Comparison of Size 1 I-gel and ProSeal Laryngeal Mask

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.

Study Overview

• Status: Completed
• Conditions: Laryngeal Masks
• Intervention / Treatment: Device: I-gel; Device: ProSeal Laryngeal mask

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Malatya, Turkey, 44315
    • Inonu University Turgut Ozal Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Infants and neonates, that to be used supraglottic airway and that plan to be taken elective surgery

Exclusion Criteria:

Infants having a history of pulmonary disease and expect to have aspiration (gastroesophageal reflux, gastrointestinal stenosis or stricture) and a difficult airway

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: I-gel; 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	Device: I-gel; Supraglottic airway device
Active Comparator: ProSeal Laryngeal mask; 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.	Device: ProSeal Laryngeal mask; Supraglottic airway device; Other Names: PLMA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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'.	1 year (After anesthesia induction)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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.	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.	1year(During maintainance of anesthesia)

Collaborators and Investigators

• Sponsor: Inonu University
• Investigators: Study Director: Gulay Erdogan Kayhan, Assistant Professor, MD

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: October 4, 2012
• First Submitted That Met QC Criteria: October 9, 2012
• First Posted (Estimate): October 11, 2012

Study Record Updates

• Last Update Posted (Estimate): October 11, 2012
• Last Update Submitted That Met QC Criteria: October 9, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: neonates; I-gel; ProSeal laryngeal mask; small infants
• Other Study ID Numbers: Inonu University (Inonu University)