NCT06383494

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
498

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 25, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

April 30, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

January 8, 2026

Status Verified

January 1, 2026

Enrollment Period

8 months

First QC Date

April 22, 2024

Last Update Submit

January 5, 2026

Conditions

AnesthesiaAirway Remodeling

Keywords

Supraglottic airway deviceLaryngeal inlet encapsulationLMA-Supremei-gelFiberoptic alignmentOptimal anatomical position

Outcome Measures

Primary Outcomes (1)

  • Glottic exposure grading

    Fiberoptic bronchoscope (FB) guided glottic exposure grading was performed.

    From the insertion of supraglottic airway device to the end of surgery.

Secondary Outcomes (16)

  • Peak inspiratory pressures

    From the insertion of supraglottic airway device to 15 minutes after insertion.

  • Plateau inspiratory pressures

    From the insertion of supraglottic airway device to 15 minutes after insertion.

  • Oropharyngeal leak pressure

    From the insertion of supraglottic airway device to 30 minutes after insertion

  • Oropharyngeal leak pressure at 30 and 45 degrees of head rotation

    From the insertion of supraglottic airway device to 30 minutes after insertion

  • Ventilation quality

    From the insertion of supraglottic airway device to 15 minutes after insertion

  • +11 more secondary outcomes

Study Arms (3)

LMA Supreme group

ACTIVE COMPARATOR

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

Device: LMA supreme group

I-gel group

ACTIVE COMPARATOR

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)

Device: I-gel group

GMA-Tulip group

EXPERIMENTAL

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)

Device: GMA-Tulip

Interventions

LMA supreme groupDEVICE

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

LMA Supreme group
I-gel groupDEVICE

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

I-gel group
GMA-TulipDEVICE

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

GMA-Tulip group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

MeSH Terms

Conditions

Airway Remodeling

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Jiangling Wang, Ph. D

    Zhejiang Cancer Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participants, investigators, outcome assessor and statistician were blind to the study.
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 22, 2024

First Posted

April 25, 2024

Study Start

April 30, 2024

Primary Completion

December 31, 2024

Study Completion

January 1, 2025

Last Updated

January 8, 2026

Record last verified: 2026-01

Locations

CN(1)