Airway ManagementNCT01475487
Ultrasound Guided Versus Palpation Guided Cricothyrotomy With Poorly Defined Anatomical Landmarks
A study testing Utrasound guided cricothyrotomy in people with Airway Management, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital.
Trial summary
Inability to provide oxygen to the patient remains the most fearful anesthesia-related mishap. Cricothyrotomy (CT) is an infrequently performed but life saving procedure for an anesthesiologist, who is encountered with this situation. The current method of cricothyrotomy relies on digital palpation (DP). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Airway Management
- What is being tested?
- Utrasound guided cricothyrotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- No sites listed yet
- Study dates
- Apr 2011to Sep 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Residents who are novice to the application of ultrasound in difficult airway scenarios
- Cadavers with difficult and imposible landmarks identification
Who cannot join
- Anethesiologist with previous experience in CT, manual or ultrasound assisted
- Patients with easily identifiable landmarks
About this study
Official title: A Comparison of Ultrasound Versus Digital Palpation Guided Cricothyrotomy in Subjects With Poorly Defined Anatomical Landmarks
Inability to provide oxygen to the patient remains the most fearful anesthesia-related mishap. Cricothyrotomy (CT) is an infrequently performed but life saving procedure for an anesthesiologist, who is encountered with this situation. The current method of cricothyrotomy relies on digital palpation (DP). Several patient populations, including morbidly obese, short neck, radiation to and previous neck surgeries, have difficult landmarks for this procedure. Ultrasound (US) technology has been used in the past to visualize landmarks for cricothyrotomy, but there is no study which has examined the role of ultrasound in patients who have obscure landmarks. There is no data related to the performance of ultrasound guided cricothyrotomy in these patients. In this study, we aimed to determine the outcomes of CT performed on human cadavers using US-guidance, compared to conventional DP, of anatomical landmarks. In particularly, complication rates, failure to cannulate, correct placement of the device and insertion time of CT were assessed.
Read the detailed description
For each cadaver - epidemiological data (age, sex) and morphometric data (Body Mass Index, neck circumference, thyromental distance)
The primary outcome measure was the complication rate as assessed by the severity of injuries; defined as the incidence and severity of posterior laryngeal and tracheal wall injuries, as graded by two anesthesiologists using the grading system described by Murphy et al,( none (no injury); mild (< 5 mm laceration); moderate (> 5mm laceration or partial puncture); severe (> 10 mm laceration or full puncture)). For clinical relevance and analysis of data we dichotomized the scale to none-mild and moderate - severe injuries.
The secondary outcomes include: 1) insertion time, measured in seconds (s) from the time of palpation of the skin to insertion of the Portex device in the trachea; 2) failure, with a 'failure' defined as any attempt in which the trachea was not cannulated, or which required > 300 s to perform; and 3) correct land-marking, defined as having the Portex device inserted via the CM.
- Conditions
- Airway Management
- Being tested
- Utrasound guided cricothyrotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Utrasound guided cricothyrotomyProcedure or surgery
Utrasound guided cricothyrotomy
| Study group | Role | What they receive |
|---|---|---|
| Cricothyrotomy using Digital Palpation | Active comparator | Group-1 will perform Cricothyrotomy using conventional digital palpation technique Receives: Procedure: Utrasound guided cricothyrotomy |
| Ultrasound guided cricothyrotomy group | Experimental | Group-2 Ultrasound guided cricothyrotomy Receives: Procedure: Utrasound guided cricothyrotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Outcome Measure Was the Complication Rate Asssed as the Number of Participants Causing Injuries
The primary outcome measure was the complication rate as assessed by the severity of injuries; defined as the incidence and severity of posterior laryngeal and tracheal wall injuries, as graded by two anesthesiologists using the grading system described by Murphy et al,( none (no injury); mild (< 5 mm laceration); moderate (> 5mm laceration or partial puncture); severe (> 10 mm laceration or full puncture)).
Measured: On avergae less than 300 seconds
Secondary outcomes (3)
Insertion Time
Defined as palpation of the skin to completion of procedure- cannula in trachea.
Measured: less than 5 minutes from starting of procedure
Number of Attempts
Number of attempts were defined as an actual attempt to cannulate trachea or layrnx of the cadavers by the participants.
