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I-Gel vs Ambu Laryngeal Mask Airways in Infants and Children Undergoing Surgical Procedures

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ClinicalTrials.gov Identifier: NCT02938039
Recruitment Status : Completed
First Posted : October 19, 2016
Last Update Posted : October 19, 2016
Sponsor:
Information provided by (Responsible Party):
Dr Abdulrahman Alzahem, King Saud University

Brief Summary:

This study will guide the anesthetists regarding the appropriate selection of the LMA in neonatal age group based on scientific basis.

This study will add up to existing literature about the safety of LMA usage in neonates and infants. Furthermore it may shed some light on which LMA type will be more feasible and effective for neonatal/ infants usage.


Condition or disease Intervention/treatment Phase
Laryngeal Masks Device: Ambu LMA Device: I-Gel LMA Not Applicable

Detailed Description:

Laryngeal mask airways (LMAs) are in practice of anesthesia since early 1980s. Pediatric and neonatal patients (including ex-premature) have also been benefited by the use of LMA. There are many advantages of LMA over endotracheal tube (ETT) in pediatric patients like ease of insertion, securing airway rapidly, avoidance of muscle relaxants, reduced incidence of sore throat, post operative hoarseness and coughing at the time of extubation, greater hemodynamic and intraocular pressure (IOP) stability. LMA has been recognized internationally in control of airway in difficult and failed intubation.

There are different types of pediatric LMAs available e.g. I-gel, ProSeal, LMA supreme, LMA classic, LMA unique, LarySeal and Ambu. These devices differ morphologically from each other (silicone, polyvinyl chloride or soft gel). There have been several randomized controlled studies comparing different LMAs in adults, however, the literature is sparse in which such comparison has been made in patients with weight 10 kg or below.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: I-Gel vs Ambu Laryngeal Mask Airways in Infants and Children Undergoing Surgical Procedures: A Randomized Clinical Trial
Study Start Date : May 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : October 2016

Arm Intervention/treatment
Active Comparator: Ambu LMA
Ambu Laryngeal Mask Airway device of different sizes for age
Device: Ambu LMA
Ambu Laryngeal Mask Airways

Active Comparator: I-Gel LMA
I-Gel Laryngeal Mask Airway device of different sizes for age
Device: I-Gel LMA
I-Gel Laryngeal Mask Airways




Primary Outcome Measures :
  1. Airway Leak Pressure [ Time Frame: 17 months ]
    It will be measured in mmHg unit and the expiratory valve will be closed with a fresh gas flow of 3 l.min-1 until an audible leak is heard, airway pressure will not be allowed to exceed 25 cmH2O), and then released completely


Secondary Outcome Measures :
  1. Effective airway time [ Time Frame: 18 months ]
    It will be measured in seconds unit , and The time for successful insertion will be measured from the moment the facemask will be removed until attainment of first capnography upstroke after insertion

  2. Ease of insertion [ Time Frame: 18 months ]
    The ease of placement of LMA will be assessed using a subjective scale of 1-4 (1 = no resistance and no maneuvers, 2 = mild resistance and one maneuver, 3 = moderate resistance and more than one maneuver, 4 = inability to place the device)

  3. Success at first attempt [ Time Frame: 18 months ]
    The insertion will be labelled as a 'failure' if the device could not be successfully placed within two attempts or lacked a square-wave capnograph tracing, or if there was airway obstruction (e.g. oxygen desaturation < 90%, abnormal thoraco-abdominal movements, or obstructive noises or no rise of chest at all), inadequate ventilation (an inability to deliver a minimum of 7 ml.kg-1 tidal volumes, or an audible leak)

  4. Oxygen Desaturation less than 90% [ Time Frame: 18 months ]
    It is a Yes or No outcome measure and it will be measured using the oxygen saturation monitor placed on finger and the reading will be detected on the capnography

  5. Gastric Insufflation [ Time Frame: 18 months ]
    It is a Yes or No outcome measure and auscultation with a stethoscope will be performed over the epigastrium during leak pressure testing to detect the occurrence of gastric insufflation

  6. Manipulation of the Device [ Time Frame: 18 months ]
    the number and type of airway manipulations (gentle advancement, withdrawal of device without removal, jaw thrust, or neck extension) required to maintain airway patency during the case will be recorded



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Ages Eligible for Study:   up to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elective surgical procedures
  • No muscle relaxant agents
  • No other comorbidities

Exclusion Criteria:

  • Emergency surgical procedures
  • Full stomach
  • Subjects with upper respiratory tract infection
  • Failed caudal block

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02938039


Sponsors and Collaborators
King Saud University
Investigators
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Principal Investigator: Abdulrahman M Alzahem, MD King Saud University

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Responsible Party: Dr Abdulrahman Alzahem, Associate Professor and Consultant, King Saud University
ClinicalTrials.gov Identifier: NCT02938039     History of Changes
Other Study ID Numbers: E14-1153
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: October 19, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Dr Abdulrahman Alzahem, King Saud University:
laryngeal airways
infants
neonates
children
anesthetized