Airway ManagementNCT06117683
Non-inferiority Trial Between Sotair® Device Attached to Manual Resuscitator Versus Mechanical Ventilation
A study testing ADULT Sotair Device in people with Airway Management and Respiration, Artificial, run by Rhode Island Hospital at 1 site in United States.
Trial summary
Effective respiratory ventilation is achieved by moving the right amount of air in and out of the lungs while keeping the pressures at a safe level. A disposable safety device, Adult Sotair®, was created to improve manual ventilation delivery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Airway Management, Respiration, Artificial
- What is being tested?
- ADULT Sotair Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 334 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2023to 28 May 2025
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients who are scheduled for non-emergency surgery with general anesthesia at Rhode Island Hospital.
- American Society of Anesthesiologists physical status 1 and 2
Who cannot join
- ASA PS >3 (e.g., respiratory disease)
- Oropharyngeal or facial pathology
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
Official title: Non-inferiority Comparative Trial Between Sotair® Device Attached to Manual Resuscitator Versus Mechanical Ventilation in Patients Undergoing Non-emergent Surgery With General Anesthesia
Effective respiratory ventilation is achieved by moving the right amount of air in and out of the lungs while keeping the pressures at a safe level. A disposable safety device, Adult Sotair®, was created to improve manual ventilation delivery. In this non-inferiority study, we will perform a pre-post study design (single group, within-group comparison) to test the non-inferiority of the Adult Sotair® device compared to mechanical ventilation.
Read the detailed description
Poor manual ventilation technique is a well-documented problem which occurs irrespective of a provider's qualifications or experience. A disposable safety device, Adult Sotair®, was created to improve manual ventilation delivery among providers. The device is attached to a bag valve mask (i.e. manual resuscitator) and employs a flow limiting valve mechanism to minimize excessive pressure in the airway system without venting air by capping peak flow rates at 55 L/min. For an average adult with normal lung compliance and resistance, this corresponds to a maximum airway pressure of approximately 20 cmH2O which minimizes air entry into the stomach. In this non-inferiority study, a pre-post study design (single group, within-group comparison) to test the non-inferiority of the Adult Sotair® device compared to mechanical ventilation with respect to airway pressure.
- Conditions
- Airway Management, Respiration, Artificial
- Being tested
- ADULT Sotair Device
- Keywords
- Mechanical Ventilation, General Anesthesia, Bag Mask Ventilation, Adult Sotair Device
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADULT Sotair DeviceDevice
Also called Sotair, SafeBVM
Sotair® device employs a flow limiting and pressure control valve mechanism.
| Study group | Role | What they receive |
|---|---|---|
| Bag mask ventilation with Adult Sotair device | Active comparator | The anesthesia provider will manually bag ventilate with the Adult Sotair® device for 3 minutes. Receives: Device: ADULT Sotair Device |
| Mechanical Ventilation | No intervention | The anesthesia provider will remove the bag valve mask and Adult Sotair® device and connect the patient to the mechanical ventilator. The recording of pressure and flow will last for 3 minutes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak airway pressure
mean peak airway pressure expressed in cm H20
Measured: Recorded for 3 minute duration for each arm of the study
Secondary outcomes (5)
Tidal volume
The amount of air that moves in or out of the lungs with each respiratory cycle. Measured in mL.
Measured: Recorded for 3 minute duration for each arm of the study
Airflow
Represents the volume of air moved per unit of time during inspiration and expiration. Measured s
Measured: Recorded for 3 minute duration for each arm of the study
Oxygen saturation (SpO2)
A present of oxygen-bound hemoglobin in the blood.
Measured: Recorded for 3 minute duration for each arm of the study
Blood pressure
Is the measurement of the pressure or force of blood inside your arteries. Measured as mm Hg.
Measured: Recorded for 3 minute duration for each arm of the study
Heart rate
The number of times your heart beats per minute. Measured as beats per minute.
Measured: Recorded for 3 minute duration for each arm of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start20 Dec 2023
- Primary completion28 May 2025
- Study completion28 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Airway ManagementStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Study Design A non-inferiority trial; a pre-post study design (single group, within-group comparison)
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 334 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Kendall, Rhode Island Hospital
- Investigators
- Mark Kendall, MD, Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06117683
- Sponsor's protocol ID
- 1963885
- Status last verified
- Oct 2026
- First submitted
- 31 Oct 2023
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The IPD that underlie results in a publication will be shared with other researchers.
Publications
Fogarty M, Kuck K, Orr J, Sakata D. A comparison of controlled ventilation with a noninvasive ventilator versus traditional mask ventilation. J Clin Monit Comput. 2020 Aug;34(4):771-777. doi: 10.1007/s10877-019-00365-1. Epub 2019 Jul 23.
PubMed 31338661von Goedecke A, Bowden K, Wenzel V, Keller C, Gabrielli A. Effects of decreasing inspiratory times during simulated bag-valve-mask ventilation. Resuscitation. 2005 Mar;64(3):321-5. doi: 10.1016/j.resuscitation.2004.09.003.
PubMed 15733761Culbreth RE, Gardenhire DS. Manual bag valve mask ventilation performance among respiratory therapists. Heart Lung. 2021 May-Jun;50(3):471-475. doi: 10.1016/j.hrtlng.2020.10.012. Epub 2020 Nov 1.
