Neo RQI: The Effect of Neonatal Resuscitation Quality Improvement Cart Booster Training Skills Retention
Primary Purpose
Ventilatory Failure
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Booster Training with the Neonatal Resuscitation Quality Improvement Cart
Sponsored by
About this trial
This is an interventional other trial for Ventilatory Failure
Eligibility Criteria
Inclusion Criteria:
- Any Neonatal Resuscitation Program-card carrying provider at the participating sites (University of Texas Southwestern, Stanford University and St. Louis University).
Exclusion Criteria:
- Novice providers, who have never taken an Neonatal Resuscitation Program course, will be excluded as participant may not be familiar with the equipment to initiate positive pressure ventilation skills without a face-to-face interaction with an instructor
Sites / Locations
- University of Texas, SouthwesternRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Booster Training Group
No Booster Training Group
Arm Description
Participants randomized to intervention will undergo booster training sessions with the RQI cart (including audiovisual feedback) at 3, 6 and 9 months post instructor-led training session. Following each of these booster sessions, the participants will undergo 1 minute assessments, without feedback.
Participants randomized to the control group will undergo 1 minute assessments, without feedback, at 6 and 9 months. Participants will not be able to access the RQI cart outside of their assessment.
Outcomes
Primary Outcome Measures
Mask Leak
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
Secondary Outcome Measures
Tidal volumes
Measured percentage of breaths provided in goal range for tidal volume
Positive Pressure Ventilation composite score
Calculated score, based on peak inspiratory pressure score, positive end expiratory pressure score, rate score, and mask leak score, per provider at each assessment
Peak Inspiratory Pressure score
Measured percentage of breaths provided in goal range for peak inspiratory pressure
Positive End Expiratory Pressure score
Measured percentage of breaths provided in goal range for positive end expiratory pressure
Rate score
Measured percentage of breaths provided in goal range for rate
Full Information
NCT ID
NCT05147922
First Posted
November 23, 2021
Last Updated
March 31, 2023
Sponsor
University of Texas Southwestern Medical Center
Collaborators
American Academy of Pediatrics
1. Study Identification
Unique Protocol Identification Number
NCT05147922
Brief Title
Neo RQI: The Effect of Neonatal Resuscitation Quality Improvement Cart Booster Training Skills Retention
Official Title
Neo RQI: Evaluating the Effect of Neonatal Resuscitation Quality Improvement Cart Booster Training on Provider Positive Pressure Ventilation Skills Retention
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 18, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
American Academy of Pediatrics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
Detailed Description
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
1. PPV skill proficiency during baseline pre-instructor led training assessment: Based on the pre-training skill assessment, each participant will be coded as a Group A [Proficient] or Group B [not proficient]. Participants will be considered proficient if participants are able to achieve low mask leak (< 30%) on >80% of ventilations provided. Only study Principal investigator and research nurse will have access to this data. 2. Profession 3. Experience (number of times positive pressure ventilation performed on a newborn in the last 6 months) 4. Last time NRP course attended and 5. Institution. Based on this information, the randomization website will assign them to the intervention (booster training) or control group (no booster training) with 1:1 allocation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilatory Failure
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Booster Training Group
Arm Type
Experimental
Arm Description
Participants randomized to intervention will undergo booster training sessions with the RQI cart (including audiovisual feedback) at 3, 6 and 9 months post instructor-led training session. Following each of these booster sessions, the participants will undergo 1 minute assessments, without feedback.
Arm Title
No Booster Training Group
Arm Type
No Intervention
Arm Description
Participants randomized to the control group will undergo 1 minute assessments, without feedback, at 6 and 9 months. Participants will not be able to access the RQI cart outside of their assessment.
Intervention Type
Behavioral
Intervention Name(s)
Booster Training with the Neonatal Resuscitation Quality Improvement Cart
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mask Leak
Description
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 months after initial enrollment and instructor-led training session
Secondary Outcome Measure Information:
Title
Tidal volumes
Description
Measured percentage of breaths provided in goal range for tidal volume
Time Frame
6 month and 9 month assessments
Title
Positive Pressure Ventilation composite score
Description
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
Title
Peak Inspiratory Pressure score
Description
Measured percentage of breaths provided in goal range for peak inspiratory pressure
Time Frame
6 month and 9 month assessments
Title
Positive End Expiratory Pressure score
Description
Measured percentage of breaths provided in goal range for positive end expiratory pressure
Time Frame
6 month and 9 month assessments
Title
Rate score
Description
Measured percentage of breaths provided in goal range for rate
Time Frame
6 month and 9 month assessments
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Any Neonatal Resuscitation Program-card carrying provider at the participating sites (University of Texas Southwestern, Stanford University and St. Louis University).
Exclusion Criteria:
Novice providers, who have never taken an Neonatal Resuscitation Program course, will be excluded as participant may not be familiar with the equipment to initiate positive pressure ventilation skills without a face-to-face interaction with an instructor
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Priya Sharma, MD
Phone
9082279194
Email
priya.sharma@utsouthwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Priya Sharma, MD
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas, Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75204-2317
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Priya Sharma, MD
Email
priya.sharma@utsouthwestern.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33084392
Citation
Wyckoff MH, Wyllie J, Aziz K, de Almeida MF, Fabres J, Fawke J, Guinsburg R, Hosono S, Isayama T, Kapadia VS, Kim HS, Liley HG, McKinlay CJD, Mildenhall L, Perlman JM, Rabi Y, Roehr CC, Schmolzer GM, Szyld E, Trevisanuto D, Velaphi S, Weiner GM; Neonatal Life Support Collaborators. Neonatal Life Support: 2020 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations. Circulation. 2020 Oct 20;142(16_suppl_1):S185-S221. doi: 10.1161/CIR.0000000000000895. Epub 2020 Oct 21.
Results Reference
background
PubMed Identifier
21081593
Citation
Schmolzer GM, Dawson JA, Kamlin CO, O'Donnell CP, Morley CJ, Davis PG. Airway obstruction and gas leak during mask ventilation of preterm infants in the delivery room. Arch Dis Child Fetal Neonatal Ed. 2011 Jul;96(4):F254-7. doi: 10.1136/adc.2010.191171. Epub 2010 Nov 16.
Results Reference
background
PubMed Identifier
20547584
Citation
Schmolzer GM, Kamlin OC, O'Donnell CP, Dawson JA, Morley CJ, Davis PG. Assessment of tidal volume and gas leak during mask ventilation of preterm infants in the delivery room. Arch Dis Child Fetal Neonatal Ed. 2010 Nov;95(6):F393-7. doi: 10.1136/adc.2009.174003. Epub 2010 Jun 14.
Results Reference
background
PubMed Identifier
23571117
Citation
Martin P, Theobald P, Kemp A, Maguire S, Maconochie I, Jones M. Real-time feedback can improve infant manikin cardiopulmonary resuscitation by up to 79%--a randomised controlled trial. Resuscitation. 2013 Aug;84(8):1125-30. doi: 10.1016/j.resuscitation.2013.03.029. Epub 2013 Apr 6.
Results Reference
background
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Neo RQI: The Effect of Neonatal Resuscitation Quality Improvement Cart Booster Training Skills Retention
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