Superiority Trial Between Sotair® Device Attached to Manual Resuscitator Versus Ventilation Alone

NCT06261619 | Completed FDA Device

• 1 other identifier: 2079951
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Effective respiratory ventilation is achieved by moving the right amount of air to 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 superiority study, the investigators will perform two-group cross over randomized design to test the superiority of the Adult Sotair® device compared to manual ventilation alone.

Conditions

Airway Management; Respiration, Artificial

Keywords

Mechanical Ventilation; General Anesthesia; Bag Mask Ventilation; Adult Sotair Device

Outcome Measures

Primary Outcomes (1)

• Peak airway pressure

  Mean of the maximum peak airway pressures expressed in cm H2O

  Recorded every thirty seconds for a total duration of 3 minutes for each arm of the study

Secondary Outcomes (2)

• Tidal volume

  Recorded every thirty seconds for a total duration of 3 minutes for each arm of the study

• Airflow

  Recorded every thirty seconds for a total duration of 3 minutes for each arm of the study

Study Arms (2)

Bag mask ventilation with Adult Sotair device

ACTIVE COMPARATOR

The anesthesia provider will manually bag ventilate with the Adult Sotair® device for 3 minutes with an average respiratory rate of 12 breaths per minute with a deep breath every 30 seconds.

Device: Adult Sotair Device

Bag mask ventilation

NO INTERVENTION

The anesthesia provider will manually bag ventilate for 3 minutes with an average respiratory rate of 12 breaths per minute with a deep breath every 30 seconds.

Interventions

Adult Sotair Device DEVICE

Adult Sotair® device employs a flow limiting valve mechanism.

Also known as: Sotair, SafeBVM

Bag mask ventilation with Adult Sotair device

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients who are scheduled for non-emergency surgery with general anesthesia (w/artificial airway) at Rhode Island Hospital.
• American Society Of Anesthesiologists Physical Status 1 and 2

You may not qualify if:

• American Society of Anesthesiologists Physical Status \>3 (e.g. respiratory disease)
• Oropharyngeal or facial pathology

Sponsors & Collaborators

• Rhode Island Hospital: lead

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Related Publications (3)

• 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.

  PMID: 31338661 BACKGROUND

• 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.

  PMID: 15733761 BACKGROUND

• 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.

  PMID: 33138977 BACKGROUND

Related Links

• Adult Sotair Products

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mark Kendall, MD

  Rhode Island Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The care provider will not know the recorded lung function recordings.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Research

Model Details: Study Design: A superiority trial; a single two-group cross over randomized trial.

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: February 15, 2024
• Study Start: May 9, 2024
• Primary Completion: March 18, 2025
• Study Completion: March 18, 2025
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: The SAP will be available at the end of the trial for three years. The data that supports the findings of the study will be available form the corresponding investigator upon reasonable request.

Locations

US (1)