261.x. Epub 2010 Jun 15.
- Background: PubMed 19887533Weiss M, Dullenkopf A, Fischer JE, Keller C, Gerber AC; European Paediatric Endotracheal Intubation Study Group. Prospective randomized controlled multi-centre trial of cuffed or uncuffed endotracheal tubes in small children. Br J Anaesth. 2009 Dec;103(6):867-73. doi: 10.1093/bja/aep290. Epub 2009 Nov 3.
- Background: PubMed 17187473Weiss M, Dullenkopf A. Cuffed tracheal tubes in children: past, present and future. Expert Rev Med Devices. 2007 Jan;4(1):73-82. doi: 10.1586/17434440.4.1.73.
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.
Joseph D Tobias, 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 Surgical Patients Intubated 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 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 30 Nov 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?
Cuff pressure (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01384318, which also lists 3 linked publications.
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 30 Nov 2012.