Randomized Comparative Study Between Classic Laryngeal Mask Airway and I Gel Airway in Obese Patients Having BMI 35-40 During Elective Non Abdominal Surgery.

NCT03843827 | Completed DMC

• 1 other identifier: N 34-2017/Ms
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Invistigators study both supraglottic airway devices; the classic LMA and the I GEL mask are satisfactory devices providing high airway leaking pressures. Although both devices provide high airway leaking pressures, Invistigators study revealed that the I gel mask provides a better seal with the glottic aperture and shorter time of insertion than cLMA. Both devices showed also effective ventilation, more hemodynamic stability and no episode of hypoxia with minimal post-operative complications.

Conditions

LMA Vs I Gel

Outcome Measures

Primary Outcomes (1)

• Time of insertion of each device .

  Invistigators study Time of insertion of each device,Laryngeal Mask Airway and I gel

  Half an hour

Secondary Outcomes (6)

• Leaking pressure of each device.

  Half an hour

• Confirmation of position by fiber optic

  Half an hour

• Blood Pressure

  24 hours

• Heart Rate

  24 hours

• Oxygen saturation

  24 hours

Study Arms (2)

Group A (LMA Group)

ACTIVE COMPARATOR

Active Comparator: Group A (LMA Group) LMA-Classic™ laryngeal mask airway (Classic™LMA) by Dr. Archie Brain into clinical practice in 1988 brought about a revolution in anesthesia. In the literature, there are over 2,500 studies supporting Classic™ LMA usage. Following the success and popularity of Classic™ LMA, many different variants of this device have been designed and marketed,trying to offer a simple and effective alternative to the endotracheal intubation.

Device: Laryngeal Mask Airway

Group B (I gel Group)

ACTIVE COMPARATOR

I gel is a new type of laryngeal mask and doesn't have an inflatable cuff. Because of its thermoplastic elastomer structure, it exactly adapts to the supraglottic tissue by binding with body temperature,thus minimising air leakage

Device: I gel Airway

Interventions

Laryngeal Mask Airway DEVICE

The aim of this study is to compare between cLMA and I gel regarding insertion success rate, the time of insertion, leaking pressure, assessment of position by fiber optic, hemodynamic, Spo2 for each device during insertion and maintenance of general anaesthesia and postoperative complications in obese patients

Group A (LMA Group)

I gel Airway DEVICE

I gel is a new type of laryngeal mask and doesn't have an inflatable cuff. Because of its thermoplastic elastomer structure, it exactly adapts to the supraglottic tissue by binding with body temperature, thus minimising air leakage

Group B (I gel Group)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adult healthy ASA II patients
• both genders
• BMI 35-40
• aged 18 - 60 years
• Mallampati grade I, II with airway score \< 4 according to El Ganzouri score during elective non abdominal surgery ≤ 2hour e.g diagnostic arthroscopy, hysteroscopy and cataract

You may not qualify if:

• ASA class III or IV
• Age \>60 years or \<18 years,
• people with hypertension, diabetes, pregnancy, gastro oesophageal reflux disease, cardiovascular ,renal disease4. difficult mask ventilation , obstructive sleep apnea ,any position rather than supine , airway score ≥ 4 according to El Ganzouri score
• \. any form of sore throat ,patients allergic to any drugs used in the study 6. PCV mode if measured tidal volume was lesser than 6 ml/kg it will be excluded.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Ahmed Abdalla Mohamed

Cairo, 11451, Egypt

Location

MeSH Terms

Interventions

Laryngeal Masks

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 50Patients are randomly divided by computer designed lists and then concealed in closed envelopes into 2 equal groups: 1. Group A (n = 25), in which classic LMA is used for ventilation. 2. Group B (n = 25), in which I gel is used for ventilation.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesia &I.C.U and Pain Clinic, Cairo University

Model Details: Investigators hypothesize that both supraglottic devices, the classic LMA and i gel are effective in ventilation of obese patient.

Study Record Dates

• First Submitted: February 8, 2019
• First Posted: February 18, 2019
• Study Start: March 9, 2019
• Primary Completion: May 15, 2019
• Study Completion: May 18, 2019
• Last Updated: May 21, 2019

Record last verified: 2019-05

Locations

EG (1)