Augmented Infant Resuscitator to Enhance Newborn Ventilation

Not Applicable

Completed

• Conditions: Perinatal Asphyxia; Asphyxia Neonatorum; Birth Asphyxia
• Interventions: Device: AIR device without feedback; Device: Augmented Infant Resuscitator (AIR)

• Registration Number: NCT04820504
• Lead Sponsor: Massachusetts General Hospital

Brief 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.

Study Timeline

• Study Start: 2016-07-01
• Primary Completion: 2016-11-01
• Study Completion: 2016-11-01
• Study First Submitted: 2021-02-17
• Status Verified: 2021-03
• Study First Submitted QC: 2021-03-26
• Last Update Submitted: 2021-03-26
• Study First Posted: 2021-03-29
• Last Update Posted: 2021-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blinded to visual feedback from AIR device	AIR device without feedback	Providers did not receive AIR device feedback during newborn mannequin ventilation
Not blinded to visual feedback from AIR device	Augmented Infant Resuscitator (AIR)	Providers did receive AIR device feedback during newborn mannequin ventilation

Primary Outcome Measures

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