Application of I-gel Laryngeal Mask Airway in Pediatric Patients

August 27, 2020 updated by: Xian Children's Hospital

Application of I-gel Laryngeal Mask Airway in Infants and Children Undergoing Surgical Procedures

Background The laryngeal mask airway (LMA) is a supraglottic airway device ,which is commonly used to manage children's airways, because it is typically easy to use and can avoid problems specific to tracheal intubation. Since the LMA was introduced into clinical practice in 1988 , various types of LMAs have been developed, the safety and efficacy of which have been established in both adults and children.The paediatric i-gel is a relatively new and disposable supraglottic airway device for children, which is made of a soft gel-like elastomer with a non-inflatable cuff and a channel for gastric catheter placement . It does not require cuff inflation ,reducing the complications associated with compression trauma and high cuff pressure . Medical-grade thermoplastic elastomer creates a more intimate interface for interacting with supraglottic tissue. The usage of i-gel mask is more common in adults ,though a large scale study focusing on children is lacking.

Objectives:

To evaluate the efficacy and performance of the pediatric i-gel mask

Methods:

From November 2018 to March 2019, subjects are selected from patients who undergo elective surgery at Xi'an Children's Hospital, within the age of 0 to 108 months old, with an American Society of Anesthesiologists physical status I or II .They were assigned into four groups according to their weight. Four groups are : 2-5 kg (group 1#), 5.1-12.0 kg (group 1.5#), 10-25kg (group 2#) 25-35kg(group 2.5#). The primary outcome is the clinical performance of the airways: the rate of insertion at first attempt,the ease of insertion,the insertion time,the oropharyngeal leak pressure(OLP),the fibreoptic view and the ease of gastric tube insertion. The secondary outcome is the frequency of other perioperative complications as listed in the detail information section.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

methods This is a prospective, randomized, parallel-group, single sample study ,which was approved by the Ethics Committee of Children's Hospital affiliated to Xi'an Jiaotong University.The experiment is expected to be completed between December 2018 and March 2019 in Xi'an children's Hospital, signed consent will be obtained from the parents or the guardian of the child participating in the study.The inclusion criteria are: children aged between 0 to 108 months, Weighed between 2 to 35 kg,with an American Standards Association (ASA )physical status Ι or Ⅱ, who are scheduled for elective surgery shorter than four hours under general anesthesia . In addition,the operation of supraglottic airway devices needs to be seamless during perioperative period. Children with below condition will be excluded form the experiment:a suspected difficult airway, a history of upper respiratory tract infection two weeks before operation ,being at risk of aspiration (such as non-fasting status , gastroesophageal reflux disease and hiatus hernia),lung diseases, limited head-neck movements, and those refusing to participate.The children with symptoms bradycardia and conduction block shown on EEG are also excluded from this experiment.The children were assigned into four groups based on their weights : size 1 for 2-5kg ,size 1.5 for 5-12 kg, size 2 for 10-25 kg, size 2.5 for 25-35 kg . The required device is prepared according to the child's weight and using the the manufacturer's guidelines . The children's group allocation were operated by a researcher who do not participate in post anesthesia care unit or outcome assessment. All children involved in the experiment, the children's parents, and the data analyzer are blind to the device used. In preparation for surgery,children are fasted 8h from solid food with fat content, 6h from semi-solid food and liquid food ,4h for breast milk and 2 h for clear water .Premedication is provided about 20 minutes before entering the operating room, by which children receive intranasal dexmedetomidine 1.5ug/kg, so that children can enter the operating room quietly. On arrival in the operating room, children were monitored using pulse oximetry, electrocardiography, non-invasive blood pressure, and capnography. General anaesthesia was induced with 100% oxygen 2-4 Liter(L)/min. Injection atropine 0.01mg/kg、fentanyl 2 μg/kg 、 propofol 2mg/kg 、vecuronium bromide 0.1 mg/kg intravenously (IV) in turn.After loss of consciousness, children are promptly positioned supine with an adequate sized roll underneath the neck to establish optimal position.Achieving appropriate anesthesia depth,children are randomised to have inserted i-gel ,The jaw thrust maneuver are used to confirm anesthesia depth whether it is suitable for placing the laryngeal mask and facilitating its placement. We do not administer neuromuscular blocking during intraoperative period. Two anesthesiologists came to the hospital for working at least one year and experienced in inserting supraglottic airway devices in at least 200 pediatric patients. The device was inserted according to the manufacturer's recommendations .Device insertion was considered successful by observing bilateral chest wall movement,as well as a stable square-wave capnogram trace ,the lung breath sound with no audible leak .Three failed insertion attempts are considered failed insertion of the device, and patients were withdrawn from the study.Tracheal intubation was considered after failure of three times of laryngeal mask airway placement.

