Comparison of Gastric Volume in I-gel and ProSeal Laryngeal Mask Airways

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-18

Study Completion Date

2025-10-10

Brief Summary

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This study was planned to compare the gastric insufflation volume between i jel and ProSeal laryngeal mask airway (LMA) and its relationship with the oropharyngeal sealing pressure and the incidence of postoperative complications in patients undergoing urological surgery.

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Detailed Description

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Supraglottic airway devices (SADs) are widely used in both elective and emergency surgeries, resuscitation, and difficult airway management. Compared to endotracheal intubation, they are less invasive, require lower doses of anaesthetic agents, and cause less haemodynamic instability. Among supraglottic airway devices, the I-gel differs from other SADs in that it does not have an inflatable cuff; instead, it features a soft structure made of a transparent thermoplastic elastomer that mimics a cuff. In addition, it has a gastric channel alongside the airway tube that allows for gastric aspiration.

ProSeal LMA is one of the most commonly used SADs in clinical practice. It was developed in the early 2000s as a modification of the classic LMA and includes an inflatable cuff. Like the I-gel, it also features a gastric drainage channel for aspiration.

Aspiration pneumonia is a serious complication of anaesthesia, accounting for approximately 9% of all anaesthesia-related mortality. Traditionally, oropharyngeal leak pressure (OLP) provides information about the potential for gastric insufflation and thus the risk of gastric aspiration. Measurement of the gastric antral cross-sectional area (AGCA) by ultrasound allows for the estimation of gastric volume and helps assess the risk of aspiration.

This study was planned to compare the gastric insufflation volume between i jel and ProSeal LMA and its relationship with the oropharyngeal sealing pressure and the incidence of postoperative complications in patients undergoing urological surgery.

Conditions

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Nausea and Vomiting, Postoperative Sore-throat

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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i jel group

under general anesthesia, patients inserted i jel LMA

Group Type EXPERIMENTAL

i jel LMA

Intervention Type OTHER

Patients will be inserted i jel laryngeal mask under general anesthesia.

proseal group

under general anesthesia, patients inserted proseal LMA.

Group Type EXPERIMENTAL

proseal LMA

Intervention Type OTHER

Patients will be inserted proseal laryngeal mask under general anesthesia.

Interventions

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i jel LMA

Patients will be inserted i jel laryngeal mask under general anesthesia.

Intervention Type OTHER

proseal LMA

Patients will be inserted proseal laryngeal mask under general anesthesia.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with an ASA (American Society of Anesthesiologists) physical status score of 1 to 3
* undergoing urological surgeries performed with I-gel or ProSeal LMA

Exclusion Criteria

* Difficult airway
* Clinically significant upper respiratory tract infection
* Pre-existing airway disease
* Pre-existing airway disease
* History of head and neck surgery
* Pregnant patients
* Patients with upper gastrointestinal tract disease

Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No