Clinical Trials Directory

Trials / Completed

CompletedNCT01475487

Ultrasound Guided Versus Palpation Guided Cricothyrotomy With Poorly Defined Anatomical Landmarks

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
47 (actual)
Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital · Academic / Other
Sex
All
Age
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREUtrasound guided cricothyrotomyUtrasound guided cricothyrotomy

Timeline

Start date
2011-04-01
Primary completion
2011-09-01
Completion
2013-09-01
First posted
2011-11-21
Last updated
2015-06-25
Results posted
2015-06-25

Source: ClinicalTrials.gov record NCT01475487. Inclusion in this directory is not an endorsement.

Ultrasound Guided Versus Palpation Guided Cricothyrotomy With Poorly Defined Anatomical Landmarks (NCT01475487) · Clinical Trials Directory