Clinical trial NCT01704118: Comparison of Size 1 I-gel and ProSeal Laryngeal Mask
Official title: Is Size 1 I-gel More Effective Than Size 1 ProSeal Laryngeal Mask for Anesthetized Infants and Neonates?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laryngeal Masks
Keywords: I-gel
ProSeal laryngeal mask
small infants
neonates
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2012-10-11
Enrollment: 50
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Airway leak pressure
timeFrame: 1 year (After anesthesia induction)
Secondary outcomes:
measure: Insertion time and conditions
timeFrame: 1year (During maintainance of anesthesia)
measure: Initial airway quality
timeFrame: During maintainance of anesthesia
measure: Evaluation of fiberoptic view
timeFrame: 1 year (During maintainance of anesthesia)
measure: Complications
timeFrame: 1year(During maintainance of anesthesia)
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Inonu University Turgut Ozal Medical Center
Study officials:
affiliation: Assistant Professor, MD
name: Gulay Erdogan Kayhan
role: STUDY_DIRECTOR
References:
citation: 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.