Intubation, IntratrachealNCT01252173
Measurement Of Endotracheal Tube Cuff Pressure In Emergency Department Patients
An observational study of Intubation, Intratracheal, run by Beth Israel Medical Center.
Trial summary
The purpose of this research is to measure the endotracheal tube cuff pressure in patients who have been endotracheally intubated emergently in the emergency department or in the field by prehospital personnel. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intubation, Intratracheal
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2005to Sep 2006
- 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: All emergency department patients, and all patients admitted from the ED
Who may be able to join
- Patient emergently endotracheally intubated with a cuffed endotracheal tube.
Who cannot join
- Endotracheal intubation procedure performed in a setting other than the prehospital (field) or emergency department of participating institution. This specifically excludes endotracheally intubated patients transferred from another hospital, chronic care facility, or other location.
- Non-emergent or elective endotracheal intubation.
About this study
Official title: MEASUREMENT OF ENDOTRACHEAL TUBE CUFF PRESSURE IN EMERGENCY DEPARTMENT PATIENTS
The purpose of this research is to measure the endotracheal tube cuff pressure in patients who have been endotracheally intubated emergently in the emergency department or in the field by prehospital personnel. Overinflation of ETTc pressure is associated with injury, and we seek to determine if the phenomenon of excessively inflated ETTc can be detected in endotracheally intubated patients in the ED.
There is no experimental aspect to this study, it is only descriptive. Measurement of ETTc pressure is already performed by respiratory therapy/respiratory care. We simply seek to assess these measurements to determine if any patients in fact have high ETTc pressure. If it is found that patients do have ETTc with high pressures, this might allow emergency department staff or prehospital personnel such as paramedics or EMTs to use this information to seek methods by which endotracheal intubation can be improved and patients can be intubated without excessive ETTc pressure.
This is a pilot study. We have conducted several in vitro studies, which have all demonstrated that paramedics, EMTs, and emergency department physicians practice endotracheal intubation in a method that might result in excessively inflated ETTc.
- Conditions
- Intubation, Intratracheal
- Keywords
- endotracheal, intubation, tracheal, pressure, cufflator
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2010 (estimated)
- Study startOct 2005
- Primary completionSep 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation, IntratrachealStudies 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
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Hoffman, MD, Principal investigator, Beth Israel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01252173
- Sponsor's protocol ID
- 120-05
- Status last verified
- Apr 2015
- First submitted
- 1 Dec 2010
- Last updated
- 21 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MEASUREMENT OF ENDOTRACHEAL TUBE CUFF PRESSURE IN EMERGENCY DEPARTMENT PATIENTS
- ClinicalTrials.gov ID
- NCT01252173
- Acronym / sponsor ID
- 120-05
- Conditions
- Intubation, Intratracheal
- Keywords
- endotracheal, intubation, tracheal, pressure, cufflator
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Beth Israel Medical CenterUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 2 Dec 2010 (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.
The purpose of this research is to measure the endotracheal tube cuff pressure in patients who have been endotracheally intubated emergently in the emergency department or in the field by prehospital personnel. Overinflation of ETTc pressure is associated with injury, and we seek to determine if the phenomenon of excessively inflated ETTc can be detected in endotracheally intubated patients in the ED.
There is no experimental aspect to this study, it is only descriptive. Measurement of ETTc pressure is already performed by respiratory therapy/respiratory care. We simply seek to assess these measurements to determine if any patients in fact have high ETTc pressure. If it is found that patients do have ETTc with high pressures, this might allow emergency department staff or prehospital personnel such as paramedics or EMTs to use this information to seek methods by which endotracheal intubation can be improved and patients can be intubated without excessive ETTc pressure.
This is a pilot study. We have conducted several in vitro studies, which have all demonstrated that paramedics, EMTs, and emergency department physicians practice endotracheal intubation in a method that might result in excessively inflated ETTc.
Study design
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All emergency department patients, and all patients admitted from the ED
Key inclusion criteria (1 listed)
- Patient emergently endotracheally intubated with a cuffed endotracheal tube.
Key exclusion criteria (2 listed)
- Endotracheal intubation procedure performed in a setting other than the prehospital (field) or emergency department of participating institution. This specifically excludes endotracheally intubated patients transferred from another hospital, chronic care facility, or other location.
- Non-emergent or elective endotracheal intubation.
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
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2015.
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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.
Robert Hoffman, MD principal investigator
Beth Israel Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Intubation, Intratracheal, run by Beth Israel Medical Center.
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 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: withdrawn, as of the sponsor's last update on 21 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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 21 Apr 2015.