LaparoscopyNCT02511652
Ambu AuraGain vs LMA Supreme in Laparoscopic Surgery
A study testing Ambu AuraGain evaluation, LMA Supreme evaluation and Laparoscopic surgery in people with Laparoscopy and Airway Management, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
The aim of the study is to compare the performance of two supraglottic airway devices (SGA), the new Ambu AuraGain and the LMA Supreme, in sixty female patients undergoing gynaecologic laparoscopy in the trendelemburg position. Primary outcome is the airway seal pressure. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Laparoscopy, Airway Management, Supraglottic Airway Devices
- What is being tested?
- Ambu AuraGain evaluation, LMA Supreme evaluation and Laparoscopic surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2015to Dec 2015
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients evaluated as eligible for a SGA
- ASA I-III
- Without criteria for difficult airway
- Body Mass Index ≤ 35 kg/m2
- The patient has signed the Informed Consent
- The patient understands his or hers rights and consequences related to this investigation
Who cannot join
- Planned operation time > 2 hours
- High risk of regurgitation
- Respiratory tract pathology
- Preoperative sore throat
- Patients with a known or predicted difficult airway
- Patients diagnosed with dementia or any mental handicaps
- Patient who has a guardian.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Ambulatory Surgery, Hospital Clinic de Barcelona
Barcelona, Barcelona, 08036
About this study
Official title: Comparison of the Ambu AuraGain vs. LMA Supreme in Paralysed Patients Undergoing Gynecologic Laparoscopic Surgery in the Trendelemburg Position
The aim of the study is to compare the performance of two supraglottic airway devices (SGA), the new Ambu AuraGain and the LMA Supreme, in sixty female patients undergoing gynaecologic laparoscopy in the trendelemburg position.
Primary outcome is the airway seal pressure. Secondary outcomes are ease of insertion, quality of ventilation, endoscopic view of the glottis, gastric tube passage and complications.
Read the detailed description
The patients are randomly assigned to 2 groups:
- Group 1: Ambu AuraGain.
- Group 2: LMA Supreme, Teleflex
Procedure:
The investigation protocol contains the following sections:
- Induction of anaesthesia. Intravenous infusion of remifentanil and propofol targeting the effect site (2-4 ng/ml and 4-6 µg/ml respectively). No muscle relaxant will be used for insertion of the SGA. Rocuronium 0.2 mg/Kg will be administered before initiation of pneumoperitoneum.
- Insertion of the SGAs. The size of the SGA 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 Position of the device is adjusted if needed. Data recorded: size of SGA, time an number of attempts.
- Fibreoptic evaluation of the SGAs anatomical position: complete view of the vocal cords (I), epiglottis visible inside, but not causing obstruction (II), epiglottis visible and obstructing the glottic inlet (III), or glottic structures not identified (IV).
- Functionality of the gastric drainage channel of the SGAs: passage of a 16 G size tube.
- Measurement of airway seal pressure (oropharyngeal leak pressure (OLP): at baseline, and at 15, 30 and 60 minutes. The maximum pressure allowed is 40 cm H2O.
- Ventilatory mechanics and parameters are measured at baseline, and at 15, 30 and 60 minutes. Perioperative complications: Hiccup, gastric distension, regurgitation / Aspiration, airway obstruction, laryngospasm, dental, mucosal or tongue injury, hypoxia (SpO2 < 92%)
- Removal of the SGAs: Presence of blood - 3 level grading (+/++/+++) Postoperative complications: sore throat, hoarseness, dysphonia, dysphagia, dysphagia: 3-point scale
- Conditions
- Laparoscopy, Airway Management, Supraglottic Airway Devices
- Being tested
- Ambu AuraGain evaluation, LMA Supreme evaluation, Laparoscopic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambu AuraGain evaluationDevice
Evaluation of clinical performance in terms of Insertion, ventilation, position and complications
LMA Supreme evaluationDevice
Evaluation of clinical performance in terms of Insertion, ventilation, position and complications
Laparoscopic surgeryProcedure or surgery
Gynecologic laparoscopic surgery in the trendelemburg position
| Study group | Role | What they receive |
|---|---|---|
| Ambu AuraGain | Active comparator | Insertion of the supraglottic device and evaluation of its clinical performance Receives: Device: Ambu AuraGain evaluation; Procedure: Laparoscopic surgery |
| LMA Supreme | Active comparator | Insertion of the supraglottic device and evaluation of its clinical performance Receives: Device: LMA Supreme evaluation; Procedure: Laparoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Airway seal pressure
Maximum airway pressure that the device can achieve without oropharyngeal leak of gas.