PubMed 33138977Hutten MC, Goos TG, Ophelders D, Nikiforou M, Kuypers E, Willems M, Niemarkt HJ, Dankelman J, Andriessen P, Mohns T, Reiss IK, Kramer BW. Fully automated predictive intelligent control of oxygenation (PRICO) in resuscitation and ventilation of preterm lambs. Pediatr Res. 2015 Dec;78(6):657-63. doi: 10.1038/pr.2015.158. Epub 2015 Aug 31.
PubMed 26322409
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-inferiority Comparative Trial Between Sotair® Device Attached to Manual Resuscitator Versus Mechanical Ventilation in Patients Undergoing Non-emergent Surgery With General Anesthesia
- ClinicalTrials.gov ID
- NCT06117683
- Acronym / sponsor ID
- 1963885
- Conditions
- Airway Management, Respiration, Artificial
- Keywords
- Mechanical Ventilation, General Anesthesia, Bag Mask Ventilation, Adult Sotair Device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 334 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- 28 May 2025 (actual)
- Study completion
- 28 May 2025 (actual)
- First posted
- 7 Nov 2023 (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.
Effective respiratory ventilation is achieved by moving the right amount of air in and out of the lungs while keeping the pressures at a safe level. A disposable safety device, Adult Sotair®, was created to improve manual ventilation delivery. In this non-inferiority study, we will perform a pre-post study design (single group, within-group comparison) to test the non-inferiority of the Adult Sotair® device compared to mechanical ventilation.
Detailed description
Poor manual ventilation technique is a well-documented problem which occurs irrespective of a provider's qualifications or experience. A disposable safety device, Adult Sotair®, was created to improve manual ventilation delivery among providers. The device is attached to a bag valve mask (i.e. manual resuscitator) and employs a flow limiting valve mechanism to minimize excessive pressure in the airway system without venting air by capping peak flow rates at 55 L/min. For an average adult with normal lung compliance and resistance, this corresponds to a maximum airway pressure of approximately 20 cmH2O which minimizes air entry into the stomach. In this non-inferiority study, a pre-post study design (single group, within-group comparison) to test the non-inferiority of the Adult Sotair® device compared to mechanical ventilation with respect to airway pressure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Study Design A non-inferiority trial; a pre-post study design (single group, within-group comparison)
| Arm | Type | Receives |
|---|---|---|
| Bag mask ventilation with Adult Sotair device | Active comparator | Device: ADULT Sotair DeviceThe anesthesia provider will manually bag ventilate with the Adult Sotair® device for 3 minutes. |
| Mechanical Ventilation | No intervention | –The anesthesia provider will remove the bag valve mask and Adult Sotair® device and connect the patient to the mechanical ventilator. The recording of pressure and flow will last for 3 minutes. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients who are scheduled for non-emergency surgery with general anesthesia at Rhode Island Hospital.
- American Society of Anesthesiologists physical status 1 and 2
Key exclusion criteria (2 listed)
- ASA PS >3 (e.g., respiratory disease)
- Oropharyngeal or facial pathology
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 |
|---|---|---|
| ADULT Sotair DeviceAlso: Sotair, SafeBVMSotair® device employs a flow limiting and pressure control valve mechanism. | Device | Bag mask ventilation with Adult Sotair device |
Primary outcome
Peak airway pressure
Time frame: Recorded for 3 minute duration for each arm of the study
mean peak airway pressure expressed in cm H20
5 secondary outcomes
Tidal volume
Time frame: Recorded for 3 minute duration for each arm of the study
Airflow
Time frame: Recorded for 3 minute duration for each arm of the study
Oxygen saturation (SpO2)
Time frame: Recorded for 3 minute duration for each arm of the study
Blood pressure
Time frame: Recorded for 3 minute duration for each arm of the study
Heart rate
Time frame: Recorded for 3 minute duration for each arm of the study
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 2 Nov 2026.
- Background: PubMed 31338661Fogarty M, Kuck K, Orr J, Sakata D. A comparison of controlled ventilation with a noninvasive ventilator versus traditional mask ventilation. J Clin Monit Comput. 2020 Aug;34(4):771-777. doi: 10.1007/s10877-019-00365-1. Epub 2019 Jul 23.
- Background: PubMed 15733761von Goedecke A, Bowden K, Wenzel V, Keller C, Gabrielli A. Effects of decreasing inspiratory times during simulated bag-valve-mask ventilation. Resuscitation. 2005 Mar;64(3):321-5. doi: 10.1016/j.resuscitation.2004.09.003.
- Background: PubMed 33138977Culbreth RE, Gardenhire DS. Manual bag valve mask ventilation performance among respiratory therapists. Heart Lung. 2021 May-Jun;50(3):471-475. doi: 10.1016/j.hrtlng.2020.10.012. Epub 2020 Nov 1.
- Background: PubMed 26322409Hutten MC, Goos TG, Ophelders D, Nikiforou M, Kuypers E, Willems M, Niemarkt HJ, Dankelman J, Andriessen P, Mohns T, Reiss IK, Kramer BW. Fully automated predictive intelligent control of oxygenation (PRICO) in resuscitation and ventilation of preterm lambs. Pediatr Res. 2015 Dec;78(6):657-63. doi: 10.1038/pr.2015.158. Epub 2015 Aug 31.
- Adult Sotair ProductsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The IPD that underlie results in a publication will be shared with other researchers.
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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.
Mark Kendall, MD principal investigator
Rhode Island Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ADULT Sotair Device in people with Airway Management and Respiration, Artificial, run by Rhode Island Hospital 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 2 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 2 Nov 2026. 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?
Peak airway pressure (time frame: Recorded for 3 minute duration for each arm of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06117683, which also lists 4 linked publications.
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 2 Nov 2026.