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NCT03158207 · ClinicalTrials.gov registry record · NA
Safety and Efficacy of a Novel Facemask for Positive Pressure Ventilation
A NA study of Anesthesia Induction Ventilation, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- NA
- Development phase
- 152
- Enrollment target
- 1
- Study location
NCT03158207 is a NA study of Anesthesia Induction Ventilation that has completed, run by Medical University of South Carolina. The registered enrollment target is 152 participants. The trial reports 1 study location across 1 state.
The verdict
NCT03158207, a NA study of Anesthesia Induction Ventilation, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- NA
- Development phase
- 152 participants
- Enrollment target
- 1
- Study location
Study Summary
Positive pressure ventilation can be life saving for patients who are hypoxic, hypercapneic or apneic. Manual ventilation with a facemask is a skill that is routinely required for emergency medical technicians, respiratory therapists, nurses and physicians. Although mask ventilation skills are routinely taught, even the most skilled and experienced anesthesiologists struggle to effectively mask-ventilate. The effective use of a standard mask requires the simultaneous establishment of a seal between the mask and face and the lifting of the jaw. The preferred grip is referred to as the C\&E technique. The C\&E technique requires the index finger and thumb to form a "C" and push down on the mask to establish a seal between the mask and face. The lateral three fingers form the "E" and wrap under the jaw to provide lift. The grip required to establish the seal and jaw lift simultaneously is awkward and difficult to teach. The basic design of the standard facemask has not changed in approximately 100 years. This study will evaluate a new mask design, Warters Mask, is based on a novel design that allows a far more ergonomic grip. The C\&E technique is replaced by a more natural grip. With the Warters Mask, downward pressure with the palm of the hand centered on the mask provides the seal between the face and the mask. The other four fingers align under the jaw to provide lift.
Conditions Studied
Interventions
- DEVICE Waters Mask
- OTHER Standard Mask
Study Locations (1)
South Carolina
- Medical University of South Carolina - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 152 participants |
| Start Date | 2015-09-15 |
| Est. Completion | 2016-12-15 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03158207
The ClinicalTrials.gov registry entry for NCT03158207 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 152 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical University of South Carolina, which has 755 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Anesthesia Induction Ventilation appearing as the primary indexed condition, and to 2 interventions - of which Waters Mask is the first listed.
NCT03158207 reports 1 study location spanning 1 distinct geographic area - top geographies include South Carolina.
Frequently Asked Questions
What is clinical trial NCT03158207 about?
NCT03158207 is a clinical study titled "Safety and Efficacy of a Novel Facemask for Positive Pressure Ventilation". Positive pressure ventilation can be life saving for patients who are hypoxic, hypercapneic or apneic. Manual ventilation with a facemask is a skill that is routinely required for emergency medical technicians, respiratory therapists, nurses and physicians. Although mask ventilation skills are routi...
What is the current status of trial NCT03158207?
This trial is currently completed. It is a NA study. The enrollment target is 152 participants. The study started on 2015-09-15. Estimated completion is 2016-12-15.
What conditions does trial NCT03158207 study?
This clinical trial studies the following conditions: Anesthesia Induction Ventilation.
What interventions are being tested in trial NCT03158207?
The interventions under investigation include: Waters Mask (DEVICE), Standard Mask (OTHER).
Who is sponsoring clinical trial NCT03158207?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03158207 being conducted?
This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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