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The Elderly Patients Aged Between 65 and 85NCT02026791

The Comparison of the Clinical Efficacy Between I-gel and LMA-Supreme, the Two Most Recently Developed Supraglottic Airway Devices, in Elderly Patients

A study testing I-gel and Supreme-LMA in people with The Elderly Patients Aged Between 65 and 85, run by Yonsei University at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Since the laryngeal mask airway (LMA) was designed and introduced into a clinical setting, a supraglottic airway device is widely used because it has advantages such as manipulation of the device when inserting it is easier than that of an endotracheal tube and it causes less postoperative sore throats. Read more about this study

Who is it for?
Ages 65 to 85 yearsHealthy volunteers can take part
What is being tested?
I-gel and Supreme-LMA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
1 siteSouth Korea
Study dates
Dec 2013to Oct 2016
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 65 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • The elderly patients aged between 65 and 85
  • The patient having a plan for a regular operation under general anesthesia in which the expected operation duration is within two hours and the airway may be managed intraoperatively with a supraglottic airway device.

Who cannot join

  • The patients having an anatomical structure which may cause difficulty in mask respiration
  • The patients having an upper airway infection or an airway-related disease such as asthma and pneumonia.
  • The patients having a risk of aspiration such as gastroesophageal reflux.

Trial locations and contacts

1 site in 1 country.

South Korea1 site
  • Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University Health System

    Seoul, 120-752

Other trials in South Korea

About this study

Since the laryngeal mask airway (LMA) was designed and introduced into a clinical setting, a supraglottic airway device is widely used because it has advantages such as manipulation of the device when inserting it is easier than that of an endotracheal tube and it causes less postoperative sore throats. Insertion of an LMA can be performed relatively easily and safety at an appropriate depth of anesthesia when compared with the insertion of an endotracheal tube because an LMA is inserted without using a laryngoscope and without causing stimulus to the vocal cords and the trachea. Hence, an LMA may be useful in cases of coronary artery disease and a carotid endarectomy where stabilization of the cardiopulmonary function is important. In addition, an LMA is hemodynamically stable not only in the induction of anesthesia but also in the arousal of anesthesia and thus less dangerous to a cardiovascular disease patient. LMA may be useful also to patients having chronic obstructive lung disease because the patients have an excessively sensitive airway and ventilation is difficult to perform in them. Therefore, in elderly patients having a prevalence for cardiovascular disease or chronic obstructive lung disease, use of an LMA, which stimulates the airway less, may provide hemodynamical stability and reduce relevant complications or side effects. LMA Supreme which is newly designed in such ways has been proven to be superior to the conventional LMA Classic in terms of easy insertion and oropharyngeal sealing. A study which compared LMA Classic and LMA Supreme with adult subjects showed that LMA Supreme had a superior insertion success rate and better oropharyngeal leak pressure (OLP) than those of LMA Classic. Another newly developed supraglottic airway device is I-gel. In I-gel, which is a disposable, latex-free LMA, a soft, gel-type cuff made of a thermoplastic elastomer replaces the inflatable cuff of other LMAs. Thus, I-gel has an advantage that, once it is installed, it requires no additional clinical manipulation such as cuff inflation or cuff pressure monitoring. A comparison of I-gel with LMA Classic and other disposable supraglottic airway devices produced by various manufactures in adult subjects showed that the clinical properties were similar with respect to easy insertion, time required for installation, laryngopharynx leak pressure, and degree of glottis exposure observed with a fiberoptic bronchoscope. Thus, I-gel is expected to be a supraglottic airway device which may replace the conventional LMA Classic. The elderly are known to have an upper airway anatomically different from that of younger adults depending on age. A study conducted with CT showed that normal elderly people had a wider upper airway than that of younger males or middle-aged males and that elderly with accompanying sleep apnea had a wider upper airway than that of younger males in all regions including the nasopharynx, oropharynx, and hypopharynx. Therefore, because the upper airway of the elderly is wider and longer, a different supraglottic airway device guide may be necessary. Our previous studies showed that the single time success rate was significantly lower, the insertion was more difficult, and the insertion took a longer time when the LMA classic was used in elderly patients than in younger adult patients. However, there is no available guide for the use of a supraglottic airway device or for a supraglottic airway device more appropriate for elderly patients. Moreover, no study has been ever conducted with regard to such a guide.

