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Laryngeal Mask Supreme and I-Gel in Edentulate Geriatric Patients

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ClinicalTrials.gov Identifier: NCT03760679
Recruitment Status : Recruiting
First Posted : November 30, 2018
Last Update Posted : August 19, 2020
Sponsor:
Information provided by (Responsible Party):
Sule Ozbilgin, Dokuz Eylul University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Airway Morbidity Device: Laryngeal mask Supreme evaluation Device: i-gel evaluation Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Laryngeal Mask Supreme and I-Gel in Edentulate Geriatric Patients
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : December 1, 2022
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Laryngeal mask Supreme
Device: Laryngeal mask Supreme
 Device: Laryngeal mask Supreme evaluation
Device: Laryngeal mask Supreme evaluation
Other Name: Device: Laryngeal mask Supreme evaluation
Experimental: i-gel
Device: i-gel
 Device: i-gel evaluation
Device: i-gel evaluation
Other Name: Device: i-gel evaluation


Outcome Measures
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Primary Outcome Measures :
  1. Change in Airway Seal Pressure Values [ Time Frame: intraoperative ]
  2. insertion time [ Time Frame: intraoperative ]
    placement of airway device (second)


Secondary Outcome Measures :
  1. sore throat [ Time Frame: postoperative 1th hour and 24th hour ]
    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])

  2. dysphagia [ Time Frame: postoperative 1th hour and 24th hour ]
    postoperative pharyngolaryngeal morbidity- dysphagia (yes/no)

  3. dysphonia [ Time Frame: postoperative 1th hour and 24th hour ]
    postoperative pharyngolaryngeal morbidity- dysphonia (yes/no)


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03760679


Contacts
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Contact: Şule Özbilgin 05055252901 ozbilginsule@gmail.com
Contact: Sibel Büyükçoban sibelbuyukcoban@yahoo.com

Locations
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Turkey
Şule Özbilgin Recruiting
İzmir, Turkey, 35340
Contact: Şule Özbilgin    5055252901    ozbilginsule@gmail.com   
Principal Investigator: Sibel Büyükçoban, MD         
Sponsors and Collaborators
Dokuz Eylul University
Investigators
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Principal Investigator: Sibel Büyükçoban Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Intensive Care
More Information
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Responsible Party: Sule Ozbilgin, Investigator, Dokuz Eylul University
ClinicalTrials.gov Identifier: NCT03760679    
Other Study ID Numbers: 341-SBKAEK
First Posted: November 30, 2018    Key Record Dates
Last Update Posted: August 19, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sule Ozbilgin, Dokuz Eylul University:
laryngeal mask
geriatric
patient
Additional relevant MeSH terms:
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Chlorhexidine
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants