Augmented Infant Resuscitator to Enhance Newborn Ventilation (AIR)

Mass General Brigham

Status: Completed

Conditions: Perinatal Asphyxia; Asphyxia Neonatorum; Birth Asphyxia

Treatments: Device: AIR device without feedback; Device: Augmented Infant Resuscitator (AIR)

Study type: Interventional

Funder types: Other

Identifiers

NCT04820504

2013P002204

Details and patient eligibility

About

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.

Full 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.

Enrollment: 270 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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270 participants in 2 patient groups, including a placebo group

Blinded to visual feedback from AIR device

Placebo Comparator group

Description:

Providers did not receive AIR device feedback during newborn mannequin ventilation

Treatment:

Device: AIR device without feedback

Not blinded to visual feedback from AIR device

Experimental group

Description:

Providers did receive AIR device feedback during newborn mannequin ventilation

Treatment:

Device: Augmented Infant Resuscitator (AIR)