Laryngeal MasksNCT01704118
Comparison of Size 1 I-gel and ProSeal Laryngeal Mask
A study testing I-gel and ProSeal Laryngeal mask in people with Laryngeal Masks, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
Objective of this prospective, randomized and controlled study is to compare the performances of recently-released size 1 I-gel and size 1 PLMA proven to be superior to classical LMA with prospective studies. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Laryngeal Masks
- What is being tested?
- I-gel and ProSeal Laryngeal mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2012to Oct 2012
- 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 Up to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants and neonates, that to be used supraglottic airway and that plan to be taken elective surgery
Who cannot join
- Infants having a history of pulmonary disease and expect to have aspiration (gastroesophageal reflux, gastrointestinal stenosis or stricture) and a difficult airway
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Inonu University Turgut Ozal Medical Center
Malatya, 44315
About this study
Official title: Is Size 1 I-gel More Effective Than Size 1 ProSeal Laryngeal Mask for Anesthetized Infants and Neonates?
Objective of this prospective, randomized and controlled study is to compare the performances of recently-released size 1 I-gel and size 1 PLMA proven to be superior to classical LMA with prospective studies. In this study, primer endpoint was value of airway leak pressure and secondary insertion time, insertion success and conditions, initial airway quality, hemodynamic parameters, fiberoptic view and complications will be assessed.
Read the detailed description
Routine monitorization will be performed. Lidocaine 1 mg.kg-1, remifentanil 1 mcg.kg-1 (slow bolus in approximately 1 minute) and 3 mg.kg-1 propofol will be administered in anaesthesia induction.
In Group P, PLMA with fully deflated cuff and applied water-based lubricant, will be inserted using a metal introducer. After insertion, cuff will be inflated with a recommended volume of air and then cuff pressure will be adjusted to 60 cm H2O with manometer.
In Group I, I-gel with its cuff lubricated will be orally inserted along the hard palate until resistance will be felt, as recommended by the manufacturer.
The time between picking up the prepared PLMA (with introducer and deflated cuff) or I-gel and the appearance of the first stable capnographic trace will be recorded as the insertion time. The conditions for insertion will be ere scored according to mouth (1: full, 2: partial, 3: nil), gagging or coughing (1: nil, 2: slight, 3: gross), swallowing (1: nil, 2: slight, 3: gross), head or limb movement (1: nil, 2: slight, 3: gross), laryngospasm (1: nil, 2: slight, 3: complete) and ease of insertion (1: easy, 2: difficult, 3: impossible).
Fresh gas flow will be adjusted to 3 L.min-1, and after closing the expiratory valve the airway pressure at which an audible leak in the mouth occurred will recorded as the 'Pleak'. When Pleak reach 35 cm H2O, expiratory valve will be opened.
Anatomical position of airway device will viewed by inserting fiberoptic bronchoscope through the ventilation tube.
Complications encountered during and at the end of the operation such as desaturation (sPO2 less than 90%), gastric insufflation, aspiration, laryngospasm, bronchospasm and blood stain on the airway device during removal will be recorded.
- Conditions
- Laryngeal Masks
- Being tested
- I-gel, ProSeal Laryngeal mask
- Keywords
- I-gel, ProSeal laryngeal mask, small infants, neonates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-gelDevice
Supraglottic airway device
ProSeal Laryngeal maskDevice
Also called PLMA
Supraglottic airway device
| Study group | Role | What they receive |
|---|---|---|
| I-gel | Experimental | I-gel (Intersurgical Ltd, Wokingham, Berkshire, UK) is a disposable supraglottic airway device with a non-inflatable cuff in which part of that is fixed on glottis is made of thermoplastic elastomer, unlike other laryngeal masks Receives: Device: I-gel |
| ProSeal Laryngeal mask | Active comparator | ProSeal laryngeal mask (PLMA) (LMA North America, Inc., San Diego, USA) is a modified type of LMA (larger and deeper bowl and enlarged and softer cuff) with gastric drainage tube. Receives: Device: ProSeal Laryngeal mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Airway leak pressure
Fresh gas flow will adjust to 3 L.min-1, and after closing the expiratory valve the airway pressure at which an audible leak in the mouth occurred will be recorded as the 'Pleak'.
Measured: 1 year (After anesthesia induction)
Secondary outcomes (4)
Insertion time and conditions
The time between picking up the device and the appearance of the first stable capnographic trace will be recorded as the insertion time. The conditions for insertion were scored according to mouth (1: full, 2: partial, 3: nil), gagging or coughing (1: nil, 2: slight, 3: gross), swallowing (1: nil, 2: slight, 3: gross), head or limb movement (1: nil, 2: slight, 3: gross), laryngospasm (1: nil, 2: slight, 3: complete) and ease of insertion (1: easy, 2: difficult, 3: impossible).
Measured: 1year (During maintainance of anesthesia)
Initial airway quality
Initial airway quality will be evaluated with manual ventilation by adjusting APL valve to 20 cm H2O. Evaluation will be performed with a scale as excellent (no leaks heard), good/acceptable (a slight, clinically insignificant leak, sufficient ventilation) and poor/unacceptable (significant leak and insufficient ventilation which requires reposition or relocation of device) by listening to lungs, epigastrium and perilaryngeal field and observing the expansion of thorax.
Measured: During maintainance of anesthesia
Evaluation of fiberoptic view
The breathing system will be disconnected and fiberoptic bronchoscope will be inserted through the ventilation tube to evaluate glottic view. Fiberoptic images will be recorded by using a digital camera. The images will be graded according to the score of 1 to 5.
Measured: 1 year (During maintainance of anesthesia)
Complications
Complications encountered during and at the end of the operation such as desaturation, gastric insufflation, aspiration, laryngospasm, bronchospasm and blood stain on the airway device during removal will be recorded.
