HealthyIGE(L)MANCT00668278
I-Gel Versus Disposable Laryngeal Mask (LMA) for General Anesthesia (GA) With Controlled Ventilation
A study testing Insertion of laryngeal mask airway (AuraOnce mask), Insertion of I-gel airway and Measurement of airway pressures in people with Healthy, run by Northern Health and Social Care Trust.
Trial summary
Randomized controlled trial comparing performance of the I-gel and disposable Laryngeal Mask Airways under controlled ventilation. 200 patients, 100 in each arm. Measurement of peak airway and sealing pressures. Postoperative questionnaires at 1 and 24hrs. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Insertion of laryngeal mask airway (AuraOnce mask), Insertion of I-gel airway and Measurement of airway pressures
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Feb 2008to Jan 2009
- 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 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females.
- Age 18-89 inclusive.
- ASA grade 1-2.
- Elective surgery
Who cannot join
- Emergency surgery.
- Surgery within the peritoneum.
- Surgery requiring prone or steep head-down positioning.
- Patients at increased risk of aspiration
About this study
Official title: I-Gel Versus Disposable Laryngeal Mask Airway for General Anesthesia With Controlled Ventilation
Randomized controlled trial comparing performance of the I-gel and disposable Laryngeal Mask Airways under controlled ventilation. 200 patients, 100 in each arm. Measurement of peak airway and sealing pressures. Postoperative questionnaires at 1 and 24hrs.
Hypothesis
There is no difference between the performance* of the I-gel and disposable laryngeal mask airways for controlled ventilation under general anesthesia.
*as defined by peak airway pressure and sealing pressures.
- Conditions
- Healthy
- Being tested
- Insertion of laryngeal mask airway (AuraOnce mask), Insertion of I-gel airway, Measurement of airway pressures
- Keywords
- Supraglottic airway, I-gel, Laryngeal mask, Controlled ventilation, Peak airway pressure, Seal pressure, Anaesthesia, Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insertion of laryngeal mask airway (AuraOnce mask)Device
Insertion of laryngeal mask airway under anaesthesia: Fentanyl 1-2mcg/kg; Propofol 1-3mg/kg; Atracurium 0.5mg/kg; AuraOnce disposable laryngeal mask
Insertion of I-gel airwayDevice
Insertion of I-gel airway under anaesthesia; Fentanyl 1-2mcg/kg; Propofol 1-3mg/kg; Atracurium 0.5mg/kg
Measurement of airway pressuresOther
Measurement of peak airway pressure under steady state; measurement of device seal pressure
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Laryngeal Mask Airway insertion Receives: Device: Insertion of laryngeal mask airway (AuraOnce mask); Other: Measurement of airway pressures |
| B | Active comparator | I-gel insertion Receives: Device: Insertion of I-gel airway; Other: Measurement of airway pressures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sealing pressure and peak airway pressure.
Measured: Under anaesthesia.
Secondary outcomes (1)
Postoperative patient symptoms
Measured: 1hr and 24hrs postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2008 (estimated)
- Study startFeb 2008
- Primary completionDec 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northern Health and Social Care Trust
- Sponsor type
- Other government
- Collaborators
- Antrim Area Hospital
- Investigators
- William J Donaldson, MBBS FRCA, Principal investigator, Antrim Area Hospital, Northern Health and Social Care Trust, National Health Service, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00668278
- Sponsor's protocol ID
- 07/NIR01/124
- Acronym
- IGE(L)MA
- Status last verified
- Jan 2009
- First submitted
- 25 Apr 2008
- Last updated
- 29 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- I-Gel Versus Disposable Laryngeal Mask Airway for General Anesthesia With Controlled Ventilation
- ClinicalTrials.gov ID
- NCT00668278
- Acronym / sponsor ID
- IGE(L)MA / 07/NIR01/124
- Conditions
- Healthy
- Keywords
- Supraglottic airway, I-gel, Laryngeal mask, Controlled ventilation, Peak airway pressure, Seal pressure, Anaesthesia, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Northern Health and Social Care TrustOther government
- Collaborators
- Antrim Area Hospital
- Study start
- Feb 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 29 Apr 2008 (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.
Randomized controlled trial comparing performance of the I-gel and disposable Laryngeal Mask Airways under controlled ventilation. 200 patients, 100 in each arm. Measurement of peak airway and sealing pressures. Postoperative questionnaires at 1 and 24hrs.
Hypothesis
There is no difference between the performance* of the I-gel and disposable laryngeal mask airways for controlled ventilation under general anesthesia.
*as defined by peak airway pressure and sealing pressures.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Device: Insertion of laryngeal mask airway (AuraOnce mask), Other: Measurement of airway pressuresLaryngeal Mask Airway insertion |
| B | Active comparator | Device: Insertion of I-gel airway, Other: Measurement of airway pressuresI-gel insertion |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females.
- Age 18-89 inclusive.
- ASA grade 1-2.
- Elective surgery
Key exclusion criteria (4 listed)
- Emergency surgery.
- Surgery within the peritoneum.
- Surgery requiring prone or steep head-down positioning.
- Patients at increased risk of aspiration
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 |
|---|---|---|
| Insertion of laryngeal mask airway (AuraOnce mask)Insertion of laryngeal mask airway under anaesthesia: Fentanyl 1-2mcg/kg; Propofol 1-3mg/kg; Atracurium 0.5mg/kg; AuraOnce disposable laryngeal mask | Device | A |
| Insertion of I-gel airwayInsertion of I-gel airway under anaesthesia; Fentanyl 1-2mcg/kg; Propofol 1-3mg/kg; Atracurium 0.5mg/kg | Device | B |
| Measurement of airway pressuresMeasurement of peak airway pressure under steady state; measurement of device seal pressure | Other | A, B |
Primary outcome
Sealing pressure and peak airway pressure.
Time frame: Under anaesthesia.
1 secondary outcome
Postoperative patient symptoms
Time frame: 1hr and 24hrs postoperatively
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 29 Jan 2009.
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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.
William J Donaldson, MBBS FRCA principal investigator
Antrim Area Hospital, Northern Health and Social Care Trust, National Health Service, United Kingdom
Questions about this trial
What is this clinical trial studying?
A study testing Insertion of laryngeal mask airway (AuraOnce mask), Insertion of I-gel airway and Measurement of airway pressures in people with Healthy, run by Northern Health and Social Care Trust.
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 4 inclusion and 4 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 29 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
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?
Sealing pressure and peak airway pressure. (time frame: Under anaesthesia.). 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 29 Jan 2009.