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Completed

NCT Number: NCT04378192

Laryngeal Mask Airway as a Bridge for Intubation of Obese Patients for 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.

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Key information

Conditions

Bariatric Surgery Candidate

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Suez Canal University

Ismailia, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laryngeal mask airway

Device

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

Other names: LMA

face mask

Device

use of face mask before intubation of a morbidly obese patient

Primary outcomes

  1. Time to intubation TTI

    Time frame: During the action of intubation after induction of anaesthesia

    The time starts with insertion of glidescop and ends at its withdrawal

Secondary outcomes

  1. View of the glottis

    Time frame: 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

  2. Number of attempts required for intubation,

    Time frame: 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

  3. Anaesthetist's satisfaction score

    Time frame: During the action of intubation after induction of anaesthesia

    On a scale rang from 0 representing totally dissatisfied to 10 representing fully satisfied

  4. Intubation difficulty score (IDS)

    Time frame: 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.

  5. Need for external pressure during intubation

    Time frame: During the action of intubation after induction of anaesthesia

    to direct the larynx downward to facilitate endotracheal intubation

Sponsors and collaborators

Lead sponsor

Suez Canal University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
May 7, 2020
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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