Laryngeal Mask Airway as a Bridge for Intubation of Obese Patients for Sleeve Gastrectomy

Assessment of the Use of Laryngeal Mask Airway as Abridge for Intubation of Morbidly Obese Patients Undergoing Sleeve Gastrectomy

Ventilation, as well as intubation of a morbidly obese patient, is challenging and require special preparations and skilful hands, in this study laryngeal mask airway insertion is used as a bridge for intubation to facilitate ventilation as give enough time to anaesthetics and muscle relaxants to work on.

Study Overview

• Status: Completed
• Conditions: Bariatric Surgery Candidate
• Intervention / Treatment: Device: face mask; Device: Laryngeal mask airway

Detailed Description

The ordinary pathway of intubating a morbidly obese patient for sleeve gastrectomy is bordered by the risk of difficult ventilation and intubation with the subsequent events of hypoxia and hypoventilation. When the patient is easy ventilated, it gives some sort of confidence and pleasure for the anaesthetist that the way of intubation will not be so hard.

One problem here is the difficulty of ventilating a morbidly obese patient, in this study the investigators used laryngeal mask airway as a bridge before inserting the endotracheal tube

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Ismailia, Egypt
    • Suez Canal University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Morbid obese patient BMI>40
• ASA I, II, III
• Elective sleeve gastrectomy

Exclusion Criteria:

• Oral cavity infection or pathological abnormalities
• Suspected or known abnormalities in supraglottic anatomy
• Patients planned for awake fiberoptic intubation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Face mask ventilation; Use of face mask ventilation technique after induction of anaesthesia and administration pf muscle relaxant till the insertion of the endotracheal tube in a morbidly obese patient undergoing sleeve gastrectomy	Device: face mask; use of face mask before intubation of a morbidly obese patient
ACTIVE_COMPARATOR: Laryngeal mask ventilation; Use of laryngeal mask airway LMA for ventilation after induction of anaesthesia and administration pf muscle relaxant till the insertion of the endotracheal tube in a morbidly obese patient undergoing sleeve gastrectomy	Device: Laryngeal mask airway; Insertion of laryngeal mask airway before intubation of a morbidly obese patient; Other Names: LMA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to intubation TTI	The time starts with insertion of glidescop and ends at its withdrawal	During the action of intubation after induction of anaesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
View of the glottis	Based on the percentage of glottic opening (POGO) score as well as Cormack and Lehane's (C&L) classification	During the action of intubation after induction of anaesthesia
Number of attempts required for intubation,	How many times the anaesthetist needs to try to succeed in insertion of the endotracheal tube	During the action of intubation after induction of anaesthesia
Anaesthetist's satisfaction score	On a scale rang from 0 representing totally dissatisfied to 10 representing fully satisfied	During the action of intubation after induction of anaesthesia
Intubation difficulty score (IDS)	Intubation difficulty score (IDS) is the sum of seven variables, each presents 1 point, score 0 represents easy intubation, score 1 to 5 represents moderate difficulty and score more than 5 was considered difficult intubation.	During the action of intubation after induction of anaesthesia
Need for external pressure during intubation	to direct the larynx downward to facilitate endotracheal intubation	During the action of intubation after induction of anaesthesia

Collaborators and Investigators

• Sponsor: Suez Canal University

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2019
• Primary Completion (ACTUAL): August 30, 2019
• Study Completion (ACTUAL): January 30, 2020

Study Registration Dates

• First Submitted: May 4, 2020
• First Submitted That Met QC Criteria: May 6, 2020
• First Posted (ACTUAL): May 7, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 8, 2020
• Last Update Submitted That Met QC Criteria: May 6, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: LMA obesity

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No