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Difficult BreathingNCT01725828

Accuracy of Ultrasound in Identification of Cricothyroid Membrane: A Randomized Clinical Trial

A study testing Ultrasound and External Palpation in people with Difficult Breathing, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Difficult Breathing
What is being tested?
Ultrasound and External Palpation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
223 participants
Where
2 sitesCanada
Study dates
Oct 2012to Jul 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Canada2 sites
  • UHN

    Toronto, Ontario, M5G 2C4

  • University Health Network

    Toronto, Ontario, M5G 2C4

Other trials in Canada

About this study

Official title: Ultrasound is Superior to Conventional Palpation Method in Identification of the Cricothyroid Membrane in Subjects With Poorly Defined Neck Landmarks: A Randomized Clinical Trial

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.

Read the detailed description

Inability to secure the airway remains the most frequent cause of anesthesia-related mishaps.Difficult airway management continues to be the major challenge in anesthesia as it is responsible for a third of anesthesia-related claims and is the single largest class of closed claim injury suits. Difficulties in tracheal intubation is the most frequent cause of anesthesia-related morbidity and mortality.

Repeated attempts of tracheal intubations can result in serious soft tissue injury and rapidly deteriorate into a life threatening "cannot intubate-cannot ventilate" (CICV) crisis. The guidelines suggested by the American Society of Anesthesiologists and the Difficult Airway Society for managing the unanticipated difficult airway recommend the performance of a cricothyrotomy(CTY) as the next step for a CICV scenario.

Cricothyrotomy is an infrequently performed life saving procedure when facing a difficult CICV airway.Previous studies quote, the incidence of the CICV scenario to be in the range of 0.01-2 per 10,000 cases. It is therefore imperative that anesthesiologists have the necessary knowledge and skills in successfully managing this life-threatening airway crisis. However, several studies demonstrated that many practicing anesthesiologists and anesthesia trainees (residents/fellows) are uncomfortable with the management of a CICV situation because it is such a rare event. A recent Canadian survey shows that only a quarter of the residents and 40% of practicing anesthesiologists were comfortable with performing a cricothyrotomy. Similar findings were reported in a German national survey of academic teaching hospitals where difficult airway situations, particularly a CICV crisis, were poorly managed and were postulated to have contributed to adverse patient outcomes.Complications of emergency CTY by physicians are common, with rates ranging from 9% to 40%.These complications include failure to cannulate the trachea, false airway passage, severe bleeding, posterior tracheal wall injuries, pneumothorax and esophageal laceration. All of these major complications may be related to improper identification of anatomical landmarks used to identify the correct position of cricothyroid membrane (CTM). The current method of CTY relies solely on digital palpation of these landmarks to accurately identify the CTM.

Several studies have identified independent predictors for patients with difficult airway. These include characteristics such as high body mass index, presence of beard, short bull neck, distorted neck anatomy either due to congenital or acquired pathology such as goiters or radiation to the neck. These are the same factors which may lead to improper identification of neck landmarks for the CTY.

The outcome and accuracy of CTY may be improved with better preparedness and pre-procedural identification of the neck landmarks for CTY before deciding the method of anesthetic. This is especially true in patients with anatomical features of difficult airway, who may be the ones more likely to have a difficult airway or require an emergency CT. In this patient population, incorrect localization of the CTM may lead to significant airway morbidity or failure to quickly establish an airway.

The role of ultrasound in airway management:

Bedside ultrasound is increasingly being used to assist anesthesiologists in performing various procedures.The use of ultrasonography (US) has been shown to significantly reduce complications and improve outcomes. Diagnostic application of US for upper airway anatomy and its role for the performance of CTY and bedside tracheostomy has been previously described. However, little is known on the reliability and validity of the US when compared to the gold standard CT scan in identifying the CTM.

The methods used to identify CTM are based on identification of anatomical landmarks and digital palpation. This may be difficult in patients with poorly defined anatomy, the very same population in which the likelihood of a difficult intubation/emergency surgical airway are higher.

The trachea and paratracheal soft tissues of the neck can be examined at the highest resolution with US probes of high frequency due to their superficial position. The anterior tracheal wall, thyroid and cricoid cartilages, tracheal rings, and pre-tracheal tissue may all be well visualized , which allows the clinician to select the optimal space for CTY tube placement. The use of US for assisting with airway management in anesthesia and in the intensive care unit is directly related to the availability of low-cost and portable US capabilities. Clinicians initially described US-guided central venous catheterization, followed by US-guided regional anesthesia techniques. Recently, a few studies examined the role of US for emergency airway procedures. Nichollas et al developed a standardized US technique to identify the CTM. The findings in this study suggest that the CTM and relevant structures can be quickly identified by emergency physicians using US technique. However this study was limited to patients with normal airway and mainly focused to the standardization of technique. it did not validate the technique against a gold standard. In another study Muhammad et al, reported four cases in which ultrasound was successfully used to perform percutaneous tracheostomy in the ICU. Cricothyroid membrane can easily be located on CT scan.

In summary, inability to secure the airway remains the most frequent cause of anesthesia-related morbidity and mortality. CTY is highly dependent on proper identification of anatomical land-marks.

Being tested
Ultrasound, External Palpation
Keywords
Cricothyroid membrane, Ultrasound, Neck landmarks, External palpation
Medical subject headings
Dyspnea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UltrasoundDevice

    Also called Ultrasonography

    Using the Ultrasound to determine the location of the CTM.

  • External PalpationOther

    Also called Digital Palpation

    Using External Palpation to identify cricothyoid membrane

Study groups in NCT01725828
Study groupRoleWhat they receive
External Palpation groupExperimentalExternal Palpation group will consist of 109 patients, who's CTM will be marked using traditional palpation technique of identifying the Cricothyroid membrane.
Receives: Other: External Palpation
Ultrasound groupExperimentalUltrasound 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.
Receives: Device: Ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Less than 1 min

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionJun 2014
  4. Study completionJul 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
223 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01725828
Sponsor's protocol ID
1-2012
Status last verified
Apr 2018
First submitted
9 Nov 2012
Last updated
19 Apr 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 2339799
  • 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.

    PubMed 10598613
  • 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.

    PubMed 12717151
  • 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.

    PubMed 15479346
  • 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.

    PubMed 11939430
  • 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.

    PubMed 1750647
  • 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.

    PubMed 16480462
  • 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.

    PubMed 15845702
  • 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.

    PubMed 12609644
  • 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.

    PubMed 7091796
  • 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.

    PubMed 18509116
  • 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.

    PubMed 19862889
  • 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.

    PubMed 12576955
  • 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.

    PubMed 19862890
  • 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.

    PubMed 8445322

Questions about this trial

What is this clinical trial studying?

A study testing Ultrasound and External Palpation in people with Difficult Breathing, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

accuracy in identification of the Cricothyroid Membrane (time frame: Less than 1 min). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01725828, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2018.

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