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Completed

NCT Number: NCT01704118

Comparison of Size 1 I-gel and ProSeal Laryngeal Mask

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.

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Key information

Conditions

Laryngeal Masks

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inonu University Turgut Ozal Medical Center

Malatya, 44315, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

I-gel

Device

Supraglottic airway device

ProSeal Laryngeal mask

Device

Supraglottic airway device

Other names: PLMA

Primary outcomes

  1. Airway leak pressure

    Time frame: 1 year (After anesthesia induction)

    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'.

Secondary outcomes

  1. Insertion time and conditions

    Time frame: 1year (During maintainance of anesthesia)

    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).

  2. Initial airway quality

    Time frame: During maintainance of anesthesia

    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.

  3. Evaluation of fiberoptic view

    Time frame: 1 year (During maintainance of anesthesia)

    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.

  4. Complications

    Time frame: 1year(During maintainance of anesthesia)

    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.

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Registry information

Official study title

Is Size 1 I-gel More Effective Than Size 1 ProSeal Laryngeal Mask for Anesthetized Infants and Neonates?

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Oct 11, 2012
Registry last updated
Oct 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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