NCT01725828

Brief Summary

Routine surgery requires artificial breathing through the placement of a plastic tube into the patient's windpipe via mouth or nose. This tube serves as the source of providing oxygen to the patients during surgery. Difficulties during insertion of this tube may lead to serious complications and during this life-threatening crisis the only way to provide oxygen to the patient is by the help of a procedure called cricothyrotomy (CTY). CTY is a life saving procedure that involves an incision on the patient neck at a very precise location called Cricothyroid Membrane (CTM). The current method of identifying this location is by palpation of neck cartilages by the operator. The incorrect identification of the CTM could lead to many complications. In certain patients such as obese or distorted neck features the identification of CTM would be difficult. Ultrasound (US) has improved the success rate of many anesthesia procedures .Its use has been described for identification of neck structures; however, this technique of localization has not been validated against the gold standard which is the use of CT scan. The purpose of our study is to determine the precision of identifying the CTM using the US versus the conventional finger palpation when compared to the gold standard.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
223

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 9, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 14, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

April 19, 2018

Status Verified

April 1, 2018

Enrollment Period

1.7 years

First QC Date

November 9, 2012

Last Update Submit

April 17, 2018

Conditions

Difficult Breathing

Keywords

Cricothyroid membraneUltrasoundNeck landmarksExternal palpation

Outcome Measures

Primary Outcomes (1)

  • accuracy in identification of the Cricothyroid Membrane

    accuracy in identification of the CM which was measured by a digital ruler in millimeter from the CT-point to the US-point or EP-point. We defined success as the proportion of accurate attempts within 5 mm distance from the CT-point to the US-point or EP-point.

    Less than 1 min

Study Arms (2)

External Palpation group

EXPERIMENTAL

External Palpation group will consist of 109 patients, who's CTM will be marked using traditional palpation technique of identifying the Cricothyroid membrane.

Other: External Palpation

Ultrasound group

EXPERIMENTAL

Ultrasound group will consist of 114 patients, who's CTM will be marked using, ultrasonography to identify the CTM. The Intervention by using the Ultrasound to determine the CTM.

Device: Ultrasound

Interventions

UltrasoundDEVICE

Using the Ultrasound to determine the location of the CTM.

Also known as: Ultrasonography
Ultrasound group
External PalpationOTHER

Using External Palpation to identify cricothyoid membrane

Also known as: Digital Palpation
External Palpation group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA physical status I-III patients aged ≥ 18 with neck pathology who were scheduled for a neck CT scan at University Health Network. All patients recruited in the study had neck pathologies including previous neck surgery, irradiation and/or neck mass.

You may not qualify if:

  • patients who were unable to lie flat, unable to maintain a neutral neck position and those who refused to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UHN

Toronto, Ontario, M5G 2C4, Canada

Location

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (18)

  • Caplan RA, Posner KL, Ward RJ, Cheney FW. Adverse respiratory events in anesthesia: a closed claims analysis. Anesthesiology. 1990 May;72(5):828-33. doi: 10.1097/00000542-199005000-00010.

    PMID: 2339799RESULT

  • Domino KB, Posner KL, Caplan RA, Cheney FW. Airway injury during anesthesia: a closed claims analysis. Anesthesiology. 1999 Dec;91(6):1703-11. doi: 10.1097/00000542-199912000-00023.

    PMID: 10598613RESULT

  • American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Practice guidelines for management of the difficult airway: an updated report by the American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Anesthesiology. 2003 May;98(5):1269-77. doi: 10.1097/00000542-200305000-00032. No abstract available.

    PMID: 12717151RESULT

  • Segal R. A response to 'Difficult Airway Society guidelines for management of the unanticipated difficult intubation', Henderson JJ, Popat MT, Latto IP and Pearce AC, Anaesthesia 2004; 59: 675-94. Anaesthesia. 2004 Nov;59(11):1150-1. doi: 10.1111/j.1365-2044.2004.04005.x. No abstract available.

    PMID: 15479346RESULT

  • Mori M, Fujimoto J, Iwasaka H, Noguchi T. Emergency percutaneous dilatational cricothyroidotomy after failed intubation. Anaesth Intensive Care. 2002 Feb;30(1):101-2. No abstract available.

