Supraglottic Airway Needed To Achieve Ventilation

• Sponsor: Mayo Clinic (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05190757
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Anticipated Duration (Months): 11.3
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Airway Complication of Anesthesia; Difficult or Failed Intubation	Other: Airway and Ventilation

Study Design

• Study Type: Observational
• Anticipated Enrollment: 10 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Supraglottic Airway Needed To Achieve Ventilation (SANTA)
• Actual Study Start Date: Jan 21, 2022
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Successful ventilation [Up to 15 minutes during the initial period of intubation.]

   Compare time needed to achieve ventilation

Secondary Outcome Measures

1. Subjective criteria of difficult ventilation and intubation [Up to 30 minutes during the initial period of intubation]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Florida	Jacksonville	Florida	United States	32223

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: Klaus Torp, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Klaus D. Torp, Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT05190757
• Other Study ID Numbers: 21-008655
• First Posted: Jan 13, 2022
• Last Update Posted: Mar 28, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Mar 28, 2022