NCT02188979

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
195

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 14, 2014

Completed
Last Updated

July 14, 2014

Status Verified

July 1, 2014

Enrollment Period

2.1 years

First QC Date

July 6, 2014

Last Update Submit

July 10, 2014

Conditions

Morbid Obesity

Keywords

airwayequipment - laryngoscopesintubation - trachealobesity.

Outcome Measures

Primary Outcomes (1)

  • 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.

    The primary outcome was the incidence of DTI. Because scores specifically designed to assess DTI with GVL are not available, we used the Cormack and Lehane (C\&L) grades ≥III, the Intubation Difficulty Scale (IDS) \>5 and a modified IDS (mIDS) \>5 to assess DTI. We also conducted a subjective assessment of DTI as rated by the operator on a numeric rating scale (NRS), from 0 (easiest) to 10 (the most difficult procedure).

    Ten minutes after the intubation

Secondary Outcomes (5)

  • frequency of tracheal intubation success during the first attempt

    Ten minutes after the intubation

  • the time to Cormack (TTC) and the time to tracheal intubation (TTI).

    Ten minutes after the intubation

  • intubation failures

    Ten minutes after the intubation failure

  • difficult mask ventilation

    Ten minutes after the intubation

  • oxygen desaturation

    Ten minutes after the intubation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Our patients population is the population of morbidly obese patients scheduled for bariatric surgery or other non-bariatric abdominal surgical interventions and referring to the University Division of Anaesthesia and Intensive Care at Spedali Civili of Brescia.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Brescia, Brescia, 25100, Italy

Location

Related Publications (23)

  • 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.

    PMID: 24132685BACKGROUND

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

    PMID: 19885707BACKGROUND

  • 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.

    PMID: 24443105BACKGROUND

  • 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.

    PMID: 23242753BACKGROUND

  • 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.

    PMID: 12873960BACKGROUND

  • 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.

    PMID: 21354999BACKGROUND

  • 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.

    PMID: 23032922BACKGROUND

  • 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.

    PMID: 17962241BACKGROUND

  • 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.

    PMID: 8638791BACKGROUND

  • 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.

    PMID: 21610665BACKGROUND

  • 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.

    PMID: 15684262BACKGROUND

  • 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.

    PMID: 19713258BACKGROUND

  • 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.

    PMID: 19809328BACKGROUND

  • 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.

    PMID: 22092206BACKGROUND

  • 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.

    PMID: 16978330BACKGROUND

  • 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.

    PMID: 22524487BACKGROUND

  • 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.

    PMID: 17522401BACKGROUND

  • 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.

    PMID: 16595758BACKGROUND

  • 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.

    PMID: 9416711BACKGROUND

  • 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.

    PMID: 15220820BACKGROUND

  • 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.

    PMID: 15567809BACKGROUND

  • 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.

    PMID: 21150569BACKGROUND

  • 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.

    PMID: 24148322BACKGROUND

MeSH Terms

Conditions

Obesity, MorbidObesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Alessandro Mosca, MD

    Università degli Studi di Brescia

    PRINCIPAL INVESTIGATOR

  • Elena Cagnazzi, MD

    Università degli Studi di Brescia

    PRINCIPAL INVESTIGATOR

  • Federico Pe, MD

    Università degli Studi di Brescia

    PRINCIPAL INVESTIGATOR

  • Tiziana Togazzari, MD

    Universitry of Brescia

    STUDY CHAIR

  • Ottavia Manenti, MD

    Univertsity of Brescia

    STUDY CHAIR

  • Francesco Mittempergher, MD

    Università degli Studi di Brescia

    STUDY CHAIR

  • Elena Raffetti, MD

    Università degli Studi di Brescia

    STUDY CHAIR

  • Francesco Donato, Professor

    Università degli Studi di Brescia

    STUDY CHAIR

  • Nicola Latronico, Professor

    Università degli Studi di Brescia

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor Anesthesiologist

Study Record Dates

First Submitted

July 6, 2014

First Posted

July 14, 2014

Study Start

March 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

July 14, 2014

Record last verified: 2014-07

Locations

IT(1)