Comparison of Size 1 I-gel and ProSeal Laryngeal Mask

NCT01704118 | Completed DMC

• 1 other identifier: Inonu University
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Laryngeal Masks

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Insertion time and conditions

  1year (During maintainance of anesthesia)

• Initial airway quality

  During maintainance of anesthesia

• Evaluation of fiberoptic view

  1 year (During maintainance of anesthesia)

• Complications

  1year(During maintainance of anesthesia)

Study Arms (2)

I-gel

EXPERIMENTAL

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

ProSeal Laryngeal mask

ACTIVE COMPARATOR

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

Interventions

I-gel DEVICE

Supraglottic airway device

I-gel

ProSeal Laryngeal mask DEVICE

Supraglottic airway device

Also known as: PLMA

ProSeal Laryngeal mask

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Inonu University Turgut Ozal Medical Center

Malatya, 44315, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 25793219 DERIVED

Study Officials

• Gulay Erdogan Kayhan

  Assistant Professor, MD

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Prof,MD

Study Record Dates

• First Submitted: October 4, 2012
• First Posted: October 11, 2012
• Study Start: January 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: October 1, 2012
• Last Updated: October 11, 2012

Record last verified: 2012-10

Locations

TU (1)