MEA DPA Hypoxic Event Reductions

NCT07572500 | Withdrawn FDA Device

• 1 other identifier: 73525
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of the study is to compare deoxygenation events during anesthesia induction and mask ventilation when using standard oral pharyngeal airways or the novel distal pharyngeal airway.

Conditions

Hypoxia; OSA; Obesity

Keywords

hypoxia; hypoxic; desaturation; deoxygenation; obstructive sleep apnea; obesity; mask ventilation; oral pharyngeal airway; distal pharyngeal airway; induction; difficult airway

Outcome Measures

Primary Outcomes (1)

• Number of participants with clinically significant hypoxia SpO2 < 92

  This outcome will be compared between two groups.

  Post-treatment recorded intra-operatively (up to 24 hours)

Secondary Outcomes (4)

• Number of additional airway maneuvers used during bag-mask ventilation with the MEA DPA and OPA during induction of general anesthesia

  Post-treatment recorded intra-operatively (up to 24 hours)

• Determine if additional airway maneuvers are used during bag-mask ventilation with the MEA DPA and OPA during induction of general anesthesia

  Post-treatment recorded intra-operatively (up to 24 hours)

• Change in anesthesia provider satisfaction during anesthetic bag-mask ventilation (positive pressure ventilation)

  Immediately post-operatively (up to 24 hours)

• Incidence of obstruction for sedated patients arriving in postoperative care with an airway in situ

  Immediately post-operatively (up to 24 hours)

Study Arms (2)

Novel DPA device

EXPERIMENTAL

Assess duration and severity of deoxygenation events with DPA use during anesthetic induction and mask ventilation.

Device: DPA

Standard OPA device

ACTIVE COMPARATOR

Assess duration and severity of deoxygenation events with OPA use during anesthetic induction and mask ventilation.

Device: OPA

Interventions

DPA DEVICE

Anesthesiologist will use novel DPA device post anesthetic induction to assist in bag mask ventilation prior to endotracheal tube placement.

Novel DPA device

OPA DEVICE

Anesthesiologist will use standard OPA device post anesthetic induction to assist in bag mask ventilation prior to endotracheal tube placement.

Standard OPA device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient presenting for surgery at main Stanford Hospital
• Over 18 years old
• ASA Class II, III, IV
• High risk for hypoxic events during intubation based on their past medical history
• BMI \>35
• Likelihood of obstructive sleep apnea utilizing the STOP-BANG questionnaire
• History of diagnosed sleep apnea
• History of difficult intubation
• Prior need for two-handed mask ventilation
• Requiring general anesthesia with endotracheal intubation for surgery

You may not qualify if:

• Altered mental status
• Anesthesia technique includes rapid sequence or modified rapid sequence intubation
• Poorly controlled gastroesophageal reflux

Sponsors & Collaborators

• Stanford University: lead

MeSH Terms

Conditions

Hypoxia; Obesity; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology, Perioperative and Pain Medicine

Model Details: Comparison of two groups: 1) Oral pharyngeal airway (OPA) group 2) Distal pharyngeal airway (DPA) group

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: May 7, 2026
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share