Ultrasound Guided Versus Palpation Guided Cricothyrotomy With Poorly Defined Anatomical Landmarks

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Naveed Siddiqui, Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier:
NCT01475487
First received: November 3, 2011
Last updated: June 24, 2015
Last verified: June 2015
  Purpose

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.


Condition Intervention
Airway Management
Procedure: Utrasound guided cricothyrotomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: A Comparison of Ultrasound Versus Digital Palpation Guided Cricothyrotomy in Subjects With Poorly Defined Anatomical Landmarks

Resource links provided by NLM:


Further study details as provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:

Primary Outcome Measures:
  • The Primary Outcome Measure Was the Complication Rate Asssed as the Number of Participants Causing Injuries [ Time Frame: On avergae less than 300 seconds ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Insertion Time [ Time Frame: less than 5 minutes from starting of procedure ] [ Designated as safety issue: Yes ]
    Defined as palpation of the skin to completion of procedure- cannula in trachea.

  • Number of Attempts [ Time Frame: not more than 300 seconds ] [ Designated as safety issue: No ]
    Number of attempts were defined as an actual attempt to cannulate trachea or layrnx of the cadavers by the participants.

  • Correct Landmarking [ Time Frame: less than 300 seconds ] [ Designated as safety issue: No ]
    Correct landmarking by all participants between the ultrasound and digital palpation group


Enrollment: 47
Study Start Date: April 2011
Study Completion Date: September 2013
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cricothyrotomy using Digital Palpation
Group-1 will perform Cricothyrotomy using conventional digital palpation technique
Procedure: Utrasound guided cricothyrotomy
Utrasound guided cricothyrotomy
Experimental: Ultrasound guided cricothyrotomy group
Group-2 Ultrasound guided cricothyrotomy
Procedure: Utrasound guided cricothyrotomy
Utrasound guided cricothyrotomy

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01475487

Sponsors and Collaborators
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Investigators
Principal Investigator: Naveed Siddiqui, MD Mount Sinai Hospital Department of Anesthesia and Pain Management
  More Information

No publications provided

Responsible Party: Dr. Naveed Siddiqui, Assistant Professor, Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier: NCT01475487     History of Changes
Other Study ID Numbers: CUS-2010
Study First Received: November 3, 2011
Results First Received: June 24, 2015
Last Updated: June 24, 2015
Health Authority: Canada: Ethics Review Committee

ClinicalTrials.gov processed this record on September 02, 2015