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Non-inferiority Trial Between Sotair® Device Attached to Manual Resuscitator Versus Mechanical Ventilation

NCT ID: NCT06117683

Last Updated: 2025-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

310 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-20

Study Completion Date

2025-07-31

Brief Summary

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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.

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Detailed Description

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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

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Airway Management Respiration, Artificial

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Study Design A non-inferiority trial; a pre-post study design (single group, within-group comparison)
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Caregivers
The care provider will not know the recorded lung function recordings.

Study Groups

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Bag mask ventilation with Adult Sotair device

The anesthesia provider will manually bag ventilate with the Adult Sotair® device for 3 minutes.

Group Type ACTIVE_COMPARATOR

ADULT Sotair Device

Intervention Type DEVICE

Sotair® device employs a flow limiting and pressure control valve mechanism.

Mechanical Ventilation

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ADULT Sotair Device

Sotair® device employs a flow limiting and pressure control valve mechanism.

Intervention Type DEVICE

Other Intervention Names

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Sotair SafeBVM

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* ASA PS \>3 (e.g., respiratory disease)
* Oropharyngeal or facial pathology
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rhode Island Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mark Kendall

Director of Clinical Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mark Kendall, MD

Role: PRINCIPAL_INVESTIGATOR

Rhode Island Hospital

Locations

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Rhode Island Hospital

Providence, Rhode Island, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Stephanie Farias

Role: CONTACT

[email protected]
401-444-5172

Mark Brady, MD

Role: CONTACT

[email protected]

Facility Contacts

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Mark Kendall, MD

Role: primary

[email protected]
401-444-5172

References

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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.

Reference Type BACKGROUND
PMID: 31338661 (View on PubMed)

von 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.

Reference Type BACKGROUND
PMID: 15733761 (View on PubMed)

Culbreth 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.

Reference Type BACKGROUND
PMID: 33138977 (View on PubMed)

Hutten 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.

Reference Type BACKGROUND
PMID: 26322409 (View on PubMed)

Related Links

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https://safebvm.com

Adult Sotair Products

Other Identifiers

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1963885

Identifier Type: -

Identifier Source: org_study_id

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