Airway Complication of AnesthesiaNCT05190757
Supraglottic Airway Needed To Achieve Ventilation
An observational study of Airway Complication of Anesthesia and Difficult or Failed Intubation, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Airway Complication of Anesthesia, Difficult or Failed Intubation
- What is being tested?
- Airway and Ventilation
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2022to 16 Feb 2023
- Phase
- Observational
- 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
Study population: Patients scheduled to undergo elective surgery
Who may be able to join
- 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.
Who cannot join
- Patients who require administration of succinylcholine for induction/intubation
- Patients with history of uncontrolled GERD.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Airway and Ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airway and VentilationOther
Insertion of Laryngeal Mask airway for ventilation or use of Face Mask
| Study group | Role | What they receive |
|---|---|---|
| Laryngeal Mask Airway | Not described Receives: Other: Airway and Ventilation | |
| Face Mask | Not described Receives: Other: Airway and Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful ventilation
Compare time needed to achieve ventilation
Measured: Up to 15 minutes during the initial period of intubation.
Secondary outcomes (1)
Subjective criteria of difficult ventilation and intubation
Measured: Up to 30 minutes during the initial period of intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start21 Jan 2022
- Primary completion16 Feb 2023
- Study completion16 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway Complication of AnesthesiaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klaus D. Torp, Mayo Clinic
- Investigators
- Klaus Torp, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05190757
- Sponsor's protocol ID
- 21-008655
- Status last verified
- Jul 2023
- First submitted
- 29 Dec 2021
- Last updated
- 5 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supraglottic Airway Needed To Achieve Ventilation (SANTA)
- ClinicalTrials.gov ID
- NCT05190757
- Acronym / sponsor ID
- 21-008655
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 21 Jan 2022 (actual)
- Primary completion
- 16 Feb 2023 (actual)
- Study completion
- 16 Feb 2023 (actual)
- First posted
- 13 Jan 2022 (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 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laryngeal Mask Airway | – | Other: Airway and Ventilation |
| Face Mask | – | Other: Airway and Ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled to undergo elective surgery
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients who require administration of succinylcholine for induction/intubation
- Patients with history of uncontrolled GERD.
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 |
|---|---|---|
| Airway and VentilationInsertion of Laryngeal Mask airway for ventilation or use of Face Mask | Other | Face Mask, Laryngeal Mask Airway |
Primary outcome
Successful ventilation
Time frame: Up to 15 minutes during the initial period of intubation.
Compare time needed to achieve ventilation
1 secondary outcome
Subjective criteria of difficult ventilation and intubation
Time frame: Up to 30 minutes during the initial period of intubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Klaus Torp, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Airway Complication of Anesthesia and Difficult or Failed Intubation, run by Mayo Clinic at 1 site in United States.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 5 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Successful ventilation (time frame: Up to 15 minutes during the initial period of intubation.). 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 5 Jul 2023.