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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT02026791
First received: December 18, 2013
Last updated: July 13, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
The Elderly Patients Aged Between 65 and 85
Device: I-gel
Device: Supreme-LMA

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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


Estimated Enrollment: 114
Study Start Date: December 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: The clinical efficacy of the I-gel
The clinical efficacy of the I-gel
Device: I-gel
  • 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.
Active Comparator: The clinical efficacy Supreme-LMA
The clinical efficacy Supreme-LMA
Device: Supreme-LMA
  • 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.

  Eligibility

Ages Eligible for Study:   65 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02026791

Contacts
Contact: Jae Hoon Lee, MD 82-2-2228-5782 neogens@yuhs.ac

Locations
Korea, Republic of
Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University Health System Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Jae Hoon Lee, MD    82-2-2228-5782    neogens@yuhs.ac   
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02026791     History of Changes
Other Study ID Numbers: 4-2013-0723
Study First Received: December 18, 2013
Last Updated: July 13, 2014
Health Authority: Korea: Institutional Review Board (Severance Hospital)

Keywords provided by Yonsei University:
Supraglottic airway device
I-gel
SupremeLMA
Elderly patient

ClinicalTrials.gov processed this record on November 24, 2014