Augmented Infant Resuscitator to Enhance Newborn Ventilation (AIR)

Augmented Infant Resuscitator (AIR): Transitioning a Novel Behavior Change Innovation to Drive Newborn Ventilation Skills Enhancement

Augmented Infant Resuscitator (AIR) is an inexpensive add-on, compatible with nearly every existing bag-valve mask and many types of ventilation equipment. AIR monitors ventilation quality and provides real-time objective feedback and actionable cues to clinicians to both shorten training times and improve resuscitation quality, adoption, retention, and confidence.

Study Overview

• Status: Completed
• Conditions: Perinatal Asphyxia; Asphyxia Neonatorum; Birth Asphyxia
• Intervention / Treatment: Device: AIR device without feedback; Device: Augmented Infant Resuscitator (AIR)

Detailed Description

Longitudinal, randomized control trial that examined the effectiveness of AIR among 270 participants, with 1,080 recorded ventilation scenarios, and across 20 sites in Uganda and the U.S. Birth attendants - including a mix of midwives, nurses, respiratory therapists, pediatricians, and neonatologists - with recent HBB and/or NRP training were recruited to participate in this randomized control trial. Participants ventilated training mannequins for a fixed duration of time. Participants were randomized to receive visual feedback from AIR (intervention) or have the AIR feedback covered (control). They were then requested to administer effective ventilation and verbally assess the mannequin condition. All mannequins appeared to be identical, but each session's mannequin was randomly selected with an upper airway that was normal, partially leaking, or partially obstructed.

• Study Type: Interventional
• Enrollment (Actual): 270
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Midwives, nurses, respiratory therapists, pediatricians, and neonatologists working as birth attendants in select hospitals in Uganda and the U.S. who are either previous trained in Helping Babies Breathe (HBB) and/or have a current Newborn Resuscitation Program (NRP) certification.

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Blinded to visual feedback from AIR device; Providers did not receive AIR device feedback during newborn mannequin ventilation	Device: AIR device without feedback; Device provides no visual feedback to clinician but records data on ventilation effectiveness
Experimental: Not blinded to visual feedback from AIR device; Providers did receive AIR device feedback during newborn mannequin ventilation	Device: Augmented Infant Resuscitator (AIR); Device provides visual feedback related to air leak, obstruction, hyperventilation, hypoventilation, and harsh breaths; Other Names: AIR device with feedback

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effective bag-mask ventilation	Duration of effective bag-mask ventilation by clinician during a 2-minute trial. [This will be a cumulative duration of the two minutes. This is measured internally from the AIR device. "Effective ventilation" is defined as having all three of the following conditions simultaneously: (1) Correct rate (30-60 breaths per minute); (2) Absence of significant leak (compliance >4.0mL/cm H2O); and (3) Absence of a significant airway blockage (defined as compliance <0.10 mL/cm H2O or resistance >90 cmH2O/L/s). These measurements are determined by sensors in the AIR device for both arms of the study. Their accuracy for manikin use was determined to be 100% in the following trial: Bennett el al. Anesth Analgesia. 2018 Mar;126(3):947-955. doi: 10.1213/ANE.0000000000002432.]	2 minutes
Time to effective bag-mask ventilation	How long it takes for clinician to achieve effective ventilation during 2-minute trial. [This is time from when the mask first touches the face of the manikin until all three icons are green. This is measured by a Research Assistant using a stop-watch. Again, "Effective ventilation" is defined as having all three of the following conditions simultaneously and is indicated to the RA by all three icons on the AIR device turning green: (1) Correct rate (30-60 breaths per minute); (2) Absence of significant leak (compliance >4.0mL/cm H2O); and (3) Absence of a significant airway blockage (defined as compliance <0.10 mL/cm H2O or resistance >90 cmH2O/L/s). These measurements are determined by sensors in the AIR device for both arms of the study. Their accuracy for manikin use was determined to be 100% in the following trial: Bennett et al. Anesth Analgesia 2018 Mar;126(3):947-955. doi: 10.1213/ANE.0000000000002432.]	2 minutes
Clinician's correct assessment of mannequin airway issues	Ability of clinician to correctly assess three different manikin airway issues: normal, air leak, or obstruction. [Manikin "conditions" are blinded to the participants and were either normal (as supplied by the manufacturer, had a "leak" insert (introduced compliance >4mL/cm H2O), or had an "obstruction" insert (introduced a reduction in compliance <0.10mL/cm H2O and resistance >90 cm H2O/L/s. As per the parameters in the following paper: Bennett et al. Anesth Analgesia. 2018 Mar;126(3):947-955. doi: 10.1213/ANE.0000000000002432.]	2 minutes

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Publications and helpful links

General Publications

• Bennett DJ, Itagaki T, Chenelle CT, Bittner EA, Kacmarek RM. Evaluation of the Augmented Infant Resuscitator: A Monitoring Device for Neonatal Bag-Valve-Mask Resuscitation. Anesth Analg. 2018 Mar;126(3):947-955. doi: 10.1213/ANE.0000000000002432.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: February 17, 2021
• First Submitted That Met QC Criteria: March 26, 2021
• First Posted (Actual): March 29, 2021

Study Record Updates

• Last Update Posted (Actual): March 29, 2021
• Last Update Submitted That Met QC Criteria: March 26, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Infant, Newborn, Diseases; Death; Asphyxia; Asphyxia Neonatorum
• Other Study ID Numbers: 2013P002204

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