    PMID: 11939430RESULT

  • Griggs WM, Myburgh JA, Worthley LI. Urgent airway access--an indication for percutaneous tracheostomy? Anaesth Intensive Care. 1991 Nov;19(4):586-7. doi: 10.1177/0310057X9101900421. No abstract available.

    PMID: 1750647RESULT

  • Goldmann K, Braun U. Airway management practices at German university and university-affiliated teaching hospitals--equipment, techniques and training: results of a nationwide survey. Acta Anaesthesiol Scand. 2006 Mar;50(3):298-305. doi: 10.1111/j.1399-6576.2006.00853.x.

    PMID: 16480462RESULT

  • Wong DT, Lai K, Chung FF, Ho RY. Cannot intubate-cannot ventilate and difficult intubation strategies: results of a Canadian national survey. Anesth Analg. 2005 May;100(5):1439-1446. doi: 10.1213/01.ANE.0000148695.37190.34.

    PMID: 15845702RESULT

  • Bair AE, Panacek EA, Wisner DH, Bales R, Sakles JC. Cricothyrotomy: a 5-year experience at one institution. J Emerg Med. 2003 Feb;24(2):151-6. doi: 10.1016/s0736-4679(02)00715-1.

    PMID: 12609644RESULT

  • McGill J, Clinton JE, Ruiz E. Cricothyrotomy in the emergency department. Ann Emerg Med. 1982 Jul;11(7):361-4. doi: 10.1016/s0196-0644(82)80362-4.

    PMID: 7091796RESULT

  • Hsiao J, Pacheco-Fowler V. Videos in clinical medicine. Cricothyroidotomy. N Engl J Med. 2008 May 29;358(22):e25. doi: 10.1056/NEJMvcm0706755. No abstract available.

    PMID: 18509116RESULT

  • Kumar A, Chuan A. Ultrasound guided vascular access: efficacy and safety. Best Pract Res Clin Anaesthesiol. 2009 Sep;23(3):299-311. doi: 10.1016/j.bpa.2009.02.006.

    PMID: 19862889RESULT

  • Levin PD, Sheinin O, Gozal Y. Use of ultrasound guidance in the insertion of radial artery catheters. Crit Care Med. 2003 Feb;31(2):481-4. doi: 10.1097/01.CCM.0000050452.17304.2F.

    PMID: 12576955RESULT

  • Warman P, Nicholls B. Ultrasound-guided nerve blocks: efficacy and safety. Best Pract Res Clin Anaesthesiol. 2009 Sep;23(3):313-26. doi: 10.1016/j.bpa.2009.02.004.

    PMID: 19862890RESULT

  • Erkan M, Tolu I, Aslan T, Guney E. Ultrasonography in laryngeal cancers. J Laryngol Otol. 1993 Jan;107(1):65-8. doi: 10.1017/s0022215100122182.

    PMID: 8445322RESULT

  • Sustic A, Zupan Z, Antoncic I. Ultrasound-guided percutaneous dilatational tracheostomy with laryngeal mask airway control in a morbidly obese patient. J Clin Anesth. 2004 Mar;16(2):121-3. doi: 10.1016/j.jclinane.2003.04.005.

    PMID: 15110374RESULT

  • Muhammad JK, Patton DW, Evans RM, Major E. Percutaneous dilatational tracheostomy under ultrasound guidance. Br J Oral Maxillofac Surg. 1999 Aug;37(4):309-11. doi: 10.1054/bjom.1999.0072.

    PMID: 10475654RESULT

  • Nicholls SE, Sweeney TW, Ferre RM, Strout TD. Bedside sonography by emergency physicians for the rapid identification of landmarks relevant to cricothyrotomy. Am J Emerg Med. 2008 Oct;26(8):852-6. doi: 10.1016/j.ajem.2007.11.022.

    PMID: 18926340RESULT

Related Links

MeSH Terms

Conditions

Dyspnea

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Naveed Siddiqui, MD, MSc

    Samuel Lunenfeld Research Institute, Mount Sinai Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 9, 2012

First Posted

November 14, 2012

Study Start

October 1, 2012

Primary Completion

June 1, 2014

Study Completion

July 1, 2014

Last Updated

April 19, 2018

Record last verified: 2018-04

Locations

CA(2)