Trials Sponsors Conditions Drugs Pricing

Conditions

General Anesthesia Trauma Surgery

Keywords

GMA-TULIP laryngeal maski-gel laryngeal maskanatomical alignment of laryngeal maskoropharyngeal leak pressure

Outcome Measures

Primary Outcomes (1)

Accuracy of anatomical alignment under fiberoptic bronchoscopy observation
Class I: Vocal cords visible. Class II: Vocal cords and posterior epiglottis visible. Class III: Vocal cords and anterior epiglottis visible, \<50% visual obstruction of epiglottis to vocal cords. Class IV: Vocal cords and anterior epiglottis visible, \>50% visual obstruction of epiglottis to vocal cords. Class V: Vocal cords not visible. We define Class I and II field of view as accurate alignment; Class III and IV vision are defined as poor alignment; Class V vision is defined as alignment failure.
After insertion of laryngeal mask

Secondary Outcomes (13)

Number of laryngeal mask insertions
After anesthesia induction
Placement time of laryngeal mask
After anesthesia induction
Difficulty level of laryngeal mask insertion
After insertion of laryngeal mask
Time of insertion of gastric tube through laryngeal mask airway
After insertion of laryngeal mask
Number of gastric tube insertions
After insertion of laryngeal mask
+8 more secondary outcomes

Study Arms (2)

G group

EXPERIMENTAL

Participants who will use the GMA-TULIP laryngeal mask

Device: the GMA-TULIP laryngeal mask

I Group

ACTIVE COMPARATOR

Participants who will use the i-gel laryngeal mask

Device: the i-gel laryngeal mask

Interventions

the GMA-TULIP laryngeal maskDevice

insert GMA-TULIP laryngeal masks after anesthesia induction

G group

the i-gel laryngeal maskDevice

insert i-gel laryngeal masks after anesthesia induction

I Group

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Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

years old ≤ age ≤ 70 years old. Patients undergoing trauma surgery in a supine position under general anesthesia.
kg/m2 ≤ BMI ≤ 35 kg/m2. American Society of Anesthesiologists (ASA) grades I-III. Can understand the research process and the use of pain scales. Clear understanding and voluntary participation in the study, signing of informed consent form.

Sponsors & Collaborators

Qilu Hospital of Shandong University
Otherlead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Shaozhong Yang, DoctorCONTACT+86 18560083790 yszyang@163.com

Study Officials

Shaozhong Yang, Doctor
Qilu Hospital of Shandong University
STUDY CHAIR

Central Study Contacts

Shaozhong Yang, Doctor

CONTACT

+86 18560083790 yszyang@163.com

Study Design

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

Study Record Dates

First Submitted

June 5, 2025

First Posted

June 13, 2025

Study Start

July 1, 2025

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

December 1, 2025

Comparison of the GMA-TULIP and I-gel Laryngeal Mask for Airway Management in General Anaesthesia: a Randomized Controlled Trial

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (13)

Study Arms (2)

G group

I Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (13)

Study Arms (2)

G group

I Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations