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Completed

NCT Number: NCT01475487

Ultrasound Guided Versus Palpation Guided Cricothyrotomy 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.

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Key information

Conditions

Airway Management

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Utrasound guided cricothyrotomy

Procedure

Utrasound guided cricothyrotomy

Primary outcomes

  1. 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)).

Secondary outcomes

  1. Insertion Time

    Time frame: less than 5 minutes from starting of procedure

    Defined as palpation of the skin to completion of procedure- cannula in trachea.

  2. Number of Attempts

    Time frame: 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.

  3. Correct Landmarking

    Time frame: less than 300 seconds

    Correct landmarking by all participants between the ultrasound and digital palpation group

Sponsors and collaborators

Lead sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Other

Registry information

Official study title

A Comparison of Ultrasound Versus Digital Palpation Guided Cricothyrotomy in Subjects With Poorly Defined Anatomical Landmarks

Important dates

Study start
2011
Primary completion
2011
Study completion
2013
First posted
Nov 21, 2011
Registry last updated
Jun 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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