Trial Outcomes & Findings for Ultrasound Guided Versus Palpation Guided Cricothyrotomy With Poorly Defined Anatomical Landmarks (NCT NCT01475487)
NCT ID: NCT01475487
Last Updated: 2015-06-25
Results Overview
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)).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
47 participants
Primary outcome timeframe
On avergae less than 300 seconds
Results posted on
2015-06-25
Participant Flow
Participant milestones
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
23
|
24
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
had to leave early for personal reasons
|
2
|
1
|
Baseline Characteristics
Ultrasound Guided Versus Palpation Guided Cricothyrotomy With Poorly Defined Anatomical Landmarks
Baseline characteristics by cohort
| Measure |
Cricothyrotomy Using Digital Palpation
n=23 Participants
Group-1 will perform Cricothyrotomy using conventional digital palpation technique
Utrasound guided cricothyrotomy: Utrasound guided cricothyrotomy
|
Ultrasound Guided Cricothyrotomy Group
n=24 Participants
Group-2 Ultrasound guided cricothyrotomy
Utrasound guided cricothyrotomy: Utrasound guided cricothyrotomy
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
NA (NUMBER)
n=5 Participants
|
NA (NUMBER)
n=7 Participants
|
NA (NUMBER)
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Neck circumference
|
21.35 Centimeters
STANDARD_DEVIATION 1.92 • n=5 Participants
|
21.54 Centimeters
STANDARD_DEVIATION 1.74 • n=7 Participants
|
21.45 Centimeters
STANDARD_DEVIATION 1.74 • n=5 Participants
|
|
Landmark grade
Grade-2
|
11 participants
n=5 Participants
|
9 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Landmark grade
Grade-3
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Landmark grade
Grade-4
|
4 participants
n=5 Participants
|
7 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Years post graduate trainee level
POST GRADUATE YEAR-1
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Years post graduate trainee level
POST GRADUATE YEAR-2
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Years post graduate trainee level
POST GRADUATE YEAR-3
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Years post graduate trainee level
POST GRADUATE YEAR-4
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Years post graduate trainee level
POST GRADUATE YEAR-5
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Years post graduate trainee level
FELLOWS
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: On avergae less than 300 secondsThe 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)).
Outcome measures
| Measure |
Cricothyrotomy Using Digital Palpation
n=23 Participants
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
|
Ultrasound Guided Cricothyrotomy Group
n=24 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.
|
|---|---|---|
|
The Primary Outcome Measure Was the Complication Rate Asssed as the Number of Participants Causing Injuries
None - Mild Grade-1-4(n=23,24)
|
6 Participants
|
18 Participants
|
|
The Primary Outcome Measure Was the Complication Rate Asssed as the Number of Participants Causing Injuries
Moderate-severe Grade 1-4(n=23,24)
|
17 Participants
|
6 Participants
|
|
The Primary Outcome Measure Was the Complication Rate Asssed as the Number of Participants Causing Injuries
None -Mild Grade 3-4(n=12,15)
|
0 Participants
|
10 Participants
|
|
The Primary Outcome Measure Was the Complication Rate Asssed as the Number of Participants Causing Injuries
Moderate-severe Grade 3-4(n=12,15)
|
12 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: less than 5 minutes from starting of procedureDefined as palpation of the skin to completion of procedure- cannula in trachea.
Outcome measures
| Measure |
Cricothyrotomy Using Digital Palpation
n=23 Participants
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
|
Ultrasound Guided Cricothyrotomy Group
n=24 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.
|
|---|---|---|
|
Insertion Time
|
110.48 seconds
Standard Deviation 46.94
|
196.13 seconds
Standard Deviation 60.64
|
SECONDARY outcome
Timeframe: not more than 300 secondsNumber of attempts were defined as an actual attempt to cannulate trachea or layrnx of the cadavers by the participants.
Outcome measures
| Measure |
Cricothyrotomy Using Digital Palpation
n=23 Participants
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
|
Ultrasound Guided Cricothyrotomy Group
n=24 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.
|
|---|---|---|
|
Number of Attempts
attempt 2
|
3 participants
|
5 participants
|
|
Number of Attempts
attempt 1
|
20 participants
|
19 participants
|
SECONDARY outcome
Timeframe: less than 300 secondsCorrect landmarking by all participants between the ultrasound and digital palpation group
Outcome measures
| Measure |
Cricothyrotomy Using Digital Palpation
n=23 Participants
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
|
Ultrasound Guided Cricothyrotomy Group
n=24 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.
|
|---|---|---|
|
Correct Landmarking
yes (grade1-4)
|
9 participants
|
15 participants
|
|
Correct Landmarking
no (grade 1-4)
|
14 participants
|
9 participants
|
|
Correct Landmarking
Yes ( Grade3-4)
|
1 participants
|
7 participants
|
|
Correct Landmarking
No ( Grade3-4)
|
11 participants
|
8 participants
|
Adverse Events
Cricothyrotomy Using Digital Palpation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ultrasound Guided Cricothyrotomy Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Naveed Siddiqui
Department of Anesthesia and Pain Management, Mount Sinai Hospital Toronto, Canada
Phone: 4165864800
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place