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NCT Number: NCT07138092

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

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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Key information

Conditions

Nausea and Vomiting, Postoperative Infections Nausea Otorhinolaryngologic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Pharyngitis Postoperative Complications Postoperative Nausea and Vomiting Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Digestive Sore-throat Stomatognathic Diseases Vomiting

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zeynep Koç

Yenimahalle, Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

i jel LMA

Other

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

proseal LMA

Other

Patients will be inserted proseal laryngeal mask under general anesthesia.

Primary outcomes

  1. Measurement of oropharyngeal leak pressure (OLP)

    Time frame: Five minutes after successful LMA placement

    One minute after successful LMA placement and fixation, oropharyngeal leak pressure (OLP) will be measured by setting the adjustable pressure limiting valve (APL) to 40 mmHg and maintaining a fresh gas flow of 3 L/min. The OLP will be recorded as the pressure at which an audible leak sound is heard from the mouth.

Secondary outcomes

  1. Gastric volume

    Time frame: 1 minute before induction of anesthesia

    Before induction of anesthesia, gastric ultrasonography will be performed by an experienced anaesthesiologist using a 2-5 MHz curved-array probe. The gastric antrum will be visualised in the sagittal plane in the epigastric region, located between the left lobe of the liver anteriorly, the aorta or inferior vena cava inferiorly, and the pancreas posteriorly.

    The gastric cross-sectional area (CSA) will be calculated using the following formula, assuming the antrum is elliptical: CSA = (A × B × π) / 4, where A is the anteroposterior diameter and B is the craniocaudal diameter. The estimated gastric volume will be calculated using a previously validated model for non-pregnant adults: Estimated gastric volume (mL) = 27 + (14.6 × ACSA [cm²]) - (1.28 × Age [years]).

  2. Gastric volume

    Time frame: End of the operation, 5 minutes before LMA removal,

    End of the operation,befeore LMA removal gastric ultrasonography will be performed by an experienced anaesthesiologist using a 2-5 MHz curved-array probe. The gastric antrum will be visualised in the sagittal plane in the epigastric region, located between the left lobe of the liver anteriorly, the aorta or inferior vena cava inferiorly, and the pancreas posteriorly.

    The gastric cross-sectional area (CSA) will be calculated using the following formula, assuming the antrum is elliptical: CSA = (A × B × π) / 4, where A is the anteroposterior diameter and B is the craniocaudal diameter. The estimated gastric volume will be calculated using a previously validated model for non-pregnant adults: Estimated gastric volume (mL) = 27 + (14.6 × ACSA [cm²]) - (1.28 × Age [years]).

  3. fiberoptic view grading

    Time frame: Five minutes after successful LMA placement

    The Brimacombe score will be used to evaluate the view obtained with fiberoptic bronchoscopy. 1: Vocal cords are not visible; 2: Vocal cords and anterior epiglottis are visible; 3: Vocal cords and posterior epiglottis are visible; 4: Vocal cords are visible.

  4. Complications during i jel and propseal LMA removal (emerge)

    Time frame: One minute after i jel and propseal LMA removal

    Complications during SP_Air-Q and proseal LMA removal (emerge) such as breath-holding during emergence, airway obstruction, coughing, hypoxia (SpO2 < 90%), vomiting, lip-tongue-teeth trauma, and bleeding, will be recorded.

Other outcomes

  1. sore throat

    Time frame: popstoperative 1. hour

    The presence or absence of sore throat will be recorded at the firsth postoperative hour.

  2. sore throat

    Time frame: popstoperative 24. hours

    The presence or absence of sore throat will be recorded at the firsth postoperative hour.

  3. dysphonia

    Time frame: popstoperative 1. hour

    The presence or absence of dysphonia will be recorded at the firsth postoperative hour.

  4. dysphonia

    Time frame: 24 hours postoperatively

    The presence or absence of dysphonia will be recorded at the 24th postoperative hour.

Study contacts

Contact information is provided by the study sponsor or research team.

Zeynep Koç

CONTACT

[email protected]

05345958843

Sponsors and collaborators

Lead sponsor

Diskapi Yildirim Beyazit Education and Research Hospital

Other Gov

Registry information

Official study title

Comparison of Gastric Insufflation Volume by Ultrasound Using I-gel and ProSeal Laryngeal Mask Airways in Patients Undergoing Urological Surgery

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 22, 2025
Registry last updated
Aug 22, 2025

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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