The Effects of GMA-TULIP, I-gel, and BlockBuster Laryngeal Mask in Surgeries With Lateral Position Under General Anesthesia

NCT06782841 | Recruiting

• 1 other identifier: 2024.134
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the efficacy and safety of traditional inflatable laryngeal mask, i-gel non-inflatable laryngeal mask and GMA-TULIP non-inflatable laryngeal mask in surgeries with lateral position under general anesthesia, so that providing evidence for the selection of laryngeal mask in surgeries with lateral position.

Conditions

Oropharyngeal Leak Pressure

Outcome Measures

Primary Outcomes (1)

• oropharyngeal leak pressure

  After the laryngeal mask is successful inserted, set the fresh gas flow to 3 L/min in manual mode, turn the APL valve to 30 cmH2O, then listen to the neck. When hearing the sound of air leakage, the peak airway pressure at this time is the oropharyngeal leak pressure.

  1 minute after the laryngeal mask is successful inserted, 5 and 30 minutes after the lateral position

Secondary Outcomes (24)

• The rate of first-insertion success

  1 minute after the first-attempt insertion of the laryngeal mask

• The rate of total-insertion success

  1 minute after the airway is successfully controlled.

• Time of insertion

  1 minute after successful insertion of the laryngeal mask

• Times of laryngeal mask adjustment before the successful insertion

  1 minute after the airway is successfully controlled.

• Success rate of gastric tube insertion through laryngeal mask

  1 minute after the laryngeal mask is successful inserted

Study Arms (3)

GMA-TULIP Laryngeal Mask Group（D1 Group）

EXPERIMENTAL

After the anesthesia induction, use the GMA-TULIP laryngeal mask as the airway ventilation device.

Device: GMA-TULIP Laryngeal Mask

i-gel Laryngeal Mask Group（D2 Group）

ACTIVE COMPARATOR

After the anesthesia induction, use the i-gel laryngeal mask as an airway ventilation device.

Device: i-gel Laryngeal Mask

BlockBuster Laryngeal Mask Group（D3 Group）

ACTIVE COMPARATOR

After the anesthesia induction is over, use the BlockBuster laryngeal mask as the airway ventilation device.

Device: BlockBuster Laryngeal Mask

Interventions

GMA-TULIP Laryngeal Mask DEVICE

After the anesthesia induction, use the GMA-TULIP laryngeal mask as the airway ventilation device.

GMA-TULIP Laryngeal Mask Group（D1 Group）

i-gel Laryngeal Mask DEVICE

After the anesthesia induction, use the i-gel laryngeal mask as an airway ventilation device.

i-gel Laryngeal Mask Group（D2 Group）

BlockBuster Laryngeal Mask DEVICE

After the anesthesia induction is over, use the BlockBuster laryngeal mask as the airway ventilation device.

BlockBuster Laryngeal Mask Group（D3 Group）

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients received surgeries in lateral position with an estimated surgery duration of less than 3 hours under general anesthesia.
• Ages between 18 to 80, and body mass index less than 28 kg/m².
• American Society of Anesthesiologists (ASA) Grades I-III.
• Patients are willing to participate and be able to understand and sign an informed consent form.

You may not qualify if:

• Individuals with an open bite of less than 2cm.
• Individuals with a history of obvious regurgitation of gastric contents and risk factors for aspiration.
• Patients with combined pharyngeal and laryngeal lesions.
• Predicting difficult airway patients.
• Hearing, intellectual, communication, and cognitive impairments.

Sponsors & Collaborators

• The Second Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400000, China

RECRUITING

Study Officials

• Bing Chen

  The Second Affiliated Hospital of Chongqing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bing Chen, PhD

CONTACT

+8617323832352; chenbing@cqmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2025
• First Posted: January 20, 2025
• Study Start: August 21, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 20, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will become available when publish and keep it for 5 years.
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

CN (1)