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

NCT03841890 | Completed

• 1 other identifier: 201601025A3C502
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Intubation, Intratracheal; Laryngoscopes; Anesthesia, General

Outcome Measures

Primary Outcomes (2)

• The first attempt success rate

  After intubation immediately

• Intubation time

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

  After intubation immediately

Secondary Outcomes (4)

• Blood pressure

  1 minute and 5 minutes after intubation

• Heart rate

  1 minute and 5 minutes after intubation

• Sore throat

  On postoperative day 1

• Mucosal injury

  On postoperative day 1

Study Arms (3)

Intubation with the Clarus Video System as a video stylet

EXPERIMENTAL

Device: the Clarus Video System as a video stylet

Intubation with the Clarus Video System as a lightwand

EXPERIMENTAL

Device: the Clarus Video System as a lightwand

Intubation with direct laryngoscope

ACTIVE COMPARATOR

Device: direct laryngoscope

Interventions

the Clarus Video System as a video stylet DEVICE

video-guided intubation

Also known as: Trachway as a video stylet

Intubation with the Clarus Video System as a video stylet

the Clarus Video System as a lightwand 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.

Also known as: Trachway as a lightwand

Intubation with the Clarus Video System as a lightwand

direct laryngoscope DEVICE

Macintosh laryngoscope size 3

Intubation with direct laryngoscope

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, Taiwan

Location

Related Publications (13)

• 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.

  PMID: 26578526 BACKGROUND

• 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.

  PMID: 30347104 BACKGROUND

• 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.

  PMID: 26917599 BACKGROUND

• 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.

  PMID: 9349075 BACKGROUND

• 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.

  PMID: 15681945 BACKGROUND

• 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.

  PMID: 26821697 BACKGROUND

• 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.

  PMID: 18378968 BACKGROUND

• 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.

  PMID: 7661351 BACKGROUND

• 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.

  PMID: 25593618 BACKGROUND

• 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.

  PMID: 23975566 BACKGROUND

• 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.

  PMID: 24044439 BACKGROUND

• 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.

  PMID: 11176090 BACKGROUND

• 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.

  PMID: 30832590 DERIVED

Study Officials

• An-Hsun Cho, PhD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Sore throat and mucosa injury are documented by a blinded observer on the next day.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: February 15, 2019
• Study Start: November 4, 2016
• Primary Completion: April 13, 2018
• Study Completion: April 14, 2018
• Last Updated: February 15, 2019

Record last verified: 2016-11

Locations

TW (1)