Airway MorbidityNCT03760679
Laryngeal Mask Supreme and I-Gel in Edentulate Geriatric Patients
A study testing Laryngeal mask Supreme evaluation and i-gel evaluation in people with Airway Morbidity, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Airway Morbidity
- What is being tested?
- Laryngeal mask Supreme evaluation and i-gel evaluation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2018to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- American Society of Anesthesiologists Classification I-III patients
- patients aged 65 years and older
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Sibel Büyükçoban contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Şule Özbilgin
Izmir, 35340
Şule Özbilgin, 5055252901, ozbilginsule@gmail.com
Sibel Büyükçoban, MD
About this study
Official title: 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.
Read the 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:
- 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.
- 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).
- 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.
- 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.
- 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.
- 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.
- Perioperative complications: Cough, vomiting, laryngeal spasm, laryngeal Stridor
- 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).
- Conditions
- Airway Morbidity
- Being tested
- Laryngeal mask Supreme evaluation, i-gel evaluation
- Keywords
- laryngeal mask, geriatric, patient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laryngeal mask Supreme evaluationDevice
Also called Device: Laryngeal mask Supreme evaluation
Device: Laryngeal mask Supreme evaluation
i-gel evaluationDevice
Also called Device: i-gel evaluation
Device: i-gel evaluation
| Study group | Role | What they receive |
|---|---|---|
| Laryngeal mask Supreme | Active comparator | Device: Laryngeal mask Supreme Receives: Device: Laryngeal mask Supreme evaluation |
| i-gel | Experimental | Device: i-gel Receives: Device: i-gel evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Airway Seal Pressure Values
Measured: intraoperative
insertion time
placement of airway device (second)
Measured: intraoperative
Secondary outcomes (3)
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])
Measured: postoperative 1th hour and 24th hour
dysphagia
postoperative pharyngolaryngeal morbidity- dysphagia (yes/no)
Measured: postoperative 1th hour and 24th hour
dysphonia
postoperative pharyngolaryngeal morbidity- dysphonia (yes/no)
Measured: postoperative 1th hour and 24th hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2018
- Study start1 Aug 2018
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway MorbidityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sule Ozbilgin, Dokuz Eylul University
- Investigators
- Sibel Büyükçoban, Principal investigator, Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03760679
- Sponsor's protocol ID
- 341-SBKAEK
- Status last verified
- Mar 2022
- First submitted
- 30 Aug 2018
- Last updated
- 28 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Laryngeal Mask Supreme and I-Gel in Edentulate Geriatric Patients
- ClinicalTrials.gov ID
- NCT03760679
- Acronym / sponsor ID
- 341-SBKAEK
- Conditions
- Airway Morbidity
- Keywords
- laryngeal mask, geriatric, patient
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 30 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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).
- 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.
- 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.
- 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.
- 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.
- Perioperative complications: Cough, vomiting, laryngeal spasm, laryngeal Stridor
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laryngeal mask Supreme | Active comparator | Device: Laryngeal mask Supreme evaluationDevice: Laryngeal mask Supreme |
| i-gel | Experimental | Device: i-gel evaluationDevice: i-gel |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists Classification I-III patients
- patients aged 65 years and older
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laryngeal mask Supreme evaluationAlso: Device: Laryngeal mask Supreme evaluationDevice: Laryngeal mask Supreme evaluation | Device | Laryngeal mask Supreme |
| i-gel evaluationAlso: Device: i-gel evaluationDevice: i-gel evaluation | Device | i-gel |
Primary outcome
Change in Airway Seal Pressure Values
Time frame: intraoperative
insertion time
Time frame: intraoperative
placement of airway device (second)
3 secondary outcomes
sore throat
Time frame: postoperative 1th hour and 24th hour
dysphagia
Time frame: postoperative 1th hour and 24th hour
dysphonia
Time frame: postoperative 1th hour and 24th hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sibel Büyükçoban contact
Sibel Büyükçoban principal investigator
Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laryngeal mask Supreme evaluation and i-gel evaluation in people with Airway Morbidity, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Şule Özbilgin (05055252901, ozbilginsule@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Airway Seal Pressure Values (time frame: intraoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2022.