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

Diskapi Yildirim Beyazit Training and Research Hospital

Status: Not yet enrolling

Conditions: Sore-throat; Nausea and Vomiting, Postoperative

Treatments: Other: proseal LMA; Other: i jel LMA

Study type: Interventional

Funder types: Other

Identifiers

NCT07138092

ZeynepKoc006

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

i jel group

Experimental group

Description:

under general anesthesia, patients inserted i jel LMA

Treatment:

Other: i jel LMA

proseal group

Experimental group

Description:

under general anesthesia, patients inserted proseal LMA.

Treatment:

Other: proseal LMA