Measured: At 15 minutes
Secondary outcomes (5)
Ease of insertion of the device
Time needed to insert the device
Measured: Baseline
Change in Quality of ventilation
number of manoeuvres/corrections required
Measured: At baseline and at 15, 30 and 60 minutes
Endoscopic view of glottic structures
Assessment of alignment with the glottic inlet as: complete view of the vocal cords (I), epiglottis visible inside, but not causing any obstruction (II), epiglottis visible and causing obstruction (III) or glottis not identified (IV)
Measured: At 15 minutes
Gastric tube insertion
Ease of passage of a gastric tube as: easy, difficult or impossible
Measured: At 5 minutes
Incidence of perioperative complications
number of patients with adverse events: Airway obstruction, desaturation, Aspiration, oropharyngeal trauma, sore throat
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaparoscopyStudies 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
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Ambu A/S
- Responsible party
- Principal investigator, Ana M Lopez, Hospital Clinic of Barcelona
- Investigators
- Ana M Lopez, MD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02511652
- Sponsor's protocol ID
- HBarcelona
- Status last verified
- Feb 2016
- First submitted
- 20 Jul 2015
- Last updated
- 22 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Ambu AuraGain vs. LMA Supreme in Paralysed Patients Undergoing Gynecologic Laparoscopic Surgery in the Trendelemburg Position
- ClinicalTrials.gov ID
- NCT02511652
- Acronym / sponsor ID
- HBarcelona
- Conditions
- Laparoscopy, Airway Management, Supraglottic Airway Devices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- Ambu A/S
- Study start
- Jun 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 30 Jul 2015 (estimated)
- 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 aim of the study is to compare the performance of two supraglottic airway devices (SGA), the new Ambu AuraGain and the LMA Supreme, in sixty female patients undergoing gynaecologic laparoscopy in the trendelemburg position.
Primary outcome is the airway seal pressure. Secondary outcomes are ease of insertion, quality of ventilation, endoscopic view of the glottis, gastric tube passage and complications.
Detailed description
The patients are randomly assigned to 2 groups:
- Group 1: Ambu AuraGain.
- Group 2: LMA Supreme, Teleflex
Procedure:
The investigation protocol contains the following sections:
- Induction of anaesthesia. Intravenous infusion of remifentanil and propofol targeting the effect site (2-4 ng/ml and 4-6 µg/ml respectively). No muscle relaxant will be used for insertion of the SGA. Rocuronium 0.2 mg/Kg will be administered before initiation of pneumoperitoneum.
- Insertion of the SGAs. The size of the SGA 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 Position of the device is adjusted if needed. Data recorded: size of SGA, time an number of attempts.
- Fibreoptic evaluation of the SGAs anatomical position: complete view of the vocal cords (I), epiglottis visible inside, but not causing obstruction (II), epiglottis visible and obstructing the glottic inlet (III), or glottic structures not identified (IV).
- Functionality of the gastric drainage channel of the SGAs: passage of a 16 G size tube.
- Measurement of airway seal pressure (oropharyngeal leak pressure (OLP): at baseline, and at 15, 30 and 60 minutes. The maximum pressure allowed is 40 cm H2O.
- Ventilatory mechanics and parameters are measured at baseline, and at 15, 30 and 60 minutes. Perioperative complications: Hiccup, gastric distension, regurgitation / Aspiration, airway obstruction, laryngospasm, dental, mucosal or tongue injury, hypoxia (SpO2 < 92%)
- Removal of the SGAs: Presence of blood - 3 level grading (+/++/+++) Postoperative complications: sore throat, hoarseness, dysphonia, dysphagia, dysphagia: 3-point scale
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ambu AuraGain | Active comparator | Device: Ambu AuraGain evaluation, Procedure: Laparoscopic surgeryInsertion of the supraglottic device and evaluation of its clinical performance |
| LMA Supreme | Active comparator | Device: LMA Supreme evaluation, Procedure: Laparoscopic surgeryInsertion of the supraglottic device and evaluation of its clinical performance |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients evaluated as eligible for a SGA
- ASA I-III
- Without criteria for difficult airway
- Body Mass Index ≤ 35 kg/m2
- The patient has signed the Informed Consent
Key exclusion criteria (7 listed)
- Planned operation time > 2 hours
- High risk of regurgitation
- Respiratory tract pathology
- Preoperative sore throat
- Patients with a known or predicted difficult airway
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 |
|---|---|---|
| Ambu AuraGain evaluationEvaluation of clinical performance in terms of Insertion, ventilation, position and complications | Device | Ambu AuraGain |
| LMA Supreme evaluationEvaluation of clinical performance in terms of Insertion, ventilation, position and complications | Device | LMA Supreme |
| Laparoscopic surgeryGynecologic laparoscopic surgery in the trendelemburg position | Procedure or surgery | Ambu AuraGain, LMA Supreme |
Primary outcome
Airway seal pressure
Time frame: At 15 minutes
Maximum airway pressure that the device can achieve without oropharyngeal leak of gas.
5 secondary outcomes
Ease of insertion of the device
Time frame: Baseline
Change in Quality of ventilation
Time frame: At baseline and at 15, 30 and 60 minutes
Endoscopic view of glottic structures
Time frame: At 15 minutes
Gastric tube insertion
Time frame: At 5 minutes
Incidence of perioperative complications
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2016.
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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.
Ana M Lopez, MD principal investigator
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ambu AuraGain evaluation, LMA Supreme evaluation and Laparoscopic surgery in people with Laparoscopy and Airway Management, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 6 inclusion and 7 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 22 Feb 2016. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: At 15 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 22 Feb 2016.