Neo RQI: The Effect of Neonatal Resuscitation Quality Improvement Cart Booster Training Skills Retention

Neo RQI: Evaluating the Effect of Neonatal Resuscitation Quality Improvement Cart Booster Training on Provider Positive Pressure Ventilation Skills Retention

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

Study Overview

• Status: Completed
• Conditions: Ventilatory Failure
• Intervention / Treatment: Behavioral: Booster Training with the Neonatal Resuscitation Quality Improvement Cart

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.

• Study Type: Interventional
• Enrollment (Actual): 155
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75204-2317
      • University of Texas, Southwestern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Booster Training Group; 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.	Behavioral: Booster Training with the Neonatal Resuscitation Quality Improvement Cart; 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.
No Intervention: No Booster Training Group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months after initial enrollment and instructor-led training session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tidal volumes	Measured percentage of breaths provided in goal range for tidal volume	6 month and 9 month assessments
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	6 month and 9 month assessments
Peak Inspiratory Pressure score	Measured percentage of breaths provided in goal range for peak inspiratory pressure	6 month and 9 month assessments
Positive End Expiratory Pressure score	Measured percentage of breaths provided in goal range for positive end expiratory pressure	6 month and 9 month assessments
Rate score	Measured percentage of breaths provided in goal range for rate	6 month and 9 month assessments

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Collaborators: American Academy of Pediatrics
• Investigators: Principal Investigator: Priya Sharma, MD, University of Texas

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2022
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: November 23, 2021
• First Submitted That Met QC Criteria: November 23, 2021
• First Posted (Actual): December 7, 2021

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Respiratory Insufficiency; Hypoventilation
• Other Study ID Numbers: STU2021-0282

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No