Risk of Gastric Reflux During Tulip vs GMA(Glottis Mask Airway) Airway

NCT06527352 | Completed

• 1 other identifier: XJH-A-20240708
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Glottis mask airway (GMA) is supraglottic airway device and is frequently used in patients undergoing general anesthesia. However, gastroesophageal reflux remains a risk during ventilation through supraglottic airway devices. The classical shaped GMA and tulip shaped GMA differ in the shape of their tips. And theoretically the tulip shaped tip fits the larynx better. This study aims to compare the incidence of gastroesophageal reflux during ventilation through classical shaped vs tulip shaped glottis mask airway.

Conditions

Anesthesia

Keywords

general anesthesia; glottis mask airway; Tulip shaped tip; gastroesophageal reflux

Outcome Measures

Primary Outcomes (1)

• pH value of secretion on the tip of glottis mask airway at the end of surgery

  at the end of surgery

Secondary Outcomes (11)

• number of participants with a pH value of secretion on the tip of glottis mask airway less than 4.1

  at the end of surgery

• Oropharyngeal leak pressure

  from insertion of glottis mask airway to start of surgery, at an average of 10 minutes

• duration of inserting glottis mask airway

  from taking of glottis mask airway to inserting it to appropriate position, at an average of 1 minute

• number of insertion to achieve successful positioning of glottis mask airway

  from taking of glottis mask airway to inserting it to appropriate position, at an average of 1 minute

• duration of establishing appropriate ventilation

  from taking of glottis mask airway to inserting it to appropriate position, at an average of 1 minute

Study Arms (2)

classical shaped mask airway

OTHER

Device: glottis mask airway; Other: classical shaped

tulip shaped mask airway

OTHER

Device: glottis mask airway; Other: tulip shaped

Interventions

glottis mask airway DEVICE

the glottis mask airway is used for maintaining ventilation during general anesthesia

classical shaped mask airway; tulip shaped mask airway

tulip shaped OTHER

the tulip shaped mask airway is with a tulip shaped tip

tulip shaped mask airway

classical shaped OTHER

the classical shaped mask airway is with a water-drop shaped tip

classical shaped mask airway

Eligibility Criteria

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

You may qualify if:

• age≥18 years old
• scheduled for surgery under general anesthesia with laryngeal mask airway

You may not qualify if:

• American society of anesthesiologists status score higher than 3
• morbid obesity (body mass index higher than 40 kg/m2)
• with high risk of gastroesophageal reflux
• with risk of difficult airway
• with airway disease

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (1)

Xijing Hospital, Air Force Medical University

Xi'an, Shaanxi, 710032, China

Location

Related Publications (4)

• Lemos J, De Oliveira GS Jr, de Pereira Cardoso HE, Lemos LD, de Carvalho LR, Modolo NS. Gastric regurgitation in patients undergoing gynecological laparoscopy with a laryngeal mask airway: a prospective observational study. J Clin Anesth. 2017 Feb;36:32-35. doi: 10.1016/j.jclinane.2016.07.038. Epub 2016 Nov 11.

  PMID: 28183569 BACKGROUND

• Nakanishi T, Sakamoto S, Yoshimura M, Toriumi T. AutoFlow(R) versus volume-controlled ventilation for laparoscopic gynecological surgery using LMA(R) ProSeal: a randomized controlled trial. BMC Anesthesiol. 2021 Jun 28;21(1):181. doi: 10.1186/s12871-021-01406-6.

  PMID: 34182933 BACKGROUND

• Liu Y, Song Y, Wang M, Yang M, Shen H, Wang Z, Chen L, Yang J, Gong S, Yu Y, Shi Z, Zhang W, Zou X, Sun X, Wang Y, Fu Q, Cao J, Mi W. LMA(R) protector in patients undergoing laparoscopic surgeries: a multicenter prospective observational study. BMC Anesthesiol. 2021 Dec 20;21(1):318. doi: 10.1186/s12871-021-01535-y.

  PMID: 34930137 RESULT

• Bhardwaj M, Dhania S, Kaur K, Lal J, Priya, Singhal SK. Comparison of oropharyngeal leak pressure of LMA Protector and LMA ProSeal in anaesthetised paralysed patients - A randomised controlled trial. Indian J Anaesth. 2023 Nov;67(Suppl 4):S245-S250. doi: 10.4103/ija.ija_403_23. Epub 2023 Nov 21.

  PMID: 38187973 RESULT

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: July 30, 2024
• Study Start: August 1, 2024
• Primary Completion: January 28, 2025
• Study Completion: January 29, 2025
• Last Updated: January 6, 2026

Record last verified: 2026-01

Locations

CN (1)