GlideScope With EGRI Assessment in Obese Patients (GLOBE)

July 10, 2014 updated by: Elena Cagnazzi, Università degli Studi di Brescia

GlideScope Videolaryngoscopy and Pre-Operative Assessment of El-Ganzouri Risk Index for Tracheal Intubation in Morbidly Obese Patients The Prospective Observational GLOBE Study

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.

Study Overview

Status

Completed

Conditions

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

Study Type

Observational

Enrollment (Actual)

195

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Brescia, Italy, 25100
        • Department of Anaesthesia, Critical Care Medicine and Emergency University of Brescia at Spedali Civili.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Ten minutes after the intubation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Ten minutes after the intubation
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.
Ten minutes after the intubation
intubation failures
Time Frame: Ten minutes after the intubation failure
Failure to intubate was defined as when tracheal intubation proved impossible after three attempts
Ten minutes after the intubation failure
difficult mask ventilation
Time Frame: Ten minutes after the intubation
Difficult ventilation was defined with the use of the Han scale
Ten minutes after the intubation
oxygen desaturation
Time Frame: Ten minutes after the intubation
Oxygen desaturation was defined as an oxygen saturation of less than 90%
Ten minutes after the intubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università degli Studi di Brescia

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

July 6, 2014

First Submitted That Met QC Criteria

July 10, 2014

First Posted (Estimate)

July 14, 2014

Study Record Updates

Last Update Posted (Estimate)

July 14, 2014

Last Update Submitted That Met QC Criteria

July 10, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GLOBE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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