HypoxiaNCT07572500
MEA DPA Hypoxic Event Reductions
A study testing DPA and OPA in people with Hypoxia and OSA, run by Stanford University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- DPA and OPA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2025to Nov 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- History of diagnosed sleep apnea
- History of difficult intubation
- Prior need for two-handed mask ventilation
- Requiring general anesthesia with endotracheal intubation for surgery
Who cannot join
- Altered mental status
- Anesthesia technique includes rapid sequence or modified rapid sequence intubation
- Poorly controlled gastroesophageal reflux
About this study
Official title: Minimizing Deoxygenation Events During Anesthesia With a Novel Distal Pharyngeal Airway
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.
Read the detailed description
This prospective RCT will study adult patients who are determined to be at high risk for deoxygenation events during induction of general anesthesia. The study will randomize patients for use of a novel airway device (distal pharyngeal airway) versus standard oral pharyngeal airway during general anesthetic induction and measure differences in severity and duration of desaturation (hypoxic) events. The premise is the new novel device will reduce hypoxic events, improving patient safety and reducing airway complications. This is critically important as hypoxic events can have significant consequences. Providing a device that minimizes hypoxic events could impact patient safety positively. Additional measurements will include reduction in unanticipated patient admissions from airway complications with DPA use.
- Being tested
- DPA, OPA
- Keywords
- hypoxia, hypoxic, desaturation, deoxygenation, obstructive sleep apnea, obesity, mask ventilation, oral pharyngeal airway, distal pharyngeal airway, induction, difficult airway
- Medical subject headings
- Hypoxia, Obesity, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DPADevice
Anesthesiologist will use novel DPA device post anesthetic induction to assist in bag mask ventilation prior to endotracheal tube placement.
OPADevice
Anesthesiologist will use standard OPA device post anesthetic induction to assist in bag mask ventilation prior to endotracheal tube placement.
| Study group | Role | What they receive |
|---|---|---|
| Novel DPA device | Experimental | Assess duration and severity of deoxygenation events with DPA use during anesthetic induction and mask ventilation. Receives: Device: DPA |
| Standard OPA device | Active comparator | Assess duration and severity of deoxygenation events with OPA use during anesthetic induction and mask ventilation. Receives: Device: OPA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with clinically significant hypoxia SpO2 < 92
This outcome will be compared between two groups.
Measured: 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
Measured: 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
The number of supplemental airway interventions that the anesthesiologist must use to be able to ventilate the patient after the OPA or MEA DPA placement will be assessed. These supplemental interventions include chin lifts, jaw thrusts, head repositioning, and asking for additional aid when ventilating the patient. These notes will be compared and confirmed with the recorded induction footage from the cameras. Following data collection, data will be compared to demonstrate if there is a reduction in the need for manual intervention with the MEA DPA compared to a standard airway.
Measured: Post-treatment recorded intra-operatively (up to 24 hours)
Change in anesthesia provider satisfaction during anesthetic bag-mask ventilation (positive pressure ventilation)
Anesthesiologists will be asked if the MEA DPA is easier, harder, or has the same level of difficulty in placement and use as the standard OPA. Following data collection, the differences between the intervention and control group will be compared to demonstrate improved anesthesia provider satisfaction based on ease of placement, use and preferred future usage of MEA DPA.
Measured: Immediately post-operatively (up to 24 hours)
Incidence of obstruction for sedated patients arriving in postoperative care with an airway in situ
PACU nurse will indicate if the MEA DPA correlates with reduced post-operative care unit (PACU) airway manipulation (head repositioning, jaw thrust, increased oxygen flows). Following data collection, the differences between the intervention and control group will be compared to demonstrate preferred use through decreased airway management needs for PACU nurses with the DPA and reduced patient discomfort.
Measured: Immediately post-operatively (up to 24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study startNov 2025 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Why it stopped: Unable to secure funding for the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxiaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparison of two groups: 1) Oral pharyngeal airway (OPA) group 2) Distal pharyngeal airway (DPA) group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Louis Horn, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07572500
- Sponsor's protocol ID
- 73525
- Status last verified
- Apr 2026
- First submitted
- 24 Jan 2024
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimizing Deoxygenation Events During Anesthesia With a Novel Distal Pharyngeal Airway
- ClinicalTrials.gov ID
- NCT07572500
- Acronym / sponsor ID
- 73525
- Keywords
- hypoxia, hypoxic, desaturation, deoxygenation, obstructive sleep apnea, obesity, mask ventilation, oral pharyngeal airway
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to secure funding for the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Nov 2025 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 7 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This prospective RCT will study adult patients who are determined to be at high risk for deoxygenation events during induction of general anesthesia. The study will randomize patients for use of a novel airway device (distal pharyngeal airway) versus standard oral pharyngeal airway during general anesthetic induction and measure differences in severity and duration of desaturation (hypoxic) events. The premise is the new novel device will reduce hypoxic events, improving patient safety and reducing airway complications. This is critically important as hypoxic events can have significant consequences. Providing a device that minimizes hypoxic events could impact patient safety positively. Additional measurements will include reduction in unanticipated patient admissions from airway complications with DPA use.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Comparison of two groups: 1) Oral pharyngeal airway (OPA) group 2) Distal pharyngeal airway (DPA) group
| Arm | Type | Receives |
|---|---|---|
| Novel DPA device | Experimental | Device: DPAAssess duration and severity of deoxygenation events with DPA use during anesthetic induction and mask ventilation. |
| Standard OPA device | Active comparator | Device: OPAAssess duration and severity of deoxygenation events with OPA use during anesthetic induction and mask ventilation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (3 listed)
- Altered mental status
- Anesthesia technique includes rapid sequence or modified rapid sequence intubation
- Poorly controlled gastroesophageal reflux
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DPAAnesthesiologist will use novel DPA device post anesthetic induction to assist in bag mask ventilation prior to endotracheal tube placement. | Device | Novel DPA device |
| OPAAnesthesiologist will use standard OPA device post anesthetic induction to assist in bag mask ventilation prior to endotracheal tube placement. | Device | Standard OPA device |
Primary outcome
Number of participants with clinically significant hypoxia SpO2 < 92
Time frame: Post-treatment recorded intra-operatively (up to 24 hours)
This outcome will be compared between two groups.
4 secondary outcomes
Number of additional airway maneuvers used during bag-mask ventilation with the MEA DPA and OPA during induction of general anesthesia
Time frame: 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
Time frame: Post-treatment recorded intra-operatively (up to 24 hours)
Change in anesthesia provider satisfaction during anesthetic bag-mask ventilation (positive pressure ventilation)
Time frame: Immediately post-operatively (up to 24 hours)
Incidence of obstruction for sedated patients arriving in postoperative care with an airway in situ
Time frame: Immediately post-operatively (up to 24 hours)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing DPA and OPA in people with Hypoxia and OSA, run by Stanford University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with clinically significant hypoxia SpO2 < 92 (time frame: Post-treatment recorded intra-operatively (up to 24 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.