Laryngeal Mask Supreme and I-Gel in Edentulate Geriatric Patients
Comparison of Laryngeal Mask Supreme and I-Gel in Edentulate Geriatric Patients
1 other identifier
interventional
124
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2018
CompletedFirst Submitted
Initial submission to the registry
August 30, 2018
CompletedFirst Posted
Study publicly available on registry
November 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedMarch 28, 2022
March 1, 2022
6.1 years
August 30, 2018
March 25, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Airway Seal Pressure Values
intraoperative
insertion time
placement of airway device (second)
intraoperative
Secondary Outcomes (3)
sore throat
postoperative 1th hour and 24th hour
dysphagia
postoperative 1th hour and 24th hour
dysphonia
postoperative 1th hour and 24th hour
Study Arms (2)
Laryngeal mask Supreme
ACTIVE COMPARATORDevice: Laryngeal mask Supreme
i-gel
EXPERIMENTALDevice: i-gel
Interventions
Device: Laryngeal mask Supreme evaluation
Eligibility Criteria
You may qualify if:
- American Society of Anesthesiologists Classification I-III patients
- patients aged 65 years and older
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Şule Özbilgin
Izmir, 35340, Turkey (Türkiye)
Study Officials
- PRINCIPAL INVESTIGATOR
Sibel Büyükçoban
Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Intensive Care
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Investigator
Study Record Dates
First Submitted
August 30, 2018
First Posted
November 30, 2018
Study Start
August 1, 2018
Primary Completion
September 1, 2024
Study Completion
December 1, 2024
Last Updated
March 28, 2022
Record last verified: 2022-03