NCT04820504

Augmented Infant Resuscitator to Enhance Newborn Ventilation

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 270 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

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.

Conditions

• Asphyxia Neonatorum
• Birth Asphyxia
• Perinatal Asphyxia

Interventions

Type	Name	Description
DEVICE	Augmented Infant Resuscitator (AIR)	Device provides visual feedback related to air leak, obstruction, hyperventilation, hypoventilation, and harsh breaths
DEVICE	AIR device without feedback	Device provides no visual feedback to clinician but records data on ventilation effectiveness

Timeline

• Start date: 2016-07-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2021-03-29
• Last updated: 2021-03-29