GMA-Tulip, I-gel and the LMA-Supreme (LMA-S) Devices in Airway Management (GLAM-I)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

498 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-30

Study Completion Date

2025-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Patients were randomly assigned to three supraglottic airway devices (SADs) groups for airway management after anesthesia induced. Fiberoptic bronchoscope (FB) guided glottic exposure grading was performed and other airway management quality was recorded.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

An in Vivo CT Imaging Study of GMA-Tulip, I-gel, and LMA Supreme (GLAM-II)

NCT07196696

Supraglottic Airway Device

RECRUITING NA

New-Generation GMA Laryngeal Mask Airway Versus Conventional Inflatable Laryngeal Mask Airway

NCT07177586

Supraglottic Airway Devices Position

RECRUITING NA

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

NCT06527352

Anesthesia

COMPLETED NA

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

NCT07019961

Trauma Surgery General Anesthesia

NOT_YET_RECRUITING NA

Fibre-optic Guided Tracheal Intubation Through SADs

NCT03118596

Intubation; Difficult or Failed Laryngeal Masks Airway Management

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Mechanical ventilation was volume controlled and time cycled with tidal volumes (6-8 ml/kg) set to maintain peak inspiratory pressures of less than 20 cm H2O and ventilatory frequency adjusted to maintain end-tidal carbon dioxide (PETCO2) at 35-45 mmHg. Then a fiberoptic bronchoscope was passed through airway tube into the device to perform glottic exposure grading. Peak airway pressure, incidence of pharyngalgia, bleeding, hoarseness, and dysphagia were recorded.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anesthesia Airway Remodeling

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Participants, investigators, outcome assessor and statistician were blind to the study.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LMA Supreme group

Patient in LMA supreme group received device of LMA supreme for airway management (one of supraglottic airway device for airway management during general anesthesia)

Group Type ACTIVE_COMPARATOR

LMA supreme group

Intervention Type DEVICE

Patient in this group received LMA supreme (one of laryngeal airway management device) for airway management during general anesthesia

I-gel group

Patient in I-gel group group received device of I-gel for airway management (one of supraglottic airway device for airway management during general anesthesia)

Group Type ACTIVE_COMPARATOR

I-gel group

Intervention Type DEVICE

Patient in this group received I-gel laryngeal (one of laryngeal airway management device) for airway management during general anesthesia

GMA-Tulip group

Patient in GMA-Tulip group group received device of GMA-Tulip for airway management (one of supraglottic airway device for airway management during general anesthesia)

Group Type EXPERIMENTAL

GMA-Tulip

Intervention Type DEVICE

Patient in this group received GMA-Tulip (one of laryngeal airway management device) for airway management during general anesthesia

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LMA supreme group

Patient in this group received LMA supreme (one of laryngeal airway management device) for airway management during general anesthesia

Intervention Type DEVICE

I-gel group

Patient in this group received I-gel laryngeal (one of laryngeal airway management device) for airway management during general anesthesia

Intervention Type DEVICE

GMA-Tulip

Patient in this group received GMA-Tulip (one of laryngeal airway management device) for airway management during general anesthesia

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 18-75 years old;
* American Society of Anesthesiologists (ASA) I-III;
* Body mass index (BMI)\<30Kg/m2;
* Scheduled for elective breast or lower abdominal surgery with an estimated duration of less than 4 hours;
* Providing written inform consent.

Exclusion Criteria

* History of oropharyngeal surgery and anatomical abnormalities;
* Limited movement of the cervical spine;
* High risk of reflux/aspiration;
* Emergency surgery;
* Acute throat inflammation and upper respiratory infection;
* History of chronic bronchitis or asthma;
* Cognitive dysfunction and inability to communicate;
* Participating in other clinical trials.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No