Measured: 1year(During maintainance of anesthesia)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2012 (estimated)
- Study startJan 2012
- Primary completionSep 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Laryngeal MasksStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulay ERDOGAN KAYHAN, Inonu University
- Investigators
- Gulay Erdogan Kayhan, Study director, Assistant Professor, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01704118
- Sponsor's protocol ID
- Inonu University
- Status last verified
- Oct 2012
- First submitted
- 4 Oct 2012
- Last updated
- 11 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kayhan GE, Begec Z, Sanli M, Gedik E, Durmus M. Performance of size 1 I-gel compared with size 1 ProSeal laryngeal mask in anesthetized infants and neonates. ScientificWorldJournal. 2015;2015:426186. doi: 10.1155/2015/426186. Epub 2015 Feb 22.
PubMed 25793219
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Size 1 I-gel More Effective Than Size 1 ProSeal Laryngeal Mask for Anesthetized Infants and Neonates?
- ClinicalTrials.gov ID
- NCT01704118
- Acronym / sponsor ID
- Inonu University
- Conditions
- Laryngeal Masks
- Keywords
- I-gel, ProSeal laryngeal mask, small infants, neonates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 11 Oct 2012 (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.
Objective of this prospective, randomized and controlled study is to compare the performances of recently-released size 1 I-gel and size 1 PLMA proven to be superior to classical LMA with prospective studies. In this study, primer endpoint was value of airway leak pressure and secondary insertion time, insertion success and conditions, initial airway quality, hemodynamic parameters, fiberoptic view and complications will be assessed.
Detailed description
Routine monitorization will be performed. Lidocaine 1 mg.kg-1, remifentanil 1 mcg.kg-1 (slow bolus in approximately 1 minute) and 3 mg.kg-1 propofol will be administered in anaesthesia induction.
In Group P, PLMA with fully deflated cuff and applied water-based lubricant, will be inserted using a metal introducer. After insertion, cuff will be inflated with a recommended volume of air and then cuff pressure will be adjusted to 60 cm H2O with manometer.
In Group I, I-gel with its cuff lubricated will be orally inserted along the hard palate until resistance will be felt, as recommended by the manufacturer.
The time between picking up the prepared PLMA (with introducer and deflated cuff) or I-gel and the appearance of the first stable capnographic trace will be recorded as the insertion time. The conditions for insertion will be ere scored according to mouth (1: full, 2: partial, 3: nil), gagging or coughing (1: nil, 2: slight, 3: gross), swallowing (1: nil, 2: slight, 3: gross), head or limb movement (1: nil, 2: slight, 3: gross), laryngospasm (1: nil, 2: slight, 3: complete) and ease of insertion (1: easy, 2: difficult, 3: impossible).
Fresh gas flow will be adjusted to 3 L.min-1, and after closing the expiratory valve the airway pressure at which an audible leak in the mouth occurred will recorded as the 'Pleak'. When Pleak reach 35 cm H2O, expiratory valve will be opened.
Anatomical position of airway device will viewed by inserting fiberoptic bronchoscope through the ventilation tube.
Complications encountered during and at the end of the operation such as desaturation (sPO2 less than 90%), gastric insufflation, aspiration, laryngospasm, bronchospasm and blood stain on the airway device during removal will be recorded.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I-gel | Experimental | Device: I-gelI-gel (Intersurgical Ltd, Wokingham, Berkshire, UK) is a disposable supraglottic airway device with a non-inflatable cuff in which part of that is fixed on glottis is made of thermoplastic elastomer, unlike other laryngeal masks |
| ProSeal Laryngeal mask | Active comparator | Device: ProSeal Laryngeal maskProSeal laryngeal mask (PLMA) (LMA North America, Inc., San Diego, USA) is a modified type of LMA (larger and deeper bowl and enlarged and softer cuff) with gastric drainage tube. |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants and neonates, that to be used supraglottic airway and that plan to be taken elective surgery
Key exclusion criteria (1 listed)
- Infants having a history of pulmonary disease and expect to have aspiration (gastroesophageal reflux, gastrointestinal stenosis or stricture) and a 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 |
|---|---|---|
| I-gelSupraglottic airway device | Device | I-gel |
| ProSeal Laryngeal maskAlso: PLMASupraglottic airway device | Device | ProSeal Laryngeal mask |
Primary outcome
Airway leak pressure
Time frame: 1 year (After anesthesia induction)
Fresh gas flow will adjust to 3 L.min-1, and after closing the expiratory valve the airway pressure at which an audible leak in the mouth occurred will be recorded as the 'Pleak'.
4 secondary outcomes
Insertion time and conditions
Time frame: 1year (During maintainance of anesthesia)
Initial airway quality
Time frame: During maintainance of anesthesia
Evaluation of fiberoptic view
Time frame: 1 year (During maintainance of anesthesia)
Complications
Time frame: 1year(During maintainance of anesthesia)
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 11 Oct 2012.
- Derived from this study: PubMed 25793219Kayhan GE, Begec Z, Sanli M, Gedik E, Durmus M. Performance of size 1 I-gel compared with size 1 ProSeal laryngeal mask in anesthetized infants and neonates. ScientificWorldJournal. 2015;2015:426186. doi: 10.1155/2015/426186. Epub 2015 Feb 22.
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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.
Gulay Erdogan Kayhan study director
Assistant Professor, MD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I-gel and ProSeal Laryngeal mask in people with Laryngeal Masks, run by Inonu 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 1 inclusion and 1 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 11 Oct 2012. 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?
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 leak pressure (time frame: 1 year (After anesthesia induction)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01704118, which also lists 1 linked publication.
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 11 Oct 2012.