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NCT06117683 · ClinicalTrials.gov registry record · NA
Non-inferiority Trial Between Sotair® Device Attached to Manual Resuscitator Versus Mechanical Ventilation
A NA study of Respiration, Artificial and Airway Management, sponsored by Rhode Island Hospital.
- Recruiting
- Registry status
- NA
- Development phase
- 310
- Enrollment target
- 1
- Study location
NCT06117683: Recruiting NA study of Respiration, Artificial and Airway Management, sponsored by Rhode Island Hospital.
NCT06117683 is a NA study of Respiration, Artificial and Airway Management that is actively recruiting participants, run by Rhode Island Hospital. The registered enrollment target is 310 participants, below the 2,359-participant average among 6 other Respiration, Artificial trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06117683, a NA study of Respiration, Artificial and Airway Management, is actively recruiting participants, sponsored by Rhode Island Hospital.
- RECRUITING
- Registry status
- NA
- Development phase
- 310 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
mean peak airway pressure expressed in cm H20
Conditions Studied
Interventions
- DEVICE ADULT Sotair Device
Study Locations (1)
Rhode Island
- Rhode Island Hospital - Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 310 participants |
| Start Date | 2023-12-20 |
| Est. Completion | 2025-07 |
| Phase | NA |
What NCT06117683 shows while recruiting
NCT06117683 is an interventional study that assigns participants to a tested intervention. The registered 310 participants enrollment target is mid-sized for trials with a published cap, below the 2,359-participant average among 6 other Respiration, Artificial trials with a reported enrollment target (87% 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.
NCT06117683 reports a single indexed study location in Rhode Island.
Frequently Asked Questions
What is clinical trial NCT06117683 about?
NCT06117683 is a clinical study titled "Non-inferiority Trial Between Sotair® Device Attached to Manual Resuscitator Versus Mechanical Ventilation". 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-pos...
What is the current status of trial NCT06117683?
This trial is currently recruiting. It is a NA study. The enrollment target is 310 participants. The study started on 2023-12-20. Estimated completion is 2025-07.
What conditions does trial NCT06117683 study?
This clinical trial studies the following conditions: Respiration, Artificial, Airway Management.
What interventions are being tested in trial NCT06117683?
The interventions under investigation include: ADULT Sotair Device (DEVICE).
Who is sponsoring clinical trial NCT06117683?
This trial is sponsored by Rhode Island Hospital, which has 130 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06117683 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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