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Intubation, IntratrachealNCT03841890

The Clarus Video System and Direct Laryngoscope for Rapid Sequence Induction Intubation With Cricoid Pressure

A study testing the Clarus Video System as a video stylet, the Clarus Video System as a lightwand and direct laryngoscope in people with Intubation, Intratracheal and Laryngoscopes, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

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

During an emergency endotracheal intubation, rapid sequence induction intubation with cricoid pressure is frequently implemented to prevent aspiration pneumonia. When properly applied, cricoid pressure may not affect glottic view during endotracheal intubation with either a direct laryngoscope or a video laryngoscope. Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
the Clarus Video System as a video stylet, the Clarus Video System as a lightwand and direct laryngoscope
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteTaiwan
Study dates
4 Nov 2016to 14 Apr 2018
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Older than 20 years of age
  • Scheduled for elective surgery under general anesthesia

Who cannot join

  • BMI (Body Mass Index) > 35 kg/m2
  • Interincisor distance < 3 cm
  • Poor dentition
  • Upper airway tumor
  • Limited neck mobility
  • Pregnancy
  • History of difficult tracheal intubation

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Chang Gung Memorial Hospital

    Taoyuan

Other trials in Taiwan

About this study

Official title: The Clarus Video System (Trachway) and Direct Laryngoscope for Endotracheal Intubation With Cricoid Pressure in Simulated Rapid Sequence Induction Intubation: A Prospective Randomized Controlled Trial

During an emergency endotracheal intubation, rapid sequence induction intubation with cricoid pressure is frequently implemented to prevent aspiration pneumonia. When properly applied, cricoid pressure may not affect glottic view during endotracheal intubation with either a direct laryngoscope or a video laryngoscope. However, the application of cricoid pressure is likely to prolong the intubation time. Limited mouth opening or vulnerable teeth, which often accompany the patients requiring emergency intubation, are the two common factors to deter the intubators from using a laryngoscopic device. Besides, the blade of a laryngoscopic device is often too bulky for a narrow mouth opening, and the blade always bears a level force on upper incisors while the intubator is lifting epiglottis during intubation, which is liable to tooth fracture. In this prospective randomized study, the investigators compare the use of the Clarus Video System and that of direct laryngoscope (Macintosh Laryngoscope) in patients undergoing endotracheal intubation in simulated rapid sequence induction intubation for the primary goals of the first attempt success rate and intubation time.

Being tested
the Clarus Video System as a video stylet, the Clarus Video System as a lightwand, direct laryngoscope

What participants receive

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

  • the Clarus Video System as a video styletDevice

    Also called Trachway as a video stylet

    video-guided intubation

  • the Clarus Video System as a lightwandDevice

    Also called Trachway as a lightwand

    The endotracheal tube will be initially guided into larynx in the dimly lit operating room by a bright glow moving in the anterior soft tissue of the neck and finally by the image of the trachea rings on the video screen.

  • direct laryngoscopeDevice

    Macintosh laryngoscope size 3

Study groups in NCT03841890
Study groupRoleWhat they receive
Intubation with the Clarus Video System as a video styletExperimentalNot described
Receives: Device: the Clarus Video System as a video stylet
Intubation with the Clarus Video System as a lightwandExperimentalNot described
Receives: Device: the Clarus Video System as a lightwand
Intubation with direct laryngoscopeActive comparatorNot described
Receives: Device: direct laryngoscope

What is being measured

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

  1. The first attempt success rate

    Measured: After intubation immediately

  2. Intubation time

    Intubation time was counted from the inserting the device into the patient's mouth to viewing the endotracheal tube into the trachea.

    Measured: After intubation immediately

Secondary outcomes (4)

  1. Blood pressure

    Measure blood pressure in millimeter of mercury by non-invasive blood pressure before induction, 1 minute after intubation, and 5 minutes after intubation

    Measured: 1 minute and 5 minutes after intubation

  2. Heart rate

    Measure heart rate in beats per minute by electrocardiography monitor before induction, 1 minute after intubation, and 5 minutes after intubation

    Measured: 1 minute and 5 minutes after intubation

  3. Sore throat

    Documented by a blinded observer on the next day. Sore throat was graded according to numerical rating scale (NRS): none, NRS = 0; mild, NRS = 1-3; moderate, NRS = 4-6; severe, NRS = 7-10.

    Measured: On postoperative day 1

  4. Mucosal injury

    Documented by a blinded observer on the next day. "Yes" is defined as any oral mucosal lesion reported by participants.

    Measured: On postoperative day 1

Timeline

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

  1. First posted15 Feb 2019
  2. Study start4 Nov 2016
  3. Primary completion13 Apr 2018
  4. Study completion14 Apr 2018

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03841890
Sponsor's protocol ID
201601025A3C502
Status last verified
Nov 2016
First submitted
11 Feb 2019
Last updated
15 Feb 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Algie CM, Mahar RK, Tan HB, Wilson G, Mahar PD, Wasiak J. Effectiveness and risks of cricoid pressure during rapid sequence induction for endotracheal intubation. Cochrane Database Syst Rev. 2015 Nov 18;2015(11):CD011656. doi: 10.1002/14651858.CD011656.pub2.