Therefore, in this study, the clinical usefulness of I-gel and LMA Supreme, which are the newest supraglottic airway devices, was verified in elderly patients. It was also verified which of the two devices is better to use as a supraglottic airway device.

Being tested
I-gel, Supreme-LMA
Keywords
Supraglottic airway device, I-gel, SupremeLMA, Elderly patient

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • I-gelDevice

    • The patient was monitored at 1-5 minute intervals.
    • While supplying oxygen through a mask, propofol 1.0mg/kg and remifentanil 0.5ug/kg were intravenously injected to induce anesthesia. When consciousness was not lost, propofol 0.5mg/kg was additionally injected. After consciousness was lost and spontaneous respiration disappeared, rocuronium 0.3 mg/kg was intravenously injected while performing manual ventilation.
    • After injecting an anesthetic and muscle relaxant, the injection concentration of fresh gas including 6 L/min oxygen and desflurane was regulated to maintain BIS between 40 and 60. A train of four (TOF) was performed with a nerve stimulator for muscle relaxation monitoring to verify that a muscular contraction did not take place (TOF=0).
    • Then, with the assistance of another anesthesiologist, I-gel prepared in advance was inserted.
  • Supreme-LMADevice

    • The patient was monitored at 1-5 minute intervals.
    • While supplying oxygen through a mask, propofol 1.0mg/kg and remifentanil 0.5ug/kg were intravenously injected to induce anesthesia. When consciousness was not lost, propofol 0.5mg/kg was additionally injected. After consciousness was lost and spontaneous respiration disappeared, rocuronium 0.3 mg/kg was intravenously injected while performing manual ventilation.
    • After injecting an anesthetic and muscle relaxant, the injection concentration of fresh gas including 6 L/min oxygen and desflurane was regulated to maintain BIS between 40 and 60. A train of four (TOF) was performed with a nerve stimulator for muscle relaxation monitoring to verify that a muscular contraction did not take place (TOF=0).
    • Then, with the assistance of another anesthesiologist, Supreme LMA prepared in advance was inserted.
Study groups in NCT02026791
Study groupRoleWhat they receive
The clinical efficacy of the I-gelExperimentalThe clinical efficacy of the I-gel
Receives: Device: I-gel
The clinical efficacy Supreme-LMAActive comparatorThe clinical efficacy Supreme-LMA
Receives: Device: Supreme-LMA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The success insertion rate of supraglottic airway devices of the first trial was the primary end point.

    The success insertion rate of supraglottic airway devices of the first trial was the primary end point. In success insertion of supraglottic airway devices is confirmed by following cases of manual ventilation.

    1. Appropriateness of the chest wall movement
    2. A square wave in the capnograph
    3. The time taken until the successful installation of an LMA

    Measured: Average 10 seconds after induction and during average 10 mins

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jan 2014 (estimated)
  2. Study startDec 2013
  3. Primary completionOct 2016
  4. Study completionOct 2016

Resources

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
None (open label)
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02026791
Sponsor's protocol ID
4-2013-0723
Status last verified
Nov 2016
First submitted
18 Dec 2013
Last updated
3 Nov 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Kim MH, Lee JH, Choi YS, Park S, Shin S. Comparison of the laryngeal mask airway supreme and the i-gel in paralysed elderly patients: A randomised controlled trial. Eur J Anaesthesiol. 2018 Aug;35(8):598-604. doi: 10.1097/EJA.0000000000000700.

    PubMed 28857785

Questions about this trial

What is this clinical trial studying?

A study testing I-gel and Supreme-LMA in people with The Elderly Patients Aged Between 65 and 85, run by Yonsei University at 1 site in South Korea.

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 2 inclusion and 3 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 3 Nov 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 South Korea. 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?

The success insertion rate of supraglottic airway devices of the first trial was the primary end point. (time frame: Average 10 seconds after induction and during average 10 mins). 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 NCT02026791, 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 3 Nov 2016.

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