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

NCT04378192 | Completed

• 1 other identifier: LMA obesity
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Bariatric Surgery Candidate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• View of the glottis

  During the action of intubation after induction of anaesthesia

• Number of attempts required for intubation,

  During the action of intubation after induction of anaesthesia

• Anaesthetist's satisfaction score

  During the action of intubation after induction of anaesthesia

• Intubation difficulty score (IDS)

  During the action of intubation after induction of anaesthesia

• Need for external pressure during intubation

  During the action of intubation after induction of anaesthesia

Study Arms (2)

Face mask ventilation

ACTIVE COMPARATOR

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

Laryngeal mask ventilation

ACTIVE COMPARATOR

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

Interventions

Laryngeal mask airway DEVICE

Insertion of laryngeal mask airway before intubation of a morbidly obese patient

Also known as: LMA

Laryngeal mask ventilation

face mask DEVICE

use of face mask before intubation of a morbidly obese patient

Face mask ventilation

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Suez Canal University

Ismailia, Egypt

Location

MeSH Terms

Interventions

Laryngeal Masks; Masks

Intervention Hierarchy (Ancestors)

Intubation, Intratracheal; Airway Management; Therapeutics; Intubation; Investigative Techniques; Protective Devices; Equipment and Supplies; Personal Protective Equipment; Manufactured Materials; Technology, Industry, and Agriculture; Surgical Attire; Equipment and Supplies, Hospital; Surgical Equipment

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia and intensive care

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 7, 2020
• Study Start: February 1, 2019
• Primary Completion: August 30, 2019
• Study Completion: January 30, 2020
• Last Updated: May 8, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)