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

NCT05147922 | Completed

• 1 other identifier: STU2021-0282
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

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

Conditions

Ventilatory Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Tidal volumes

  6 month and 9 month assessments

• Positive Pressure Ventilation composite score

  6 month and 9 month assessments

• Peak Inspiratory Pressure score

  6 month and 9 month assessments

• Positive End Expiratory Pressure score

  6 month and 9 month assessments

• Rate score

  6 month and 9 month assessments

Study Arms (2)

Booster Training Group

EXPERIMENTAL

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

No Booster Training Group

NO INTERVENTION

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.

Interventions

Booster Training with the Neonatal Resuscitation Quality Improvement Cart BEHAVIORAL

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.

Booster Training Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Any Neonatal Resuscitation Program-card carrying provider at the participating sites (University of Texas Southwestern, Stanford University and St. Louis University).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• American Academy of Pediatrics: collaborator

Study Sites (1)

University of Texas, Southwestern

Dallas, Texas, 75204-2317, United States

Location

Related Publications (4)

• 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.

  PMID: 33084392 BACKGROUND

• 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.

  PMID: 21081593 BACKGROUND

• 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.

  PMID: 20547584 BACKGROUND

• 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.

  PMID: 23571117 BACKGROUND

MeSH Terms

Conditions

Hypoventilation

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Priya Sharma, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor- Pediatrics

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: December 7, 2021
• Study Start: April 18, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)