    PubMed 26578526

  • Birenbaum A, Hajage D, Roche S, Ntouba A, Eurin M, Cuvillon P, Rohn A, Compere V, Benhamou D, Biais M, Menut R, Benachi S, Lenfant F, Riou B; IRIS Investigators Group. Effect of Cricoid Pressure Compared With a Sham Procedure in the Rapid Sequence Induction of Anesthesia: The IRIS Randomized Clinical Trial. JAMA Surg. 2019 Jan 1;154(1):9-17. doi: 10.1001/jamasurg.2018.3577.

    PubMed 30347104

  • Sajayan A, Wicker J, Ungureanu N, Mendonca C, Kimani PK. Current practice of rapid sequence induction of anaesthesia in the UK - a national survey. Br J Anaesth. 2016 Sep;117 Suppl 1:i69-i74. doi: 10.1093/bja/aew017. Epub 2016 Feb 24.

    PubMed 26917599

  • Vanner RG, Clarke P, Moore WJ, Raftery S. The effect of cricoid pressure and neck support on the view at laryngoscopy. Anaesthesia. 1997 Sep;52(9):896-900. doi: 10.1111/j.1365-2044.1997.181-az0315.x.

    PubMed 9349075

  • Turgeon AF, Nicole PC, Trepanier CA, Marcoux S, Lessard MR. Cricoid pressure does not increase the rate of failed intubation by direct laryngoscopy in adults. Anesthesiology. 2005 Feb;102(2):315-9. doi: 10.1097/00000542-200502000-00012.

    PubMed 15681945

  • Komasawa N, Kido H, Miyazaki Y, Tatsumi S, Minami T. Cricoid pressure impedes tracheal intubation with the Pentax-AWS Airwayscope(R): a prospective randomized trial. Br J Anaesth. 2016 Mar;116(3):413-6. doi: 10.1093/bja/aev438. Epub 2016 Jan 27.

    PubMed 26821697

  • Byhahn C, Nemetz S, Breitkreutz R, Zwissler B, Kaufmann M, Meininger D. Brief report: tracheal intubation using the Bonfils intubation fibrescope or direct laryngoscopy for patients with a simulated difficult airway. Can J Anaesth. 2008 Apr;55(4):232-7. doi: 10.1007/BF03021507.

    PubMed 18378968

  • Hung OR, Pytka S, Morris I, Murphy M, Launcelott G, Stevens S, MacKay W, Stewart RD. Clinical trial of a new lightwand device (Trachlight) to intubate the trachea. Anesthesiology. 1995 Sep;83(3):509-14. doi: 10.1097/00000542-199509000-00009.

    PubMed 7661351

  • Cooney DR, Beaudette C, Clemency BM, Tanski C, Wojcik S. Endotracheal intubation with a video-assisted semi-rigid fiberoptic stylet by prehospital providers. Int J Emerg Med. 2014 Nov 26;7(1):45. doi: 10.1186/s12245-014-0045-0. eCollection 2014.

    PubMed 25593618

  • Yang M, Kim JA, Ahn HJ, Choi JW, Kim DK, Cho EA. Double-lumen tube tracheal intubation using a rigid video-stylet: a randomized controlled comparison with the Macintosh laryngoscope. Br J Anaesth. 2013 Dec;111(6):990-5. doi: 10.1093/bja/aet281. Epub 2013 Aug 23.

    PubMed 23975566

  • Hsu HT, Chou SH, Chen CL, Tseng KY, Kuo YW, Chen MK, Cheng KI. Left endobronchial intubation with a double-lumen tube using direct laryngoscopy or the Trachway(R) video stylet. Anaesthesia. 2013 Aug;68(8):851-5. doi: 10.1111/anae.12340.

    PubMed 24044439

  • Hodgson RE, Gopalan PD, Burrows RC, Zuma K. Effect of cricoid pressure on the success of endotracheal intubation with a lightwand. Anesthesiology. 2001 Feb;94(2):259-62. doi: 10.1097/00000542-200102000-00015.

    PubMed 11176090

  • Lin YC, Cho AH, Lin JR, Chung YT. The Clarus Video System (Trachway) and direct laryngoscope for endotracheal intubation with cricoid pressure in simulated rapid sequence induction intubation: a prospective randomized controlled trial. BMC Anesthesiol. 2019 Mar 4;19(1):33. doi: 10.1186/s12871-019-0703-0.

    PubMed 30832590

Questions about this trial

What is this clinical trial studying?

A study testing the Clarus Video System as a video stylet, the Clarus Video System as a lightwand and direct laryngoscope in people with Intubation, Intratracheal and Laryngoscopes, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

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 2 inclusion and 7 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 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. 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?

The first attempt success rate (time frame: After intubation immediately). The study lists 2 primary outcomes in all. 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 NCT03841890, which also lists 13 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 15 Feb 2019.

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