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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cricothyrotomy using Digital Palpation | Active Comparator | Group-1 will perform Cricothyrotomy using conventional digital palpation technique |
|
| Ultrasound guided cricothyrotomy group | Experimental | Group-2 Ultrasound guided cricothyrotomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Utrasound guided cricothyrotomy | Procedure | Utrasound guided cricothyrotomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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)). | On avergae less than 300 seconds |
| Measure | Description | Time Frame |
|---|---|---|
| Insertion Time | Defined as palpation of the skin to completion of procedure- cannula in trachea. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Naveed Siddiqui, MD | Mount Sinai Hospital Department of Anesthesia and Pain Management | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cricothyrotomy Using Digital Palpation | Group-1 will perform cricothyrotomy using conventional digital palpation technique The identification of the cricothyroid membrane by digital palpation was performed by using the index and third fingers of the non-dominant hand. The thyroid cartilage was first palpated in the midline starting from cephalad and moving caudally until the cricoid cartilage is palpated. The is the space between the inferior border of the thyroid cartilage and the superior border of the cricoid cartilage |
| FG001 | Ultrasound Guided Cricothyrotomy Group | Group-2 Ultrasound guided cricothyrotomy A 15-10 mHz linear probe (MicroMaxx system, Sonosite Canada Inc, Markham, Ontario, Canada) was used to obtain sonographic images of anatomical landmarks on cadaveric necks as described by Kristensen. The participants held the linear high-frequency transducer in their non-dominant hand and placed themselves on the right side of the cadaver facing towards the head of the cadaver. Then they placed the US probe transversely over the cadaver's neck just above the suprasternal notch in order to visualize the trachea. The transducer was then moved laterally to the patient's right side until the right border of the transducer was superficial to the midline of the trachea. During this movement it was ensured that the right end of the transducer was kept in the midline of the trachea while the left end of the transducer was rotated into the sagittal plane resulting in a longitudinal scan of the midline of the trachea. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Characteristics of participants and human cadavers
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| ID | Title | Description |
|---|---|---|
| BG000 | Cricothyrotomy Using Digital Palpation | Group-1 will perform Cricothyrotomy using conventional digital palpation technique Utrasound guided cricothyrotomy: Utrasound guided cricothyrotomy |
| BG001 | Ultrasound Guided Cricothyrotomy Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Insertion Time | Defined as palpation of the skin to completion of procedure- cannula in trachea. | Posted | Mean | Standard Deviation | seconds | less than 5 minutes from starting of procedure |
|
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Serious and other non serious adverse events were not collected
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cricothyrotomy Using Digital Palpation | Group-1 will perform cricothyrotomy using conventional digital palpation technique The identification of the cricothyroid membrane by digital palpation was performed by using the index and third fingers of the non-dominant hand. The thyroid cartilage was first palpated in the midline starting from cephalad and moving caudally until the cricoid cartilage is palpated. The is the space between the inferior border of the thyroid cartilage and the superior border of the cricoid cartilage |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Naveed Siddiqui | Department of Anesthesia and Pain Management, Mount Sinai Hospital Toronto, Canada | 4165864800 | 5270 | naveed.siddiqui@uhn.ca |
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| not more than 300 seconds |
| Correct Landmarking | Correct landmarking by all participants between the ultrasound and digital palpation group | less than 300 seconds |
Group-2 Ultrasound guided cricothyrotomy Utrasound guided cricothyrotomy: Utrasound guided cricothyrotomy |
| BG002 | Total | Total of all reporting groups |
|
| Sex: Female, Male | Gender description is for Cadvaers only | Count of Participants | Participants |
|
| Neck circumference | Mean | Standard Deviation | Centimeters |
|
| Landmark grade | Landmark grade indicate the difficulty in identification of anatomical landmarks on the cadavers. Higher grades indicate a greater difficulty in identification | Number | participants |
|
| Years post graduate trainee level | Number | Participants |
|
Group-2 Ultrasound guided cricothyrotomy A 15-10 mHz linear probe (MicroMaxx system, Sonosite Canada Inc, Markham, Ontario, Canada) was used to obtain sonographic images of anatomical landmarks on cadaveric necks as described by Kristensen. The participants held the linear high-frequency transducer in their non-dominant hand and placed themselves on the right side of the cadaver facing towards the head of the cadaver. Then they placed the US probe transversely over the cadaver's neck just above the suprasternal notch in order to visualize the trachea. The transducer was then moved laterally to the patient's right side until the right border of the transducer was superficial to the midline of the trachea. During this movement it was ensured that the right end of the transducer was kept in the midline of the trachea while the left end of the transducer was rotated into the sagittal plane resulting in a longitudinal scan of the midline of the trachea. |
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|
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| Primary | 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)). | Posted | Number | Participants | On avergae less than 300 seconds |
|
|
|
|
| Secondary | Number of Attempts | Number of attempts were defined as an actual attempt to cannulate trachea or layrnx of the cadavers by the participants. | Posted | Number | participants | not more than 300 seconds |
|
|
|
|
| Secondary | Correct Landmarking | Correct landmarking by all participants between the ultrasound and digital palpation group | Posted | Number | participants | less than 300 seconds |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Ultrasound Guided Cricothyrotomy Group | Group-2 Ultrasound guided cricothyrotomy A 15-10 mHz linear probe (MicroMaxx system, Sonosite Canada Inc, Markham, Ontario, Canada) was used to obtain sonographic images of anatomical landmarks on cadaveric necks as described by Kristensen. The participants held the linear high-frequency transducer in their non-dominant hand and placed themselves on the right side of the cadaver facing towards the head of the cadaver. Then they placed the US probe transversely over the cadaver's neck just above the suprasternal notch in order to visualize the trachea. The transducer was then moved laterally to the patient's right side until the right border of the transducer was superficial to the midline of the trachea. During this movement it was ensured that the right end of the transducer was kept in the midline of the trachea while the left end of the transducer was rotated into the sagittal plane resulting in a longitudinal scan of the midline of the trachea. | 0 | 0 | 0 | 0 |
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| None -Mild Grade 3-4(n=12,15) |
|
| Moderate-severe Grade 3-4(n=12,15) |
|
| Fisher Exact |
| <0.001 |
| 2-Sided |
| No |
| Superiority or Other |
| Yes ( Grade3-4) |
|
| No ( Grade3-4) |
|