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

Part of paid clinical trials in Providence, Rhode Island.

Sponsor
Rhode Island Hospital
Study ID
NCT06117683
Status
Recruiting
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Conditions

  • Airway Management
  • Respiration, Artificial

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • ADULT Sotair Device — DEVICE
    Sotair® device employs a flow limiting and pressure control valve mechanism.

Study Details

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.

Key Dates

Start date
Dec 20, 2023
Status verified
Jul 2025
Primary completion
Jun 30, 2025
Completion
Jul 31, 2025

Study Design

Enrollment
310 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: Bag mask ventilation with Adult Sotair device
    The anesthesia provider will manually bag ventilate with the Adult Sotair® device for 3 minutes.
  • No Intervention: 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.

Primary Outcome Measure

Peak airway pressure [ Time Frame: Recorded for 3 minute duration for each arm of the study ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rhode Island HospitalProvidenceRhode Island02903
Mark Kendall, MD
[email protected]
401-444-5172

Find similar trials in Providence, RI

By research site
Rhode Island Hospital· Providence, RI

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