Supraglottic Airway Needed To Achieve Ventilation

Supraglottic Airway Needed To Achieve Ventilation (SANTA)

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.

Study Overview

• Status: Completed
• Conditions: Airway Complication of Anesthesia; Difficult or Failed Intubation
• Intervention / Treatment: Other: Airway and Ventilation

• Study Type: Observational
• Enrollment (Actual): 54

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32223
      • Mayo Clinic Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled to undergo elective surgery

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Laryngeal Mask Airway	Other: Airway and Ventilation; Insertion of Laryngeal Mask airway for ventilation or use of Face Mask
Face Mask	Other: Airway and Ventilation; Insertion of Laryngeal Mask airway for ventilation or use of Face Mask

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Klaus Torp, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2022
• Primary Completion (Actual): February 16, 2023
• Study Completion (Actual): February 16, 2023

Study Registration Dates

• First Submitted: December 29, 2021
• First Submitted That Met QC Criteria: December 29, 2021
• First Posted (Actual): January 13, 2022

Study Record Updates

• Last Update Posted (Actual): July 5, 2023
• Last Update Submitted That Met QC Criteria: July 3, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 21-008655

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No