Airway Management
Conditions
Brief 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). 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.
Interventions
PROCEDUREUtrasound guided cricothyrotomy
Utrasound guided cricothyrotomy
Sponsors
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Residents who are novice to the application of ultrasound in difficult airway scenarios * Cadavers with difficult and imposible landmarks identification
Exclusion criteria
* Anethesiologist with previous experience in CT, manual or ultrasound assisted * Patients with easily identifiable landmarks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Primary Outcome Measure Was the Complication Rate Asssed as the Number of Participants Causing Injuries | 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)). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insertion Time | less than 5 minutes from starting of procedure | Defined as palpation of the skin to completion of procedure- cannula in trachea. |
| Number of Attempts | not more than 300 seconds | Number of attempts were defined as an actual attempt to cannulate trachea or layrnx of the cadavers by the participants. |
| Correct Landmarking | less than 300 seconds | Correct landmarking by all participants between the ultrasound and digital palpation group |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cricothyrotomy Using Digital Palpation Group-1 will perform Cricothyrotomy using conventional digital palpation technique
Utrasound guided cricothyrotomy: Utrasound guided cricothyrotomy | 23 |
| Ultrasound Guided Cricothyrotomy Group Group-2 Ultrasound guided cricothyrotomy
Utrasound guided cricothyrotomy: Utrasound guided cricothyrotomy | 24 |
| Total | 47 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | had to leave early for personal reasons | 2 | 1 |
Baseline characteristics
| Characteristic | Cricothyrotomy Using Digital Palpation | Ultrasound Guided Cricothyrotomy Group | Total |
|---|---|---|---|
| Age, Customized | NA | NA | NA |
| Landmark grade Grade-2 | 11 participants | 9 participants | 20 participants |
| Landmark grade Grade-3 | 8 participants | 8 participants | 16 participants |
| Landmark grade Grade-4 | 4 participants | 7 participants | 11 participants |
| Neck circumference | 21.35 Centimeters STANDARD_DEVIATION 1.92 | 21.54 Centimeters STANDARD_DEVIATION 1.74 | 21.45 Centimeters STANDARD_DEVIATION 1.74 |
| Sex: Female, Male Female | 11 Participants | 17 Participants | 28 Participants |
| Sex: Female, Male Male | 12 Participants | 7 Participants | 19 Participants |
| Years post graduate trainee level FELLOWS | 4 Participants | 4 Participants | 8 Participants |
| Years post graduate trainee level POST GRADUATE YEAR-1 | 4 Participants | 7 Participants | 11 Participants |
| Years post graduate trainee level POST GRADUATE YEAR-2 | 7 Participants | 4 Participants | 11 Participants |
| Years post graduate trainee level POST GRADUATE YEAR-3 | 4 Participants | 2 Participants | 6 Participants |
| Years post graduate trainee level POST GRADUATE YEAR-4 | 2 Participants | 3 Participants | 5 Participants |
| Years post graduate trainee level POST GRADUATE YEAR-5 | 2 Participants | 4 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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)).
Time frame: On avergae less than 300 seconds
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cricothyrotomy Using Digital Palpation | 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 |
| Cricothyrotomy Using Digital Palpation | 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 |
| Cricothyrotomy Using Digital Palpation | 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 |
| Cricothyrotomy Using Digital Palpation | 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 |
| Ultrasound Guided Cricothyrotomy Group | The Primary Outcome Measure Was the Complication Rate Asssed as the Number of Participants Causing Injuries | Moderate-severe Grade 3-4(n=12,15) | 5 Participants |
| Ultrasound Guided Cricothyrotomy Group | The Primary Outcome Measure Was the Complication Rate Asssed as the Number of Participants Causing Injuries | None - Mild Grade-1-4(n=23,24) | 18 Participants |
| Ultrasound Guided Cricothyrotomy Group | The Primary Outcome Measure Was the Complication Rate Asssed as the Number of Participants Causing Injuries | None -Mild Grade 3-4(n=12,15) | 10 Participants |
| Ultrasound Guided Cricothyrotomy Group | The Primary Outcome Measure Was the Complication Rate Asssed as the Number of Participants Causing Injuries | Moderate-severe Grade 1-4(n=23,24) | 6 Participants |
p-value: 0.00195% CI: [1.39, 5.94]Fisher Exact
Comparison: Grade 3-4 comparison of None-mild and moderate-severep-value: <0.001Fisher Exact
Secondary
Correct Landmarking
Correct landmarking by all participants between the ultrasound and digital palpation group
Time frame: less than 300 seconds
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cricothyrotomy Using Digital Palpation | Correct Landmarking | yes (grade1-4) | 9 participants |
| Cricothyrotomy Using Digital Palpation | Correct Landmarking | Yes ( Grade3-4) | 1 participants |
| Cricothyrotomy Using Digital Palpation | Correct Landmarking | no (grade 1-4) | 14 participants |
| Cricothyrotomy Using Digital Palpation | Correct Landmarking | No ( Grade3-4) | 11 participants |
| Ultrasound Guided Cricothyrotomy Group | Correct Landmarking | no (grade 1-4) | 9 participants |
| Ultrasound Guided Cricothyrotomy Group | Correct Landmarking | yes (grade1-4) | 15 participants |
| Ultrasound Guided Cricothyrotomy Group | Correct Landmarking | No ( Grade3-4) | 8 participants |
| Ultrasound Guided Cricothyrotomy Group | Correct Landmarking | Yes ( Grade3-4) | 7 participants |
Comparison: Comparison for Grade 3-4p-value: 0.04395% CI: [0.79, 39.48]Fisher Exact
Secondary
Insertion Time
Defined as palpation of the skin to completion of procedure- cannula in trachea.
Time frame: less than 5 minutes from starting of procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cricothyrotomy Using Digital Palpation | Insertion Time | 110.48 seconds | Standard Deviation 46.94 |
| Ultrasound Guided Cricothyrotomy Group | Insertion Time | 196.13 seconds | Standard Deviation 60.64 |
p-value: <0.01Fisher Exact
Secondary
Number of Attempts
Number of attempts were defined as an actual attempt to cannulate trachea or layrnx of the cadavers by the participants.
Time frame: not more than 300 seconds
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cricothyrotomy Using Digital Palpation | Number of Attempts | attempt 1 | 20 participants |
| Cricothyrotomy Using Digital Palpation | Number of Attempts | attempt 2 | 3 participants |
| Ultrasound Guided Cricothyrotomy Group | Number of Attempts | attempt 1 | 19 participants |
| Ultrasound Guided Cricothyrotomy Group | Number of Attempts | attempt 2 | 5 participants |
p-value: 0.70195% CI: [0.12, 2.72]Fisher Exact