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

NCT06261619 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-07-03

No results posted yet for this study

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

Interventions

DEVICE

Adult Sotair Device

Adult Sotair® device employs a flow limiting valve mechanism.

Sponsors & Collaborators

  • Rhode Island Hospital

    lead OTHER

Principal Investigators

  • Mark Kendall, MD · Rhode Island Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-09
Primary Completion
2025-03-18
Completion
2025-03-18
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06261619 on ClinicalTrials.gov