GlideScope With EGRI Assessment in Obese Patients

NCT ID: NCT02188979

Last Updated: 2014-07-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 195 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2014-04-30

Brief Summary

BACKGROUND Unpredicted difficult tracheal intubation (DTI) with Macintosh laryngoscopy occurs frequently in obese patients. We investigated the incidence of DTI using the GlideScope® videolaryngoscope (GVL) with an algorithm based on a pre-operative assessment with the El Ganzouri Risk Index (EGRI).

METHODS We prospectively enrolled morbidly obese patients (BMI>40 kg/m2) undergoing abdominal surgery. Patients were scheduled for flexible fibre optic bronchoscopic intubation (FFBI) or GVL intubation if the EGRI score was ≥7 or <7, respectively. The primary outcome was the occurrence of DTI that was defined as Cormack and Lehane (C&L) grades ≥III, Intubation Difficulty Scale (IDS)>5 and modified IDS (mIDS)>5. A numeric rating scale (NRS) was also used. Secondary outcomes included intubation success during the first attempt, the time to Cormack (TTC), the time to intubation (TTI), failure to intubate, oxygen desaturation and difficult ventilation.

Detailed Description

The EGRI, a multivariate risk index that combines seven variables associated with DTI, was evaluated in all patients during the pre-anaesthesia visit. The results were reported in the clinical chart. All tracheal intubations in obese patients needing surgery were routinely performed using GVL. The intubations were performed or assisted by five board-certified anaesthesiologists who had prior experience with at least 20 GVL intubations, as well as at least two years of experience with anaesthesia in obese patients. In cases where the GVL intubation was performed by anaesthesiologists that were in training, the GVL expert was actively advising the operator during all of the intubating procedures. The standard equipment included a GVL with blade number three to five and an orotracheal hockey stick tube with a malleable single-use stylet (Fr 14, Intubating Stylet, DEAS). The standard anaesthesia induction started with 3-5 minutes of pre-oxygenation using 5 cm H2O PEEP in a 30° head-up position, as well as induction with fentanyl 3 μg kg -1 (LBW), propofol 2-3 mg kg -1 (LBW) and suxamethonium 1 mg Kg -1 (TBW). When spontaneous respiration ceased, the patient was mask ventilated with 100% oxygen. The tube was lubricated and advanced into the mouth under direct visual guidance to avoid complications, and then, under indirect visual guidance using the GVL monitor. The correct placement of the cuffed tube was verified using a capnograph and a stethoscope. The tube sizes were 7.0 for women and 7.5 for men. Each patient was monitored using an electrocardiogram, non-invasive arterial blood pressure measurement, and pulse oximetry before both tracheal intubation and anaesthesia induction. The basic demographic data and airway characteristics necessary to evaluate the primary outcome and to calculate the EGRI score were registered prior to anaesthesia. Patients with an EGRI score of 7 or higher were scheduled for elective fibre optic flexible bronchoscopic intubation (FFBI), while patients with an EGRI score of less than 7 underwent anaesthesia induction and GVL intubation, according to a predefined algorithm

Conditions

Morbid Obesity

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Body Mass Index (BMI)>40 kg m-2.
• Surgery with tracheal intubation scheduled

Exclusion Criteria

• age < 18 years
• severe psychological disorders that have the possibility of limiting the patient's comprehension of information
• previously impossible mask ventilation or intubation with GVL
• presence of pharyngo-laryngeal or neck tumours

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Università degli Studi di Brescia

OTHER

Sponsor Role: lead

Responsible Party

Elena Cagnazzi

Medical Doctor Anesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alessandro Mosca, MD

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi di Brescia

Elena Cagnazzi, MD

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi di Brescia

Federico Pe, MD

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi di Brescia

Tiziana Togazzari, MD

Role: STUDY_CHAIR

Universitry of Brescia

Ottavia Manenti, MD

Role: STUDY_CHAIR

Univertsity of Brescia

Francesco Mittempergher, MD

Role: STUDY_CHAIR

Università degli Studi di Brescia

Elena Raffetti, MD

Role: STUDY_CHAIR

Università degli Studi di Brescia

Francesco Donato, Professor

Role: STUDY_CHAIR

Università degli Studi di Brescia

Nicola Latronico, Professor

Role: STUDY_DIRECTOR

Università degli Studi di Brescia

Locations

Department of Anaesthesia, Critical Care Medicine and Emergency University of Brescia at Spedali Civili.

