Laryngeal Mask Supreme and I-Gel in Edentulate Geriatric Patients

Airway Morbidity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03760679
• Other study ID #: 341-SBKAEK
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: December 1, 2024

Study information

• Verified date: March 2022
• Source: Dokuz Eylul University
• Contact: Sule Özbilgin
• Phone: 05055252901
• Email: ozbilginsule[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: December 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Airway Morbidity

Intervention

Device:
• Laryngeal mask Supreme evaluation
Device: Laryngeal mask Supreme evaluation
• i-gel evaluation
Device: i-gel evaluation

Locations

Country	Name	City	State
Turkey	Sule Özbilgin	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Airway Seal Pressure Values		intraoperative
Primary	insertion time	placement of airway device (second)	intraoperative
Secondary	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
Secondary	dysphagia	postoperative pharyngolaryngeal morbidity- dysphagia (yes/no)	postoperative 1th hour and 24th hour
Secondary	dysphonia	postoperative pharyngolaryngeal morbidity- dysphonia (yes/no)	postoperative 1th hour and 24th hour