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: November 16, 2011

Last verified: November 2011

History of Changes

Purpose

Inability to provide oxygen to the patient remains the most fearful anesthesia-related mishap. Cricothyrotomy 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. Several patient populations, including morbidly obese, short neck, radiation to and previous neck surgeries, have difficult landmarks for this procedure. Ultrasound 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. The study will focus on developing a reliable technique for the sonographic identification of the cricoid membrane. The ultrasound guided technique will be compared to standard digital palpation of the cricothyroid membrane to evaluate the performance of the procedure, in human cadavers.

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

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

Primary 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.

Secondary Outcome Measures:

Success/ Failure rate [ Time Frame: less than 5 minutes from starting of procedure ] [ Designated as safety issue: Yes ]
Successful insertion/ failure will be defined as insertion of the device in the anatomically correct position in less than 5 minutes of starting of the procedure.

Complications will include tracheal and laryngeal injuries during the insertion cadaver will be visually inspected for correct positioning after each attempt.
Complication [ Time Frame: less than 5 minutes ] [ Designated as safety issue: Yes ]
Complications will include tracheal and laryngeal injuries during the insertion cadaver will be visually inspected for correct positioning after each attempt.

Enrollment:	47
Study Start Date:	April 2011
Study Completion Date:	September 2011
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)

Time of insertion measured in seconds

Total number of attempts

Difficulty to manually identify the cricothyroid membrane measured on a 4 point scale

Complications that include laryngeal or tracheal injuries will be observed using a fiberoptic bronchoscope (inserted in the larynx before and after each procedure), analyzed after the procedure by the three anesthesiologists, and then anatomically confirmed after dissection performed by an anatomist while the device is kept in situ.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

First phase 10 cadavers with difficult and impossible landmarks and 2 performers

Second Phase - Comparison of efficacy:

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

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
Last Updated:	November 16, 2011
Health Authority:	Canada: Ethics Review Committee

ClinicalTrials.gov processed this record on June 17, 2013

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