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NCT06261619 · ClinicalTrials.gov registry record · NA
Superiority Trial Between Sotair® Device Attached to Manual Resuscitator Versus Ventilation Alone
A NA study of Respiration, Artificial and Airway Management, sponsored by Rhode Island Hospital.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT06261619: Completed NA study of Respiration, Artificial and Airway Management, sponsored by Rhode Island Hospital.
NCT06261619 is a NA study of Respiration, Artificial and Airway Management that has completed, run by Rhode Island Hospital. The registered enrollment target is 30 participants, below the 2,406-participant average among 6 other Respiration, Artificial trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06261619, a NA study of Respiration, Artificial and Airway Management, has completed, sponsored by Rhode Island Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Mean of the maximum peak airway pressures expressed in cm H2O
Conditions Studied
Interventions
- DEVICE Adult Sotair Device
Study Locations (1)
Rhode Island
- Rhode Island Hospital - Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2024-05-09 |
| Est. Completion | 2025-03-18 |
| Phase | NA |
What the finished NCT06261619 record still lists
NCT06261619 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 2,406-participant average among 6 other Respiration, Artificial trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Respiration, Artificial appearing as the primary indexed condition, and to 1 intervention - of which Adult Sotair Device is the first listed.
NCT06261619 reports a single indexed study location in Rhode Island.
Frequently Asked Questions
What is clinical trial NCT06261619 about?
NCT06261619 is a clinical study titled "Superiority Trial Between Sotair® Device Attached to Manual Resuscitator Versus Ventilation Alone". 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 perfor...
What is the current status of trial NCT06261619?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2024-05-09. Estimated completion is 2025-03-18.
What conditions does trial NCT06261619 study?
This clinical trial studies the following conditions: Respiration, Artificial, Airway Management.
What interventions are being tested in trial NCT06261619?
The interventions under investigation include: Adult Sotair Device (DEVICE).
Who is sponsoring clinical trial NCT06261619?
This trial is sponsored by Rhode Island Hospital, which has 130 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06261619 being conducted?
This trial has 1 study location across Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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