Airway MorbidityNCT02923427
I-gel vs LMA Supreme in Laparoscopic Gynecological Surgery
A study testing Laryngeal mask Supreme Evaluation and i-gel Evaluation in people with Airway Morbidity and Anaesthesia, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
To compare the effects of i-gel and Laryngeal mask airway Supreme (LMA-Supreme) on ventilation parameters and surgical view during Trendelenburg Position laparoscopic gynecological surgery in cases administered positive pressure ventilation without the use of neuromuscular agents. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Airway Morbidity, Anaesthesia
- 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
- 112 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2015to Nov 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists classification group I-II
- between 18-65 years
- undergoing elective laparoscopic gynecological surgery
Who cannot join
- Those with any neck or upper respiratory tract pathology
- Those at risk of gastric content regurgitation/aspiration (previous upper Gastrointestinal system surgery, known hiatus hernia, gastroesophageal reflux, history of peptic ulcers, full stomach, pregnancy)
- Those with low pulmonary compliance or high airway resistance (chronic pulmonary diseases)
- Obese patients (BMI >35)
- Those with throat pain, dysphagia and dysphonia
- Those with possible or previous difficult airway
Show all 9Show fewer
- Those with operations planned for longer than 4 hours
- Conversion to laparatomy
- Neuromuscular blocking agent used
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation
Izmir, 35340
About this study
Official title: Comparison of I-gel and LMA Supreme Without Neuromuscular Blocker in Laparoscopic Gynecological Surgery
To compare the effects of i-gel and Laryngeal mask airway Supreme (LMA-Supreme) on ventilation parameters and surgical view during Trendelenburg Position laparoscopic gynecological surgery in cases administered positive pressure ventilation without the use of neuromuscular agents.
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: LMA- Supreme
Procedure:
The investigation protocol contains the following sections:
- Induction of anaesthesia. For preoperative sedation 0.02 mg/kg midazolam IV will be administered. 2 minutes of 0.2 µ/kg/min remifentanil and 6 mg kg st-1 propofol infusion, IV 1-2 mg kg-1 propofol . No muscle relaxant will be used for insertion of the airway device.
- 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.
- Anesthesia maintenance will be ensured by 50% O2/air with 0.1-0.4 µ kg/min-1 remifentanil and 50-150 µ kg/ min-1 (4-10 mg/kg/hr) propofol IV infusion
- Functionality of the gastric drainage channel of the airway device: passage of a 14 G size tube.
- Measurement of airway seal pressure (oropharyngeal leak pressure (OLP): at baseline, and at 2 minutes after airway device insertion (T1), 10 minutes after insufflation (T2), before desufflation (T3), before removal of airway device (T4). The maximum pressure allowed is 40 cm H2O.
- Ventilatory mechanics and parameters and hemodynamic parameters are measured at baseline, and at T1, T2, T3 and T4.
- Perioperative complications: Cough, vomiting, laryngeal spasm, laryngeal Stridor, airway intervention requirements, hypoxia (SpO2 < 92%)
- 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 ( VAS:10-point scale), dysphonia (yes/no), dysphagia (yes/no).
- Conditions
- Airway Morbidity, Anaesthesia
- Being tested
- Laryngeal mask Supreme Evaluation, i-gel Evaluation
- Keywords
- laryngeal mask Supreme, i-gel, laparoscopic gynecological surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laryngeal mask Supreme EvaluationDevice
Evaluation of clinical performance in terms of Insertion, ventilation and complications
i-gel EvaluationDevice
Evaluation of clinical performance in terms of Insertion,ventilation and complications
| Study group | Role | What they receive |
|---|---|---|
| Laryngeal mask Supreme | Active comparator | Insertion of the "Laryngeal mask Supreme" and evaluation of its clinical performance Receives: Device: Laryngeal mask Supreme Evaluation |
| i-gel | Experimental | Insertion of the "i-gel" and evaluation of its clinical performance Receives: Device: i-gel Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Airway Seal Pressure Values
This value is important as it indicates the feasibility of positive pressure ventilation and the degree of airway protection from supracuff soiling. It is also used in LMA studies as an index of successful placement.Airway pressures of ≈20 cm H2O are typically required in routine practice.
Measured: At baseline and at 15, 30 and 60 minutes
Secondary outcomes (7)
Visual Quality
quality of surgical view will evaluate by the scala. quality of surgical view will be assessed with points from 1 to 4 by the surgeon blind to the airway device; (1:best, 4: worst).
Measured: during pneumoperitoneum
Gastric Tube Insertion
Number of Participants According to Ease of Gastric Tube Insertion.Ease of passage of a gastric tube as: very easy, easy, difficult or very difficult.
Measured: following airway device insertion up to 5 minutes
Postoperative Pharyngolaryngeal Morbidity
Sore throat evaluted by Visual Analogue Scale. The visual analog scale, also known as the graphic rating scale is a simple, valid and reliable subjective measure. Scores are ranked on a 10-cm line that stretches between two extremes - "no pain" and "worst pain". Total range provided"0 (no pain) to 10 (worst pain).
Measured: postoperative first hour and 24th hour
Sufficiency of Pneumoperitoneum
Number of Participants with Sufficiency of Pneumoperitoneum. Sufficiency of pneumoperitoneum for the surgical procedure according to surgeon, described as sufficient or insufficient questionaire.
Measured: baseline
Mean Airway Pressure Values
Mean airway pressure typically refers to the mean pressure applied during positive-pressure mechanical ventilation. Mean airway pressure correlates with alveolar ventilation, arterial oxygenation, hemodynamic performance, and barotrauma.
Measured: At baseline and at 15, 30 and 60 minutes
Dysphonia With Yes/no.
We evaluated while a patient was talking with us that the patient has dysphonia or not .
Measured: postoperative first hour and 24th hour
Disphagia
We asked the question that you have a pain while you were swallowing, yes or not.
Measured: postoperative first 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 posted4 Oct 2016 (estimated)
- Study startNov 2015
- Primary completionSep 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sule Ozbilgin, Dokuz Eylul University
- Investigators
- Ferim Günenç, MD, Study director, Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02923427
- Sponsor's protocol ID
- 266-SBKAEK
- Status last verified
- Oct 2020
- First submitted
- 22 Sep 2016
- Last updated
- 27 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of I-gel and LMA Supreme Without Neuromuscular Blocker in Laparoscopic Gynecological Surgery
- ClinicalTrials.gov ID
- NCT02923427
- Acronym / sponsor ID
- 266-SBKAEK
- Conditions
- Airway Morbidity, Anaesthesia
- Keywords
- laryngeal mask Supreme, i-gel, laparoscopic gynecological surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 4 Oct 2016 (estimated)
- Results
- Posted 8 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the effects of i-gel and Laryngeal mask airway Supreme (LMA-Supreme) on ventilation parameters and surgical view during Trendelenburg Position laparoscopic gynecological surgery in cases administered positive pressure ventilation without the use of neuromuscular agents.
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: LMA- Supreme
Procedure:
The investigation protocol contains the following sections:
- Induction of anaesthesia. For preoperative sedation 0.02 mg/kg midazolam IV will be administered. 2 minutes of 0.2 µ/kg/min remifentanil and 6 mg kg st-1 propofol infusion, IV 1-2 mg kg-1 propofol . No muscle relaxant will be used for insertion of the airway device.
- 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.
- Anesthesia maintenance will be ensured by 50% O2/air with 0.1-0.4 µ kg/min-1 remifentanil and 50-150 µ kg/ min-1 (4-10 mg/kg/hr) propofol IV infusion
- Functionality of the gastric drainage channel of the airway device: passage of a 14 G size tube.
- Measurement of airway seal pressure (oropharyngeal leak pressure (OLP): at baseline, and at 2 minutes after airway device insertion (T1), 10 minutes after insufflation (T2), before desufflation (T3), before removal of airway device (T4). The maximum pressure allowed is 40 cm H2O.
- Ventilatory mechanics and parameters and hemodynamic parameters are measured at baseline, and at T1, T2, T3 and T4.
- Perioperative complications: Cough, vomiting, laryngeal spasm, laryngeal Stridor, airway intervention requirements, hypoxia (SpO2 < 92%)
- 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 ( VAS: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 EvaluationInsertion of the "Laryngeal mask Supreme" and evaluation of its clinical performance |
| i-gel | Experimental | Device: i-gel EvaluationInsertion of the "i-gel" and evaluation of its clinical performance |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists classification group I-II
- between 18-65 years
- undergoing elective laparoscopic gynecological surgery
Key exclusion criteria (9 listed)
- Those with any neck or upper respiratory tract pathology
- Those at risk of gastric content regurgitation/aspiration (previous upper Gastrointestinal system surgery, known hiatus hernia, gastroesophageal reflux, history of peptic ulcers, full stomach, pregnancy)
- Those with low pulmonary compliance or high airway resistance (chronic pulmonary diseases)
- Obese patients (BMI >35)
- Those with throat pain, dysphagia and dysphonia
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 EvaluationEvaluation of clinical performance in terms of Insertion, ventilation and complications | Device | Laryngeal mask Supreme |
| i-gel EvaluationEvaluation of clinical performance in terms of Insertion,ventilation and complications | Device | i-gel |
Primary outcome
Airway Seal Pressure Values
Time frame: At baseline and at 15, 30 and 60 minutes
This value is important as it indicates the feasibility of positive pressure ventilation and the degree of airway protection from supracuff soiling. It is also used in LMA studies as an index of successful placement.Airway pressures of ≈20 cm H2O are typically required in routine practice.
7 secondary outcomes
Visual Quality
Time frame: during pneumoperitoneum
Gastric Tube Insertion
Time frame: following airway device insertion up to 5 minutes
Postoperative Pharyngolaryngeal Morbidity
Time frame: postoperative first hour and 24th hour
Sufficiency of Pneumoperitoneum
Time frame: baseline
Mean Airway Pressure Values
Time frame: At baseline and at 15, 30 and 60 minutes
Dysphonia With Yes/no.
Time frame: postoperative first hour and 24th hour
Disphagia
Time frame: postoperative first hour and 24th hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
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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.
Ferim Günenç, MD study director
Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation
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 and Anaesthesia, 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 3 inclusion and 9 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: finished, as of the sponsor's last update on 27 Oct 2020. 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?
Yes. Results are posted in the registry (first posted 8 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Airway Seal Pressure Values (time frame: At baseline and at 15, 30 and 60 minutes). 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 27 Oct 2020.