Comparison of Size 1 I-gel and ProSeal Laryngeal Mask

Laryngeal Masks Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01704118
• Other study ID #: Inonu University
• Status: Completed
• Phase: N/A
• First received: October 4, 2012
• Last updated: October 9, 2012
• Start date: January 2012
• Est. completion date: October 2012

Study information

• Verified date: October 2012
• Source: Inonu University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 6 Months

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Laryngeal Masks

Intervention

Device:
• I-gel
Supraglottic airway device
• ProSeal Laryngeal mask
Supraglottic airway device

Locations

Country	Name	City	State
Turkey	Inonu University Turgut Ozal Medical Center	Malatya

Sponsors (1)

Lead Sponsor	Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No
Secondary	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	No
Secondary	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)	No
Secondary	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)	No