NCT05190757

Brief Summary

The purpose of this research is to compare if insertion of laryngeal mask airway (LMA) vs. use of face mask, will reduce the time needed to achieve adequate ventilation prior to insertion of the breathing tube.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2022

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

December 29, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 13, 2022

Completed
8 days until next milestone

Study Start

First participant enrolled

January 21, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2023

Completed
Last Updated

July 5, 2023

Status Verified

July 1, 2023

Enrollment Period

1.1 years

First QC Date

December 29, 2021

Last Update Submit

July 3, 2023

Conditions

Airway Complication of AnesthesiaDifficult or Failed Intubation

Outcome Measures

Primary Outcomes (1)

  • Successful ventilation

    Compare time needed to achieve ventilation

    Up to 15 minutes during the initial period of intubation.

Secondary Outcomes (1)

  • Subjective criteria of difficult ventilation and intubation

    Up to 30 minutes during the initial period of intubation

Study Arms (2)

Laryngeal Mask Airway

Other: Airway and Ventilation

Face Mask

Other: Airway and Ventilation

Interventions

Airway and VentilationOTHER

Insertion of Laryngeal Mask airway for ventilation or use of Face Mask

Face MaskLaryngeal Mask Airway

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients scheduled to undergo elective surgery

You may qualify if:

  • BMI ≥ 35.
  • Patients willing to participate and provide an informed consent.
  • Patients scheduled to undergo an elective surgical procedure including laparoscopic or robotic that requires GETA.

You may not qualify if:

  • Patients who require administration of succinylcholine for induction/intubation
  • Patients with history of uncontrolled GERD.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic Florida

Jacksonville, Florida, 32223, United States

Location

Related Links

MeSH Terms

Interventions

Ventilation

Intervention Hierarchy (Ancestors)

Environment, ControlledEnvironmentEnvironment and Public Health

Study Officials

  • Klaus Torp, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 29, 2021

First Posted

January 13, 2022

Study Start

January 21, 2022

Primary Completion

February 16, 2023

Study Completion

February 16, 2023

Last Updated

July 5, 2023

Record last verified: 2023-07

Locations

US(1)