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

NCT07138092 | Not Yet Recruiting

• 1 other identifier: ZeynepKoc006
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nausea and Vomiting, Postoperative; Sore-throat

Keywords

Gastric insufflation; Ultrasound; Supraglottic airway devices; Oropharyngeal leak pressure

Outcome Measures

Primary Outcomes (1)

• Measurement of oropharyngeal leak pressure (OLP)

  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.

  Five minutes after successful LMA placement

Secondary Outcomes (4)

• Gastric volume

  1 minute before induction of anesthesia

• Gastric volume

  End of the operation, 5 minutes before LMA removal,

• fiberoptic view grading

  Five minutes after successful LMA placement

• Complications during i jel and propseal LMA removal (emerge)

  One minute after i jel and propseal LMA removal

Other Outcomes (4)

• sore throat

  popstoperative 1. hour

• sore throat

  popstoperative 24. hours

• dysphonia

  popstoperative 1. hour

Study Arms (2)

i jel group

EXPERIMENTAL

under general anesthesia, patients inserted i jel LMA

Other: i jel LMA

proseal group

EXPERIMENTAL

under general anesthesia, patients inserted proseal LMA.

Other: proseal LMA

Interventions

i jel LMA OTHER

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

i jel group

proseal LMA OTHER

Patients will be inserted proseal laryngeal mask under general anesthesia.

proseal group

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Diskapi Yildirim Beyazit Education and Research Hospital: lead

Study Sites (1)

Zeynep Koç

Yenimahalle, Ankara, Turkey (Türkiye)

Location

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 RESULT

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Pharyngitis

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Zeynep Koç

CONTACT

05345958843; zeynepyilmazkoc@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: August 15, 2025
• First Posted: August 22, 2025
• Study Start: August 18, 2025
• Primary Completion: September 29, 2025
• Study Completion: October 10, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)