Insertion time was measured from the moment a device was picked up until confirmation of the first wave on a capnogram，The ease of device placement was assessed using a subjective grading score of 1-4 (1: no resistance, 2: mild resistance, 3: moderate resistance, 4: inability to place the device) by the anesthesiologist. We also record the manipulations for improving device position, such as adjusting the insertion depth, conducting a jaw thrust maneuver, or flexion/extension of the head.

Oropharyngeal leak pressure and fiberoptic view through the device were assessed. Oropharyngeal leak pressure was determined by closing the adjustable pressure-limiting valve to 30 centimeter water column(cmH 2 O) at the fresh gas flow rate of 3 L/min, switching the mechanical ventilation to manual ventilation, and reading the airway pressure on the monitor in the anesthesia machine which an audible leak on auscultation over neck was defined as OLP. The OLP was not allowed to exceed 30 cmH 2 O to avoid barotrauma, If mean airway pressure is higher than OLP or insufficient ventilation (lesser than 5 ml/kg) occurred during the airway maintenance, proper manipulations (pushing or pulling of device, extension or flexion of the head, jaw thrust) were performed. If appropriate manipulation does not solve the problem, the device should be removed and endotracheal intubation be performed. The anatomical position of the LMA in relation to the glottis was evaluated by placing a fiberoptic bronchoscope through the device .The fiberoptic view is classified into four grades by observing the fiberoptic views (grade 1: vocal cords not visible, grade 2: vocal cords and anterior epiglottis visible, grade 3: vocal cords and posterior epiglottis visible, grade 4: only vocal cords visible). The 8-12 French size gastric tubes are used for those groups. A well-lubricated gastric tube is prepared before inserted into the stomach through gastric port of airway device. The assessment of correct placement is through detection of injected air by epigastric auscultation or by aspiration of gastric content .A grading scale(1:easy,2:difficult,3：failure) is used for assessing the ease of gastric tube insertion.Easy is defined as placing the tube successfully in the first attempt,difficult is defined as placing the tube successfully within two attempts, failure is defined as inability to establish correct placement within three placements.Anesthesia was maintained using 2%~3% sevoflurane and remifentanil 0.2~0.4ug/kg•min.1 ug/kg fentanyl is added again before the skin incision and suture. At the end of surgery, the anesthetics are terminated. The patient was then moved to the postanesthesia care unit (PACU).We recorded heart rate, mean blood pressure, oxygen saturation, peak inspiratory pressure and complications during the induction and maintenance of anesthesia. At the conclusion of the surgery, when the tidal volume is >6 ml/kg or end-tidal carbon dioxide(CO2) is less than 50 mmHg,we can stop the mechanical ventilation and keep the patient's spontaneous respiration. The LMA is removed when evidence of adequate emergence including spontaneous eye opening, grimacing using forehead and/or eyebrow, and purposeful movement. In addition,we also observed the complication such as coughing, bronchospasm, laryngospasm, desaturation (SpO 2 < 90%), regurgitation, aspiration, sore throat, blood-on LMA, postoperative nausea and vomiting (PONV), breath-holding and teeth or lip injury during anesthesia maintenance and emergence . A blinded investigator assessed all patients in the PACU and conducted a ward visit or telephone interview 24 h after the end of surgery. In our study, the primary outcome is oropharyngeal leak pressure，the secondary outcome are the rate of successful insertion at first attempt, fiberoptic view，insertion time，ease of insertion，ease of gastric tube insertion。 We recorded complications including coughing, breath-holding, desaturation, laryngospasm or bronchospasm，blood-on LMA, sore throat, postoperative nausea and vomiting (PONV), regurgitation, aspiration, teeth or lip injury.

