AnesthesiaNCT00862797
Pressure Course in the Tube Cuff During Swallowing
An observational study of Anesthesia and Intensive Care, run by University Hospital Freiburg at 1 site in Germany.
Trial summary
Leakage of fluid from the subglottic space to the lungs occurs along the longitudinal folds within the wall of endotracheal tube (ETT) cuffs. In this project the researchers investigate the possible effect of swallowing on the pressure course in the ETT cuff. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Intensive Care
- What is being tested?
- pressure measurement during swallowing
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2008to May 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients recovering from general anaesthesia or intensive care patients both intubated with cuffed endotracheal tubes
Who may be able to join
- age over 18 years
- general anaesthesia or intensive care medicine treatment
Who cannot join
- refusal of written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Leakage of fluid from the subglottic space to the lungs occurs along the longitudinal folds within the wall of endotracheal tube (ETT) cuffs. In this project the researchers investigate the possible effect of swallowing on the pressure course in the ETT cuff.
- Conditions
- Anesthesia, Intensive Care
- Being tested
- pressure measurement during swallowing
- Keywords
- endotracheal tube, swallowing, aspiration, cuff pressure, pneumonia
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pressure measurement during swallowingOther
measurement of endotracheal tube cuff pressure during swallowing while recovering from anaesthesia
| Study group | Role | What they receive |
|---|---|---|
| endotracheal tube | Patients intubated with cuffed endotracheal tubes Receives: Other: pressure measurement during swallowing |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2009 (estimated)
- Study startJan 2008
- Primary completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Freiburg
- Sponsor type
- University, hospital or other
- Investigators
- Daniel Steinmann, MD, Principal investigator, University Medical Center Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00862797
- Sponsor's protocol ID
- 273/07
- Status last verified
- Mar 2009
- First submitted
- 16 Mar 2009
- Last updated
- 2 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pressure Course in the Tube Cuff During Swallowing
- ClinicalTrials.gov ID
- NCT00862797
- Acronym / sponsor ID
- 273/07
- Conditions
- Anesthesia, Intensive Care
- Keywords
- endotracheal tube, swallowing, aspiration, cuff pressure, pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital FreiburgUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- May 2009 (actual)
- First posted
- 17 Mar 2009 (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.
Leakage of fluid from the subglottic space to the lungs occurs along the longitudinal folds within the wall of endotracheal tube (ETT) cuffs. In this project the researchers investigate the possible effect of swallowing on the pressure course in the ETT cuff.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| endotracheal tube | – | Other: pressure measurement during swallowingPatients intubated with cuffed endotracheal tubes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients recovering from general anaesthesia or intensive care patients both intubated with cuffed endotracheal tubes
Key inclusion criteria (2 listed)
- age over 18 years
- general anaesthesia or intensive care medicine treatment
Key exclusion criteria (1 listed)
- refusal of written informed consent
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 |
|---|---|---|
| pressure measurement during swallowingmeasurement of endotracheal tube cuff pressure during swallowing while recovering from anaesthesia | Other | endotracheal tube |
Primary outcome
Not reported in the source record.
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 2 Feb 2010.
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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.
Daniel Steinmann, MD principal investigator
University Medical Center Freiburg
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 Anesthesia and Intensive Care, run by University Hospital Freiburg at 1 site in Germany.
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 2 Feb 2010. 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 Germany. 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.
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 2 Feb 2010.