Supraglottic Airway Needed To Achieve Ventilation | NCT05190757

Studies
Supraglottic Airway Needed To Achieve Ventilation

NCT05190757

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

Jul 5, 2023Actual

Enrollment

54Actual

Phase

Not provided

Conditions

Airway Complication of Anesthesia
Difficult or Failed Intubation

Interventions

Airway and Ventilation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 21, 2022Actual

Primary Completion Date

Feb 16, 2023Actual

Completion Date

Feb 16, 2023Actual

First Submitted Date

Dec 29, 2021

First Submission Date that Met QC Criteria

Dec 29, 2021

First Posted Date

Jan 13, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 3, 2023

Last Update Posted Date

Jul 5, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

54Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Laryngeal Mask Airway			Other: Airway and Ventilation
Face Mask			Other: Airway and Ventilation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Airway and Ventilation	Other	Insertion of Laryngeal Mask airway for ventilation or use of Face Mask	Face Mask Laryngeal Mask Airway

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Successful ventilation	Compare time needed to achieve ventilation	Up to 15 minutes during the initial period of intubation.

Secondary Outcomes

Measure	Description	Time Frame
Subjective criteria of difficult ventilation and intubation		Up to 30 minutes during the initial period of intubation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients scheduled to undergo elective surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Klaus Torp, MD	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic Florida		Jacksonville	Florida	32223	United States

Label	URL
Mayo Clinic Clinical Trials	View source

Intervention Browse Module

MeSH Terms

ID	Term
D014691	Ventilation

Ancestor Terms

ID	Term
D004780	Environment, Controlled
D004777	Environment
D004778	Environment and Public Health

Browse Leaves

Not provided

Browse Branches

Not provided