Brescia, Brescia, Italy

Countries

Italy

References

Padwal RS, Klarenbach SW, Wang X, Sharma AM, Karmali S, Birch DW, Majumdar SR. A simple prediction rule for all-cause mortality in a cohort eligible for bariatric surgery. JAMA Surg. 2013 Dec;148(12):1109-15. doi: 10.1001/jamasurg.2013.3953.

Reference Type: BACKGROUND

PMID: 24132685 (View on PubMed)

Buchwald H, Oien DM. Metabolic/bariatric surgery Worldwide 2008. Obes Surg. 2009 Dec;19(12):1605-11. doi: 10.1007/s11695-009-0014-5.

Reference Type: BACKGROUND

PMID: 19885707 (View on PubMed)

Nicholson A, Smith AF, Lewis SR, Cook TM. Tracheal intubation with a flexible intubation scope versus other intubation techniques for obese patients requiring general anaesthesia. Cochrane Database Syst Rev. 2014 Jan 17;2014(1):CD010320. doi: 10.1002/14651858.CD010320.pub2.

Reference Type: BACKGROUND

PMID: 24443105 (View on PubMed)

Cook TM, MacDougall-Davis SR. Complications and failure of airway management. Br J Anaesth. 2012 Dec;109 Suppl 1:i68-i85. doi: 10.1093/bja/aes393.

Reference Type: BACKGROUND

PMID: 23242753 (View on PubMed)

Juvin P, Lavaut E, Dupont H, Lefevre P, Demetriou M, Dumoulin JL, Desmonts JM. Difficult tracheal intubation is more common in obese than in lean patients. Anesth Analg. 2003 Aug;97(2):595-600. doi: 10.1213/01.ANE.0000072547.75928.B0.

Reference Type: BACKGROUND

PMID: 12873960 (View on PubMed)

Kim WH, Ahn HJ, Lee CJ, Shin BS, Ko JS, Choi SJ, Ryu SA. Neck circumference to thyromental distance ratio: a new predictor of difficult intubation in obese patients. Br J Anaesth. 2011 May;106(5):743-8. doi: 10.1093/bja/aer024. Epub 2011 Feb 24.

Reference Type: BACKGROUND

PMID: 21354999 (View on PubMed)

Serocki G, Neumann T, Scharf E, Dorges V, Cavus E. Indirect videolaryngoscopy with C-MAC D-Blade and GlideScope: a randomized, controlled comparison in patients with suspected difficult airways. Minerva Anestesiol. 2013 Feb;79(2):121-9. Epub 2012 Oct 2.

Reference Type: BACKGROUND

PMID: 23032922 (View on PubMed)

Cortellazzi P, Minati L, Falcone C, Lamperti M, Caldiroli D. Predictive value of the El-Ganzouri multivariate risk index for difficult tracheal intubation: a comparison of Glidescope videolaryngoscopy and conventional Macintosh laryngoscopy. Br J Anaesth. 2007 Dec;99(6):906-11. doi: 10.1093/bja/aem297. Epub 2007 Oct 25.

Reference Type: BACKGROUND

PMID: 17962241 (View on PubMed)

el-Ganzouri AR, McCarthy RJ, Tuman KJ, Tanck EN, Ivankovich AD. Preoperative airway assessment: predictive value of a multivariate risk index. Anesth Analg. 1996 Jun;82(6):1197-204. doi: 10.1097/00000539-199606000-00017.

Reference Type: BACKGROUND

PMID: 8638791 (View on PubMed)

Caldiroli D, Cortellazzi P. A new difficult airway management algorithm based upon the El Ganzouri Risk Index and GlideScope(R) videolaryngoscope. A new look for intubation? Minerva Anestesiol. 2011 Oct;77(10):1011-7. Epub 2011 May 24.

Reference Type: BACKGROUND

PMID: 21610665 (View on PubMed)

Cooper RM, Pacey JA, Bishop MJ, McCluskey SA. Early clinical experience with a new videolaryngoscope (GlideScope) in 728 patients. Can J Anaesth. 2005 Feb;52(2):191-8. doi: 10.1007/BF03027728.

Reference Type: BACKGROUND

PMID: 15684262 (View on PubMed)

Maassen R, Lee R, Hermans B, Marcus M, van Zundert A. A comparison of three videolaryngoscopes: the Macintosh laryngoscope blade reduces, but does not replace, routine stylet use for intubation in morbidly obese patients. Anesth Analg. 2009 Nov;109(5):1560-5. doi: 10.1213/ANE.0b013e3181b7303a. Epub 2009 Aug 27.

