Laryngeal Mask Supreme and I-Gel in Edentulate Geriatric Patients

Comparison of Laryngeal Mask Supreme and I-Gel in Edentulate Geriatric Patients

The primary aim of this study is to evaluate ease and duration of placing Laryngeal Mask Supreme (LM) and applying I-gel in geriatric patients without teeth. The secondary aim is to compare their effects on ventilation parameters.

Study Overview

• Status: Recruiting
• Conditions: Airway Morbidity
• Intervention / Treatment: Device: Laryngeal mask Supreme evaluation; Device: i-gel evaluation

Detailed Description

Prospective, randomized and double-blind study, aged from 18 to 65 years undergoing elective laparoscopic gynecological surgery.

The patients are randomly assigned to 2 groups:

• Group 1: i-gel
• Group 2: laryngeal mask airway - Supreme

Procedure:

The investigation protocol contains the following sections:

1. Induction of anaesthesia: Preoxygenation will be provided at 6 Liter/min oxygen for three minutes by using a facial mask. After anesthesia induction with fentanyl 1-2 μg/kg and propofol 1-2 mg/kg (12), mask ventilation will be applied with 100% oxygen.
2. Bispectral index values will be held between 40-60.Bispectral index values will be within this interval by increasing or decreasing propofol infusion by 1 mg/kg after additional bolus dose of propofol (1 mg/kg).
3. Insertion of the airway device. The size of the airway device used is based on the manufacturers' recommendations. All devices are deflated a lubricated prior to use. Once inserted, the cuff is be inflated with a manometer up to 60 cm H20 Data recorded: size of airway device, time an number of attempts.
4. Maintenance of anesthesia will be achieved with sevoflurane 1,5-2,5% in a mixture of 50% O2/ 50% nitrogen protoxide. Sevoflurane concentrations will be adjusted to keep bispectral index values at 40-60.
5. Measurement of airway seal pressure (oropharyngeal leak pressure (OLP): at baseline, and two minutes after the airway tool is placed, every 15 minutes until the operation ends and before the airway tool is removed.
6. Ventilatory mechanics and parameters and hemodynamic parameters are measured at baseline, and two minutes after the airway tool is placed, every 15 minutes until the operation ends and before the airway tool is removed.
7. Perioperative complications: Cough, vomiting, laryngeal spasm, laryngeal Stridor
8. Removal of the airway device: Presence of blood - 3 level grading (1:no blood; 2: trace amounts of blood; 3: clear amounts of blood). Complications: sore throat (visual analogue scale :10-point scale), dysphonia (yes/no), dysphagia (yes/no).

• Study Type: Interventional
• Enrollment (Anticipated): 124
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Şule Özbilgin; Phone Number: 05055252901; Email: ozbilginsule@gmail.com
• Study Contact Backup: Name: Sibel Büyükçoban; Email: sibelbuyukcoban@yahoo.com

Study Locations

• Turkey
  • İzmir, Turkey, 35340
    • Recruiting
    • Sule Ozbilgin
    • Contact: Şule Özbilgin; Phone Number: 5055252901; Email: ozbilginsule@gmail.com
    • Principal Investigator: Sibel Büyükçoban, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• American Society of Anesthesiologists Classification I-III patients
• patients aged 65 years and older

Exclusion Criteria:

• having teeth or fixed prosthesis
• having a pathology of the neck or the upper respiratory tract
• having a risk of regurgitation of gastric content/ aspiration (prior upper gastrointestinal system surgery, hiatus hernia, gastrointestinal reflux, history of peptic ulcer and full stomach)
• history or possibility of difficult airway (history of impossible intubation, mallampati score of 3-4, sternomental distance of shorter than 12 cm, thyromental distance of shorter than 6cm, head extension of lower than 90 degrees and mouth opening of lower than 1.5 cm)
• lower pulmonary compliance or higher airway resistance (morbid obesity -BMI>35kg/m2- and pulmonary disease) Each patient will be examined preoperatively and American Society of Anesthesiologists Classification scores and mallampati scores will be recorded. Standard monitoring (ECG, pulse oximetry and noninvasive blood pressure measurement) and bispectral index monitoring will be performed in each patient before induction of anesthesia in the surgical room.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Laryngeal mask Supreme; Device: Laryngeal mask Supreme	Device: Laryngeal mask Supreme evaluation; Device: Laryngeal mask Supreme evaluation; Other Names: Device: Laryngeal mask Supreme evaluation
Experimental: i-gel; Device: i-gel	Device: i-gel evaluation; Device: i-gel evaluation; Other Names: Device: i-gel evaluation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Airway Seal Pressure Values		intraoperative
insertion time	placement of airway device (second)	intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sore throat	postoperative pharyngolaryngeal morbidity- (Visual Analog Pain Scale is a unidimensional measure of pain intensity ), ("no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale])	postoperative 1th hour and 24th hour
dysphagia	postoperative pharyngolaryngeal morbidity- dysphagia (yes/no)	postoperative 1th hour and 24th hour
dysphonia	postoperative pharyngolaryngeal morbidity- dysphonia (yes/no)	postoperative 1th hour and 24th hour

Collaborators and Investigators

• Sponsor: Dokuz Eylul University
• Investigators: Principal Investigator: Sibel Büyükçoban, Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Intensive Care

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: August 30, 2018
• First Submitted That Met QC Criteria: November 29, 2018
• First Posted (Actual): November 30, 2018

Study Record Updates

• Last Update Posted (Actual): March 28, 2022
• Last Update Submitted That Met QC Criteria: March 25, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: geriatric; laryngeal mask; patient
• Additional Relevant MeSH Terms: Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Chlorhexidine
• Other Study ID Numbers: 341-SBKAEK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No