Measured: not more than 300 seconds
Correct Landmarking
Correct landmarking by all participants between the ultrasound and digital palpation group
Measured: less than 300 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2011 (estimated)
- Study startApr 2011
- Primary completionSep 2011
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Airway ManagementStudies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Naveed Siddiqui, Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Investigators
- Naveed Siddiqui, MD, Principal investigator, Mount Sinai Hospital Department of Anesthesia and Pain Management
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01475487
- Sponsor's protocol ID
- CUS-2010
- Status last verified
- Jun 2015
- First submitted
- 3 Nov 2011
- Last updated
- 25 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Ultrasound Versus Digital Palpation Guided Cricothyrotomy in Subjects With Poorly Defined Anatomical Landmarks
- ClinicalTrials.gov ID
- NCT01475487
- Acronym / sponsor ID
- CUS-2010
- Conditions
- Airway Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 21 Nov 2011 (estimated)
- Results
- Posted 25 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Inability to provide oxygen to the patient remains the most fearful anesthesia-related mishap. Cricothyrotomy (CT) is an infrequently performed but life saving procedure for an anesthesiologist, who is encountered with this situation. The current method of cricothyrotomy relies on digital palpation (DP). Several patient populations, including morbidly obese, short neck, radiation to and previous neck surgeries, have difficult landmarks for this procedure. Ultrasound (US) technology has been used in the past to visualize landmarks for cricothyrotomy, but there is no study which has examined the role of ultrasound in patients who have obscure landmarks. There is no data related to the performance of ultrasound guided cricothyrotomy in these patients. In this study, we aimed to determine the outcomes of CT performed on human cadavers using US-guidance, compared to conventional DP, of anatomical landmarks. In particularly, complication rates, failure to cannulate, correct placement of the device and insertion time of CT were assessed.
Detailed description
For each cadaver - epidemiological data (age, sex) and morphometric data (Body Mass Index, neck circumference, thyromental distance)
The primary outcome measure was the complication rate as assessed by the severity of injuries; defined as the incidence and severity of posterior laryngeal and tracheal wall injuries, as graded by two anesthesiologists using the grading system described by Murphy et al,( none (no injury); mild (< 5 mm laceration); moderate (> 5mm laceration or partial puncture); severe (> 10 mm laceration or full puncture)). For clinical relevance and analysis of data we dichotomized the scale to none-mild and moderate - severe injuries.
The secondary outcomes include: 1) insertion time, measured in seconds (s) from the time of palpation of the skin to insertion of the Portex device in the trachea; 2) failure, with a 'failure' defined as any attempt in which the trachea was not cannulated, or which required > 300 s to perform; and 3) correct land-marking, defined as having the Portex device inserted via the CM.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cricothyrotomy using Digital Palpation | Active comparator | Procedure: Utrasound guided cricothyrotomyGroup-1 will perform Cricothyrotomy using conventional digital palpation technique |
| Ultrasound guided cricothyrotomy group | Experimental | Procedure: Utrasound guided cricothyrotomyGroup-2 Ultrasound guided cricothyrotomy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Residents who are novice to the application of ultrasound in difficult airway scenarios
- Cadavers with difficult and imposible landmarks identification
Key exclusion criteria (2 listed)
- Anethesiologist with previous experience in CT, manual or ultrasound assisted
- Patients with easily identifiable landmarks
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 |
|---|---|---|
| Utrasound guided cricothyrotomyUtrasound guided cricothyrotomy | Procedure or surgery | Cricothyrotomy using Digital Palpation, Ultrasound guided cricothyrotomy group |
Primary outcome
The Primary Outcome Measure Was the Complication Rate Asssed as the Number of Participants Causing Injuries
Time frame: On avergae less than 300 seconds
The primary outcome measure was the complication rate as assessed by the severity of injuries; defined as the incidence and severity of posterior laryngeal and tracheal wall injuries, as graded by two anesthesiologists using the grading system described by Murphy et al,( none (no injury); mild (< 5 mm laceration); moderate (> 5mm laceration or partial puncture); severe (> 10 mm laceration or full puncture)).
3 secondary outcomes
Insertion Time
Time frame: less than 5 minutes from starting of procedure
Number of Attempts
Time frame: not more than 300 seconds
Correct Landmarking
Time frame: less than 300 seconds
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Naveed Siddiqui, MD principal investigator
Mount Sinai Hospital Department of Anesthesia and Pain Management
Questions about this trial
What is this clinical trial studying?
A study testing Utrasound guided cricothyrotomy in people with Airway Management, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital.
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 25 Jun 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?
Yes. Results are posted in the registry (first posted 25 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Primary Outcome Measure Was the Complication Rate Asssed as the Number of Participants Causing Injuries (time frame: On avergae less than 300 seconds). 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 Jun 2015.