Endotracheal Intubation Risk AssessmentNCT01037374
Anticipation of the Difficult Airway: the Preoperative Airway Assessment Form
A study testing Preoperative assessment form in people with Endotracheal Intubation Risk Assessment, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to see if our experimental preoperative airway assessment form is a better indicator of difficult airway as compared to the anesthesia record that is presently used. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endotracheal Intubation Risk Assessment
- What is being tested?
- Preoperative assessment form
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Dec 2012
- Phase
- Interventional
- 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
Who may be able to join
- CA-1, CA-2, and CA-3 anesthesiology residents starting from July 2008-July 2010
Who cannot join
- the same anesthesiology residents who are working with patients 17 and younger, patients who are already intubated, and patients undergoing emergent surgery.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Hermann Hospital, Medical Center
Houston, Texas, 77030
About this study
Official title: Anticipation of the Difficult Airway: the Preoperative Airway Assessment Form as an Educational and Quality Improvement Tool
The purpose of this study is to see if our experimental preoperative airway assessment form is a better indicator of difficult airway as compared to the anesthesia record that is presently used.
Read the detailed description
Predicting difficult airway continues to be problematic for even the most seasoned of anesthesiologists. In our study, the resident class will be our sample population. The residents will be randomly assigned into two groups: the experimental group will be utilizing the new preoperative airway assessment form and the control group will be utilizing the standard anesthesia record. Simultaneously, a subset of our anesthesia experts will also be assessing patients preoperatively. The five areas of difficult airway management will be considered: difficult mask ventilation, difficult supraglottic airway, difficult laryngoscopy, difficult intubation, and difficult surgical airway.
According to the American Society of Anesthesiologists, the incidence of intubation has remained stable throughout the 1980s and 1990s despite attempts to predict its occurrence. Many of these cases were considered to be preventable; therefore, a better prediction of and preparation for difficult airway management may lead to a reduction in adverse events.
- Conditions
- Endotracheal Intubation Risk Assessment
- Being tested
- Preoperative assessment form
- Keywords
- risk, assessment, difficult, endotracheal, intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative assessment formOther
(based on the american society of anesthesiologists)components of the form include: neck measurements; neck mobility; mallampati; wilson's test; pre-existing conditions; and predictions of difficult mask ventilation, supraglottic airway, laryngoscopy, intubation, and surgical airway.
| Study group | Role | What they receive |
|---|---|---|
| Difficult Airway Assessment Form | Experimental | Not described Receives: Other: Preoperative assessment form |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of an experimental preoperative assessment form by residents will result in more complete documentation of important airway features compared to use of the current forms
Measured: interim analysis will be assessed after 1 year
Secondary outcomes (5)
use of the experimental preoperative assessment form will result in greater resident recognition of patients at high risk for a difficult airway as judged independently by one of 3 senior faculty investigators.
Measured: interim analyses will be assessed after 1 year
the percentage of patients intubated using an awake method will be greater among residents using the new form than those using the current form
Measured: interim analysis will be assessed after 1 year
the percentage of patients requiring multiple intubation attempts or use of invasive airway techniques will be lower among residents using the new form.
Measured: interim analysis will be assessed after 1 year
spontaneous knowledge of important airway features will be more complete among residents using the new form at 18 months of training.
Measured: interim analysis will be assessed after 1 year
observations made during this study will allow refinement of the new form to augment the identification of patients with difficult airway.
Measured: interim analysis will be assessed after 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2009 (estimated)
- Study startAug 2008
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endotracheal Intubation Risk AssessmentStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Anesthesia Education and Research
- Responsible party
- Principal investigator, Carin A. Hagberg, The University of Texas Health Science Center, Houston
- Investigators
- Carin A Hagberg, MD, Principal investigator, University of Texas at Houston Health Science Center, Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01037374
- Sponsor's protocol ID
- 07-0144
- Status last verified
- Sep 2014
- First submitted
- 21 Dec 2009
- Last updated
- 25 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anticipation of the Difficult Airway: the Preoperative Airway Assessment Form as an Educational and Quality Improvement Tool
- ClinicalTrials.gov ID
- NCT01037374
- Acronym / sponsor ID
- 07-0144
- Conditions
- Endotracheal Intubation Risk Assessment
- Keywords
- risk, assessment, difficult, endotracheal, intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Foundation for Anesthesia Education and Research
- Study start
- Aug 2008
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 23 Dec 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.
The purpose of this study is to see if our experimental preoperative airway assessment form is a better indicator of difficult airway as compared to the anesthesia record that is presently used.
Detailed description
Predicting difficult airway continues to be problematic for even the most seasoned of anesthesiologists. In our study, the resident class will be our sample population. The residents will be randomly assigned into two groups: the experimental group will be utilizing the new preoperative airway assessment form and the control group will be utilizing the standard anesthesia record. Simultaneously, a subset of our anesthesia experts will also be assessing patients preoperatively. The five areas of difficult airway management will be considered: difficult mask ventilation, difficult supraglottic airway, difficult laryngoscopy, difficult intubation, and difficult surgical airway.
According to the American Society of Anesthesiologists, the incidence of intubation has remained stable throughout the 1980s and 1990s despite attempts to predict its occurrence. Many of these cases were considered to be preventable; therefore, a better prediction of and preparation for difficult airway management may lead to a reduction in adverse events.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Difficult Airway Assessment Form | Experimental | Other: Preoperative assessment form |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- CA-1, CA-2, and CA-3 anesthesiology residents starting from July 2008-July 2010
Key exclusion criteria (1 listed)
- the same anesthesiology residents who are working with patients 17 and younger, patients who are already intubated, and patients undergoing emergent surgery.
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 |
|---|---|---|
| Preoperative assessment form(based on the american society of anesthesiologists)components of the form include: neck measurements; neck mobility; mallampati; wilson's test; pre-existing conditions; and predictions of difficult mask ventilation, supraglottic airway, laryngoscopy, intubation, and surgical airway. | Other | Difficult Airway Assessment Form |
Primary outcome
Use of an experimental preoperative assessment form by residents will result in more complete documentation of important airway features compared to use of the current forms
Time frame: interim analysis will be assessed after 1 year
5 secondary outcomes
use of the experimental preoperative assessment form will result in greater resident recognition of patients at high risk for a difficult airway as judged independently by one of 3 senior faculty investigators.
Time frame: interim analyses will be assessed after 1 year
the percentage of patients intubated using an awake method will be greater among residents using the new form than those using the current form
Time frame: interim analysis will be assessed after 1 year
the percentage of patients requiring multiple intubation attempts or use of invasive airway techniques will be lower among residents using the new form.
Time frame: interim analysis will be assessed after 1 year
spontaneous knowledge of important airway features will be more complete among residents using the new form at 18 months of training.
Time frame: interim analysis will be assessed after 1 year
observations made during this study will allow refinement of the new form to augment the identification of patients with difficult airway.
Time frame: interim analysis will be assessed after 1 year
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 25 Sep 2014.
Related trials for Endotracheal Intubation Risk Assessment
Not yet recruitingObservational study
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Ultrasonography, Airway Management
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.
Carin A Hagberg, MD principal investigator
University of Texas at Houston Health Science Center, Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative assessment form in people with Endotracheal Intubation Risk Assessment, run by The University of Texas Health Science Center, Houston 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 1 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 25 Sep 2014. 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?
Use of an experimental preoperative assessment form by residents will result in more complete documentation of important airway features compared to use of the current forms (time frame: interim analysis will be assessed after 1 year). 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 25 Sep 2014.