Ultrasound Guided Versus Palpation Guided Cricothyrotomy With Poorly Defined Anatomical Landmarks

NCT01475487 | Completed Results

• 1 other identifier: CUS-2010
• Study Type: interventional
• Target: 47
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Airway Management

Outcome Measures

Primary Outcomes (1)

• 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)).

  On avergae less than 300 seconds

Secondary Outcomes (3)

• Insertion Time

  less than 5 minutes from starting of procedure

• Number of Attempts

  not more than 300 seconds

• Correct Landmarking

  less than 300 seconds

Study Arms (2)

Cricothyrotomy using Digital Palpation

ACTIVE COMPARATOR

Group-1 will perform Cricothyrotomy using conventional digital palpation technique

Procedure: Utrasound guided cricothyrotomy

Ultrasound guided cricothyrotomy group

EXPERIMENTAL

Group-2 Ultrasound guided cricothyrotomy

Procedure: Utrasound guided cricothyrotomy

Interventions

Utrasound guided cricothyrotomy PROCEDURE

Utrasound guided cricothyrotomy

Cricothyrotomy using Digital Palpation; Ultrasound guided cricothyrotomy group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Residents who are novice to the application of ultrasound in difficult airway scenarios
• Cadavers with difficult and imposible landmarks identification

You may not qualify if:

• Anethesiologist with previous experience in CT, manual or ultrasound assisted
• Patients with easily identifiable landmarks

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead

Results Point of Contact

• Title: Dr Naveed Siddiqui
• Organization: Department of Anesthesia and Pain Management, Mount Sinai Hospital Toronto, Canada

naveed.siddiqui@uhn.ca

4165864800

Study Officials

• Naveed Siddiqui, MD

  Mount Sinai Hospital Department of Anesthesia and Pain Management

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 3, 2011
• First Posted: November 21, 2011
• Study Start: April 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2013
• Last Updated: June 25, 2015
• Results First Posted: June 25, 2015

Record last verified: 2015-06