Reference Type: BACKGROUND

PMID: 19713258 (View on PubMed)

Serocki G, Bein B, Scholz J, Dorges V. Management of the predicted difficult airway: a comparison of conventional blade laryngoscopy with video-assisted blade laryngoscopy and the GlideScope. Eur J Anaesthesiol. 2010 Jan;27(1):24-30. doi: 10.1097/EJA.0b013e32832d328d.

Reference Type: BACKGROUND

PMID: 19809328 (View on PubMed)

Andersen LH, Rovsing L, Olsen KS. GlideScope videolaryngoscope vs. Macintosh direct laryngoscope for intubation of morbidly obese patients: a randomized trial. Acta Anaesthesiol Scand. 2011 Oct;55(9):1090-7. doi: 10.1111/j.1399-6576.2011.02498.x. Epub 2011 Sep 8.

Reference Type: BACKGROUND

PMID: 22092206 (View on PubMed)

Xue FS, Li CW, Zhang GH, Li XY, Sun HT, Liu KP, Liu J, Wang X. GlideScope-assisted awake fibreoptic intubation: initial experience in 13 patients. Anaesthesia. 2006 Oct;61(10):1014-5. doi: 10.1111/j.1365-2044.2006.04809.x. No abstract available.

Reference Type: BACKGROUND

PMID: 16978330 (View on PubMed)

Ydemann M, Rovsing L, Lindekaer AL, Olsen KS. Intubation of the morbidly obese patient: GlideScope((R)) vs. Fastrach. Acta Anaesthesiol Scand. 2012 Jul;56(6):755-61. doi: 10.1111/j.1399-6576.2012.02693.x. Epub 2012 Apr 23.

Reference Type: BACKGROUND

PMID: 22524487 (View on PubMed)

DeMaria EJ. Bariatric surgery for morbid obesity. N Engl J Med. 2007 May 24;356(21):2176-83. doi: 10.1056/NEJMct067019. No abstract available.

Reference Type: BACKGROUND

PMID: 17522401 (View on PubMed)

Ogden CL, Carroll MD, Curtin LR, McDowell MA, Tabak CJ, Flegal KM. Prevalence of overweight and obesity in the United States, 1999-2004. JAMA. 2006 Apr 5;295(13):1549-55. doi: 10.1001/jama.295.13.1549.

Reference Type: BACKGROUND

PMID: 16595758 (View on PubMed)

Adnet F, Borron SW, Racine SX, Clemessy JL, Fournier JL, Plaisance P, Lapandry C. The intubation difficulty scale (IDS): proposal and evaluation of a new score characterizing the complexity of endotracheal intubation. Anesthesiology. 1997 Dec;87(6):1290-7. doi: 10.1097/00000542-199712000-00005.

Reference Type: BACKGROUND

PMID: 9416711 (View on PubMed)

Han R, Tremper KK, Kheterpal S, O'Reilly M. Grading scale for mask ventilation. Anesthesiology. 2004 Jul;101(1):267. doi: 10.1097/00000542-200407000-00059. No abstract available.

Reference Type: BACKGROUND

PMID: 15220820 (View on PubMed)

Sun DA, Warriner CB, Parsons DG, Klein R, Umedaly HS, Moult M. The GlideScope Video Laryngoscope: randomized clinical trial in 200 patients. Br J Anaesth. 2005 Mar;94(3):381-4. doi: 10.1093/bja/aei041. Epub 2004 Nov 26.

Reference Type: BACKGROUND

PMID: 15567809 (View on PubMed)

Aziz MF, Healy D, Kheterpal S, Fu RF, Dillman D, Brambrink AM. Routine clinical practice effectiveness of the Glidescope in difficult airway management: an analysis of 2,004 Glidescope intubations, complications, and failures from two institutions. Anesthesiology. 2011 Jan;114(1):34-41. doi: 10.1097/ALN.0b013e3182023eb7.

Reference Type: BACKGROUND

PMID: 21150569 (View on PubMed)

Caldiroli D, Molteni F, Sommariva A, Frittoli S, Guanziroli E, Cortellazzi P, Orena EF. Upper limb muscular activity and perceived workload during laryngoscopy: comparison of Glidescope(R) and Macintosh laryngoscopy in manikin: an observational study. Br J Anaesth. 2014 Mar;112(3):563-9. doi: 10.1093/bja/aet347. Epub 2013 Oct 22.

Reference Type: BACKGROUND

PMID: 24148322 (View on PubMed)

Other Identifiers

GLOBE

Identifier Type: -

Identifier Source: org_study_id