Augmented Infant Resuscitator to Enhance Newborn Ventilation

NCT04820504 | Completed

• 1 other identifier: 2013P002204
• Study Type: interventional
• Target: 270
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Asphyxia Neonatorum; Birth Asphyxia; Perinatal Asphyxia

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Blinded to visual feedback from AIR device

PLACEBO COMPARATOR

Providers did not receive AIR device feedback during newborn mannequin ventilation

Device: AIR device without feedback

Not blinded to visual feedback from AIR device

EXPERIMENTAL

Providers did receive AIR device feedback during newborn mannequin ventilation

Device: Augmented Infant Resuscitator (AIR)

Interventions

Augmented Infant Resuscitator (AIR) DEVICE

Device provides visual feedback related to air leak, obstruction, hyperventilation, hypoventilation, and harsh breaths

Also known as: AIR device with feedback

Not blinded to visual feedback from AIR device

AIR device without feedback DEVICE

Device provides no visual feedback to clinician but records data on ventilation effectiveness

Blinded to visual feedback from AIR device

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Related Publications (2)

• 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.

  PMID: 28863023 BACKGROUND

• Data S, Nelson BD, Cedrone K, Mwebesa W, Engol S, Nsiimenta N, Olson KR. Real-Time Digital Feedback Device and Simulated Newborn Ventilation Quality. Pediatrics. 2023 Nov 1;152(5):e2022060599. doi: 10.1542/peds.2022-060599.

  PMID: 37873596 DERIVED

MeSH Terms

Conditions

Asphyxia Neonatorum

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: March 29, 2021
• Study Start: July 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: March 29, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share