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GlideScope With EGRI Assessment in Obese Patients (GLOBE)

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ClinicalTrials.gov Identifier: NCT02188979
Recruitment Status : Completed
First Posted : July 14, 2014
Last Update Posted : July 14, 2014
Sponsor:
Information provided by (Responsible Party):
Elena Cagnazzi, Università degli Studi di Brescia

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.


Condition or disease
Morbid Obesity

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

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Study Type : Observational
Actual Enrollment : 195 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: GlideScope Videolaryngoscopy and Pre-Operative Assessment of El-Ganzouri Risk Index for Tracheal Intubation in Morbidly Obese Patients The Prospective Observational GLOBE Study
Study Start Date : March 2012
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014



Primary Outcome Measures :
  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. [ Time Frame: Ten minutes after the intubation ]
    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).


Secondary Outcome Measures :
  1. frequency of tracheal intubation success during the first attempt [ Time Frame: Ten minutes after the intubation ]
    The frequency of intubation success at the first attempt was defined as being when the tracheal intubation was successfully achieved with all the following criteria fulfilled: a single introduction of the laryngoscope and tube progression, C&L I or IIa without external laryngeal displacement, and no need for help by another operator.

  2. the time to Cormack (TTC) and the time to tracheal intubation (TTI). [ Time Frame: Ten minutes after the intubation ]
    TTC was measured from the time the instrument entered patient's mouth until the optimal laryngeal view. TTI was measured from the time the instrument entered the patient's mouth until the tube cuff inflation.

  3. intubation failures [ Time Frame: Ten minutes after the intubation failure ]
    Failure to intubate was defined as when tracheal intubation proved impossible after three attempts

  4. difficult mask ventilation [ Time Frame: Ten minutes after the intubation ]
    Difficult ventilation was defined with the use of the Han scale

  5. oxygen desaturation [ Time Frame: Ten minutes after the intubation ]
    Oxygen desaturation was defined as an oxygen saturation of less than 90%



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability 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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02188979


Locations
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Italy
Department of Anaesthesia, Critical Care Medicine and Emergency University of Brescia at Spedali Civili.
Brescia, Italy, 25100
Sponsors and Collaborators
Università degli Studi di Brescia
Investigators
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Principal Investigator: 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
Study Chair: 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 Director: Nicola Latronico, Professor Università degli Studi di Brescia
Publications:

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Responsible Party: Elena Cagnazzi, Medical Doctor Anesthesiologist, Università degli Studi di Brescia
ClinicalTrials.gov Identifier: NCT02188979    
Other Study ID Numbers: GLOBE
First Posted: July 14, 2014    Key Record Dates
Last Update Posted: July 14, 2014
Last Verified: July 2014
Keywords provided by Elena Cagnazzi, Università degli Studi di Brescia:
airway
equipment - laryngoscopes
intubation - tracheal
obesity.
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms