Airway MorbidityNCT03760692
I-gel vs Ambu AuraGain in Laparoscopic Gynecological Surgery
A study testing i-gel and Ambu AuroGain in people with Airway Morbidity and Anesthesia, run by Dokuz Eylul University at 2 sites in 2 countries.
Trial summary
To compare the effects of i-gel and Ambu AuraGain 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, Anesthesia
- What is being tested?
- i-gel and Ambu AuroGain
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Nov 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA classification 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 GIS 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 laparotomy
- Neuromuscular blocking agent used
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Spain1 site
Sureste University Hospital, Department of Anesthesiology and Critical Care
Madrid
Turkey (Türkiye)1 site
Dokuz Eylul University, School of Medicine, Department of Anesthesiology and Intensive Care
Izmir
About this study
Official title: Comparison of I-gel and Ambu AuraGain Without Neuromuscular Blocker in Laparoscopic Gynecological Surgery
To compare the effects of i-gel and Ambu AuraGain 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, multicenter, 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 i-gel Group Ambu AuraGain
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.
- Anesthesia maintenance will be ensured by 50% O2/air with 0.1-0.4 µ kg/min-1 remifentanil and 4-10 mg/kg/hr propofol IV infusion
- Functionality of the gastric drainage channel of the airway device
- 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, Anesthesia
- Being tested
- i-gel, Ambu AuroGain
- Keywords
- supraglottic airway device, laparoscopic gynecological surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
i-gelDevice
Also called Group i-gel
Evaluation of clinical performance in terms of insertion, ventilation and complications
Ambu AuroGainDevice
Also called Group Ambu AuroGain
Evaluation of clinical performance in terms of insertion, ventilation and complications
| Study group | Role | What they receive |
|---|---|---|
| Group i-gel | Active comparator | Insertion of the airway device. The size of the airway device used is based on the manufacturers' recommendations and evaluation of its clinical performance Receives: Device: i-gel |
| Group Ambu Auragain | Experimental | Insertion of the airway device. The size of the airway device used is based on the manufacturers' recommendations and evaluation of its clinical performance Receives: Device: Ambu AuroGain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insertion time
The time taken to successfully place the device in seconds
Measured: intraoperative
Change in airway seal pressure
The maximum oropharyngeal leak pressure attained for each device.
Measured: intraoperative
Secondary outcomes (1)
Number of attempts at insertion
The number of repeated attempts required for successfully placing the device. Each device was given a chance of 3 attempts if still unsuccessful after 3 attempts another device was placed.
Measured: intraoperative
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 Nov 2018
- Primary completion1 Nov 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
- Model description
- Prospective, multicenter, randomized
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 102 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
- Sule Ozbilgin, MD, Study director, Dokuz Eylul University, School of Medicine, Department of Anesthesiology and Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03760692
- Sponsor's protocol ID
- 351-SBKAEK
- Other IDs
- HUSE 012-ANR-2017
- Status last verified
- Mar 2022
- First submitted
- 27 Nov 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 I-gel and Ambu AuraGain Without Neuromuscular Blocker in Laparoscopic Gynecological Surgery
- ClinicalTrials.gov ID
- NCT03760692
- Acronym / sponsor ID
- 351-SBKAEK
- Conditions
- Airway Morbidity, Anesthesia
- Keywords
- supraglottic airway device, laparoscopic gynecological surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Nov 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.
To compare the effects of i-gel and Ambu AuraGain 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, multicenter, 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 i-gel Group Ambu AuraGain
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.
- Anesthesia maintenance will be ensured by 50% O2/air with 0.1-0.4 µ kg/min-1 remifentanil and 4-10 mg/kg/hr propofol IV infusion
- Functionality of the gastric drainage channel of the airway device
- 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
- Model description
- Prospective, multicenter, randomized
| Arm | Type | Receives |
|---|---|---|
| Group i-gel | Active comparator | Device: i-gelInsertion of the airway device. The size of the airway device used is based on the manufacturers' recommendations and evaluation of its clinical performance |
| Group Ambu Auragain | Experimental | Device: Ambu AuroGainInsertion of the airway device. The size of the airway device used is based on the manufacturers' recommendations 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)
- ASA classification 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 GIS 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 |
|---|---|---|
| i-gelAlso: Group i-gelEvaluation of clinical performance in terms of insertion, ventilation and complications | Device | Group i-gel |
| Ambu AuroGainAlso: Group Ambu AuroGainEvaluation of clinical performance in terms of insertion, ventilation and complications | Device | Group Ambu Auragain |
Primary outcome
Insertion time
Time frame: intraoperative
The time taken to successfully place the device in seconds
Change in airway seal pressure
Time frame: intraoperative
The maximum oropharyngeal leak pressure attained for each device.
1 secondary outcome
Number of attempts at insertion
Time frame: intraoperative
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
Related trials for Airway Morbidity
Not yet recruiting
Effect of Laryngeal Mask Cuff Shape on Pharyngeal Stress
Anesthesia, General, Airway Management
Not yet recruitingObservational study
eCPAP Follow-up at School Age
Lung Function
Not yet recruitingObservational study
Can the "Face Index"; an Anthropometric Measurement, Predict Difficult Laryngoscopy and Intubation?
Anesthesia Intubation Complication, Laryngoscopy
Recruiting
Automated Oxygen Control in Preterms on Non-invasive Ventilation
Infant, Premature
Recruiting
Cost Effective Air Filtration Intervention in Low-Income Housing to Reduce Asthma Morbidity
Asthma Attack, Lung Function
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.
Sule Ozbilgin, MD study director
Dokuz Eylul University, School of Medicine, Department of Anesthesiology and Intensive Care
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing i-gel and Ambu AuroGain in people with Airway Morbidity and Anesthesia, run by Dokuz Eylul University at 2 sites in 2 countries.
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: 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 2 sites in Spain, 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?
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?
Insertion time (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.