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

Anesthesia, General Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03841890
• Other study ID #: 201601025A3C502
• Status: Completed
• Phase: N/A
• Start date: November 4, 2016
• Est. completion date: April 14, 2018

Study information

• Verified date: November 2016
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: April 14, 2018
• Est. primary completion date: April 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, General
• Intubation, Intratracheal
• Laryngoscopes

Intervention

Device:
• the Clarus Video System as a video stylet
video-guided intubation
• 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.
• direct laryngoscope
Macintosh laryngoscope size 3

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (12)

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;(11):CD011656. doi: 10.1002/14651858.CD011656.pub2. Review. — View Citation

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. Effect of Cricoid Pressure Compared With a Sham Procedure in the Rapid Sequence Induction of Anesthesia: The IRIS Randomized Clinical Trial. JAMA Surg. 2018 Oct 17. doi: 10.1001/jamasurg.2018.3577. [Epub ahead of print] — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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® video stylet. Anaesthesia. 2013 Aug;68(8):851-5. doi: 10.1111/anae.12340. — View Citation

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. — View Citation

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

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. — View Citation

Turgeon AF, Nicole PC, Trépanier 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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The first attempt success rate		After intubation immediately
Primary	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	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	1 minute and 5 minutes after intubation
Secondary	Heart rate	Measure heart rate in beats per minute by electrocardiography monitor before induction, 1 minute after intubation, and 5 minutes after intubation	1 minute and 5 minutes after intubation
Secondary	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.	On postoperative day 1
Secondary	Mucosal injury	Documented by a blinded observer on the next day. "Yes" is defined as any oral mucosal lesion reported by participants.	On postoperative day 1