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

Bariatric Surgery Candidate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04378192
• Other study ID #: LMA obesity
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: January 30, 2020

Study information

• Verified date: May 2020
• Source: Suez Canal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 30, 2020
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate

Intervention

Device:
• Laryngeal mask airway
Insertion of laryngeal mask airway before intubation of a morbidly obese patient
• face mask
use of face mask before intubation of a morbidly obese patient

Locations

Country	Name	City	State
Egypt	Suez Canal University	Ismailia

Sponsors (1)

Lead Sponsor	Collaborator
Suez Canal University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Need for external pressure during intubation	to direct the larynx downward to facilitate endotracheal intubation	During the action of intubation after induction of anaesthesia