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

Not Applicable

Completed

• Conditions: Bariatric Surgery Candidate
• Interventions: Device: face mask; Device: Laryngeal mask airway

• Registration Number: NCT04378192
• Lead Sponsor: Suez Canal University

Brief Summary

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.

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 Timeline

• Study Start: 2019-02-01
• Primary Completion: 2019-08-30
• Study Completion: 2020-01-30
• Status Verified: 2020-05
• Study First Submitted: 2020-05-04
• Study First Submitted QC: 2020-05-06
• Last Update Submitted: 2020-05-06
• Study First Posted: 2020-05-07
• Last Update Posted: 2020-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Face mask ventilation	face mask	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
Laryngeal mask ventilation	Laryngeal mask airway	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

Primary Outcome Measures

Name	Time	Method
Time to intubation TTI	During the action of intubation after induction of anaesthesia	The time starts with insertion of glidescop and ends at its withdrawal

Secondary Outcome Measures

Name	Time	Method
View of the glottis	During the action of intubation after induction of anaesthesia	Based on the percentage of glottic opening (POGO) score as well as Cormack and Lehane's (C\&L) classification
Anaesthetist's satisfaction score	During the action of intubation after induction of anaesthesia	On a scale rang from 0 representing totally dissatisfied to 10 representing fully satisfied
Need for external pressure during intubation	During the action of intubation after induction of anaesthesia	to direct the larynx downward to facilitate endotracheal intubation
Number of attempts required for intubation,	During the action of intubation after induction of anaesthesia	How many times the anaesthetist needs to try to succeed in insertion of the endotracheal tube
Intubation difficulty score (IDS)	During the action of intubation after induction of anaesthesia	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.

Trial Locations

Locations (1)

Suez Canal University; 🇪🇬 Ismailia, Egypt