Comparison of Gastric Volume in I-gel and ProSeal Laryngeal Mask Airways
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: i jel LMA, proseal LMA.
- Who it may be relevant to
- Registry conditions: Nausea and Vomiting, Postoperative, Sore-throat. Basic parameters: 18 years — 79 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Gastric Insufflation Volume by Ultrasound Using I-gel and ProSeal Laryngeal Mask Airways in Patients Undergoing Urological Surgery
Overview
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.
Detailed 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.
Interventions
- Other i jel LMA
Patients will be inserted i jel laryngeal mask under general anesthesia. - Other proseal LMA
Patients will be inserted proseal laryngeal mask under general anesthesia.
Primary outcome measures
- Measurement of oropharyngeal leak pressure (OLP) [Time frame: Five minutes after successful LMA placement]
Secondary outcome measures (4)
- Gastric volume [Time frame: 1 minute before induction of anesthesia]
- Gastric volume [Time frame: End of the operation, 5 minutes before LMA removal,]
- fiberoptic view grading [Time frame: Five minutes after successful LMA placement]
- Complications during i jel and propseal LMA removal (emerge) [Time frame: One minute after i jel and propseal LMA removal]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 1 center
- Zeynep Koç — Yenimahalle
Publications
- Gunasekaran A, Govindaraj K, Gupta SL, Vinayagam S, Mishra SK. Comparison of Gastric Insufflation Volume Between Ambu AuraGain and ProSeal Laryngeal Mask Airway Using Ultrasonography in Patients Undergoing General Anesthesia: A Randomized Controlled Trial. Cureus. 2022 Aug 11;14(8):e27888. doi: 10.7759/cureus.27888. eCollection 2022 Aug. PMID 36110490
- Zhou S, Cao X, Zhou Y, Xu Z, Liu Z. Ultrasound Assessment of Gastric Volume in Parturients After High-Flow Nasal Oxygen Therapy. Anesth Analg. 2023 Jul 1;137(1):176-181. doi: 10.1213/ANE.0000000000006340. Epub 2023 Jan 11. PMID 36630297
- Ye Q, Wu D, Fang W, Wong GTC, Lu Y. Comparison of gastric insufflation using LMA-supreme and I-gel versus tracheal intubation in laparoscopic gynecological surgery by ultrasound: a randomized observational trial. BMC Anesthesiol. 2020 Jun 3;20(1):136. doi: 10.1186/s12871-020-01057-z. PMID 32493213
Identifiers
NCT: NCT07138092 · ZeynepKoc006