Study Type

Interventional

Enrollment (Actual)

413

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710000
        • Xi'an Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 9 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Weight between 2 to 35 kg ASA physical status Ι or Ⅱ elective surgery operation time not longer than four hours general anesthesia

Exclusion Criteria:

  • a history of upper respiratory tract infection two weeks before operation risk of aspiration (such as non-fasting status , gastroesophageal reflux disease and hiatus hernia) lung diseases limited head-neck movements those refusing to participate children whose EEG showing bradycardia and conduction block

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: airway type 1
The children weighed between 2-5kg are assigned into this group,they are allocated with i-gel laryngeal mask airway type 1
Device: laryngeal mask airway
i-gel laryngeal mask airway is a supraglottic airway device made from a medical grade thermoplastic elastomer , is a non-inflatable device to create anatomical seal of the pharyngeal, laryngeal and perilaryngeal structures and avoid compression trauma.
Other Names:
  • i-gel
Experimental: airway type 1.5
The children weighed between 5-12kg are assigned into this group,they are allocated with i-gel laryngeal mask airway type 1.5
Device: laryngeal mask airway
i-gel laryngeal mask airway is a supraglottic airway device made from a medical grade thermoplastic elastomer , is a non-inflatable device to create anatomical seal of the pharyngeal, laryngeal and perilaryngeal structures and avoid compression trauma.
Other Names:
  • i-gel
Experimental: airway type 2
The children weighed between 10-25kg are assigned into this group,they are allocated with i-gel laryngeal mask airway type 2
Device: laryngeal mask airway
i-gel laryngeal mask airway is a supraglottic airway device made from a medical grade thermoplastic elastomer , is a non-inflatable device to create anatomical seal of the pharyngeal, laryngeal and perilaryngeal structures and avoid compression trauma.
Other Names:
  • i-gel
Experimental: airway type 2.5
The children weighed between 25-35kg are assigned into this group,they are allocated with i-gel laryngeal mask airway type 2.5
Device: laryngeal mask airway
i-gel laryngeal mask airway is a supraglottic airway device made from a medical grade thermoplastic elastomer , is a non-inflatable device to create anatomical seal of the pharyngeal, laryngeal and perilaryngeal structures and avoid compression trauma.
Other Names:
  • i-gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oropharyngeal leak pressure
Time Frame: At 5 min after the insertion of i-gel protector
reading the airway pressure on the monitor in the anesthesia machine
At 5 min after the insertion of i-gel protector

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
insertion time
Time Frame: During the insertion of i-gel protector
insertion time is measured from the moment of picking up the device to confirming the first the appearance of the ETCO2 on monitor screen
During the insertion of i-gel protector
ease of insertion
Time Frame: during the insertion of i-gel protector
Ease of insertion we are using a subjective grading score of 1-4 (1: requiring no additional maneuver, 2:requiring 1 additional maneuver, 3:requiring 2 additional maneuver, 4: requiring more than 3 maneuver)
during the insertion of i-gel protector
fiberoptic view
Time Frame: At 15 min after the insertion of i-gel protector
After insertion of the device, observe the accuracy of insertion location by the fiberoptic views through the device(grade 1: vocal cords not visible, grade 2: vocal cords and anterior epiglottis visible, grade 3: vocal cords and posterior epiglottis visible, grade 4: only vocal cords visible)
At 15 min after the insertion of i-gel protector
the rate of successful insertion at first attempt
Time Frame: During the first attempt insertion of i-gel protector
the insertion is successful at first attempt
During the first attempt insertion of i-gel protector
the ease of gastric tube insertion
Time Frame: At 25 min after the insertion of i-gel protector
subjective grading scale(1:easy，2:difficult,3:failed insertion) is used for assessing the ease of gastric tube insertion.Easy is defined as placing the tube successfully in the first attempt,difficult is defined as placing the tube successfully within two attempts, failure is defined as inability to establish correct placement within three placements.
At 25 min after the insertion of i-gel protector

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xian Children's Hospital

Investigators

  • Study Chair: fang li yang, doctor, Xian Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2018

Primary Completion (Actual)

September 30, 2019

Study Completion (Actual)

September 30, 2019

Study Registration Dates

First Submitted

October 24, 2018

First Submitted That Met QC Criteria

November 17, 2018

First Posted (Actual)

November 21, 2018

Study Record Updates

Last Update Posted (Actual)

August 31, 2020

Last Update Submitted That Met QC Criteria

August 27, 2020

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2018008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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