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

NCT ID: NCT03841890

Last Updated: 2019-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-04

Study Completion Date

2018-04-14

Brief Summary

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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.

Detailed Description

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Conditions

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Intubation, Intratracheal Laryngoscopes Anesthesia, General

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
Sore throat and mucosa injury are documented by a blinded observer on the next day.

Study Groups

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Intubation with the Clarus Video System as a video stylet

Group Type EXPERIMENTAL

the Clarus Video System as a video stylet

Intervention Type DEVICE

video-guided intubation

Intubation with the Clarus Video System as a lightwand

Group Type EXPERIMENTAL

the Clarus Video System as a lightwand

Intervention Type DEVICE

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.

Intubation with direct laryngoscope

Group Type ACTIVE_COMPARATOR

direct laryngoscope

Intervention Type DEVICE

Macintosh laryngoscope size 3

Interventions

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the Clarus Video System as a video stylet

video-guided intubation

Intervention Type DEVICE

the Clarus Video System 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.

Intervention Type DEVICE

direct laryngoscope

Macintosh laryngoscope size 3

Intervention Type DEVICE

Other Intervention Names

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Trachway as a video stylet Trachway as a lightwand

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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An-Hsun Cho, PhD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Locations

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Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type BACKGROUND
PMID: 26578526 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30347104 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26917599 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9349075 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15681945 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26821697 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18378968 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7661351 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25593618 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23975566 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24044439 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11176090 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30832590 (View on PubMed)

Other Identifiers

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201601025A3C502

Identifier Type: -

Identifier Source: org_study_id

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