Comparison of Size 1 I-gel and ProSeal Laryngeal Mask

NCT ID: NCT01704118

Last Updated: 2012-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2012-10-31

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.

Conditions

Laryngeal Masks

Keywords

I-gel; ProSeal laryngeal mask; small infants; neonates

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

I-gel

Intervention Type: DEVICE

Supraglottic airway device

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.

Group Type: ACTIVE_COMPARATOR

ProSeal Laryngeal mask

Intervention Type: DEVICE

Supraglottic airway device

Interventions

I-gel

Supraglottic airway device

Intervention Type: DEVICE

ProSeal Laryngeal mask

Supraglottic airway device

Intervention Type: DEVICE

Other Intervention Names

PLMA

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

• Maximum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Inonu University

OTHER

Sponsor Role: lead

Responsible Party

Gulay ERDOGAN KAYHAN

Assistant Prof,MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gulay Erdogan Kayhan

Role: STUDY_DIRECTOR

Assistant Professor, MD

Locations

Inonu University Turgut Ozal Medical Center

Malatya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: DERIVED

PMID: 25793219 (View on PubMed)

Other Identifiers

Inonu University

Identifier Type: -

Identifier Source: org_study_id