University of Texas, Southwestern
Dallas, Texas, 75204-2317, United States
NCT Number: NCT05147922
This is a prospective multicenter randomized control trial to assess percentage mask leak six months post instructor led positive pressure ventilation skills training in providers who undergo booster training compared to those who do not undergo any booster training
Looking for future studies?
Notify MeAll sexes
Interventional
Not applicable
Dallas, Texas, 75204-2317, United States
Baseline positive pressure ventilation skill assessment of all study participants: Site principal investigators will recruit eligible providers for the trial. Participants will fill out study enrollment sheet which will ask for 1. Demographic information 2. Profession 3. Experience (number of times positive pressure ventilation performed on a newborn in the last 6 months) 4. Last time Neonatal Resuscitation Program course attended and 5. Institution. Participants will perform 1 minute of positive pressure ventilation on the cart. During this baseline assessment, there is no audio-visual feedback or display. The cart will record data on mask leak, pressure used, ventilation rate, head positioning.
Pre-randomization Standardized Instructor Led Skills Training: All study participants will undergo the standard instructor-led positive pressure ventilation skills training. Each site will have a designated study instructor who will remain blinded to the baseline positive pressure ventilation skill assessment data. Study instructors will use a standardized script as a guide for the instructor led positive pressure ventilation skills training. This training will occur with the same manikin and equipment as the one available at the cart. This training will decrease the impact of variability in prior training received by the study participants.
Post- Instructor led positive pressure ventilation skills training Assessment: Immediately after the instructor led training, participants will perform 1-minute positive pressure ventilation on the cart. This will also be a blinded assessment without any display or feedback. Comparison of pre- and post- instructor led training assessments will provide unique data to evaluate if instructor led training changes the positive pressure ventilation skills.
Randomization with minimization procedure: Randomization will be provided by a secure website using the computer-generated randomization and the minimization procedure. The goal of the minimization procedure is to prevent an imbalance of factors that may influence positive pressure ventilation skill retention. Factors that will be taken into account during minimization procedure are
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The cart will give providers audio-visual feedback and walk them through how to perform effective positive pressure ventilation with correct head positioning, appropriate Peak Inspiratory Pressure and Peak End Expiratory Pressure, no mask leak and ventilation rate of 40 per minute. Participants will be able to spend up to 30 minutes with the cart before undergoing their 1 minute assessment, which will be without feedback.
Time frame: 6 months after initial enrollment and instructor-led training session
The primary outcome of the study is the proportion of subjects who provide >80% ventilation with low mask leak (< 30% mask leak) during the one-minute assessment at six months from the instructor led positive pressure ventilation skills training
Time frame: 6 month and 9 month assessments
Measured percentage of breaths provided in goal range for tidal volume
Time frame: 6 month and 9 month assessments
Calculated score, based on peak inspiratory pressure score, positive end expiratory pressure score, rate score, and mask leak score, per provider at each assessment
Time frame: 6 month and 9 month assessments
Measured percentage of breaths provided in goal range for peak inspiratory pressure
Time frame: 6 month and 9 month assessments
Measured percentage of breaths provided in goal range for positive end expiratory pressure
Time frame: 6 month and 9 month assessments
Measured percentage of breaths provided in goal range for rate
University of Texas Southwestern Medical Center
Other
Neo RQI: Evaluating the Effect of Neonatal Resuscitation Quality Improvement Cart Booster Training on Provider Positive Pressure Ventilation Skills Retention
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05813977
Hypoventilation, Pathological Conditions, Signs and Symptoms
Ankara, Turkey (Türkiye)
View Trial DetailsNCT03905382
Hypoventilation, Pathological Conditions, Signs and Symptoms
London, United Kingdom
View Trial DetailsNCT04815304
Acute Respiratory Distress Syndrome, COVID-19
L’Aquila, Italy
View Trial DetailsNCT03971630
Hypoventilation, Pathological Conditions, Signs and Symptoms
Lleida, Spain
View Trial Details