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

NCT05349175 | Completed

• 1 other identifier: 2013P002204b
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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 (6)

• Effective bag-mask ventilation

  Duration of effective bag-mask ventilation by clinician during a 2-minute trial. 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 all 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 -- timed from when the mask first touches the face of the manikin until all three icons are green. This is measured by an observer 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).

  2 minutes

• Bag-mask ventilation skills immediately after training

  Clinicians' bag-mask ventilation skills will be assessed immediately after training. Assessment of these skills will be done using current standards, namely the HBB program's 'Bag-mask ventilation skills test' and 'OSCE B.'

  Immediately after training

• Bag-mask ventilation skills 2 months post-training

  Clinicians' bag-mask ventilation skills will be assessed 2 months after training. Assessment of these skills will be done using current standards, namely the HBB program's 'Bag-mask ventilation skills test' and 'OSCE B.'

  2 months after training

• Bag-mask ventilation skills 4 months post-training

  Clinicians' bag-mask ventilation skills will be assessed 4 months after training. Assessment of these skills will be done using current standards, namely the HBB program's 'Bag-mask ventilation skills test' and 'OSCE B.'

  4 months after training

• Bag-mask ventilation skills 6 months post-training

  Clinicians' bag-mask ventilation skills will be assessed 6 months after training. Assessment of these skills will be done using current standards, namely the HBB program's 'Bag-mask ventilation skills test' and 'OSCE B.'

  6 months after training

Secondary Outcomes (3)

• Provider-level perceptions - focus groups

  6 months

• Provider-level perceptions - interviews

  6 months

• Cost analysis

  6 months

Study Arms (3)

Cohort A

EXPERIMENTAL

Receives AIR device feedback beginning immediately after training

Device: Augmented Infant Resuscitator (AIR)

Cohort B

EXPERIMENTAL

Receives AIR device feedback beginning 2 months after training

Device: Augmented Infant Resuscitator (AIR)

Cohort C

EXPERIMENTAL

Receives AIR device feedback beginning 4 months after training

Device: Augmented Infant Resuscitator (AIR)

Interventions

Augmented Infant Resuscitator (AIR) DEVICE

Real-time visual feedback from the AIR device regarding quality of bag-mask ventilation

Cohort A; Cohort B; Cohort C

Eligibility Criteria

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

You may qualify if:

• Skilled birth attendants (SBAs) working clinically at the selected facilities (i.e., in-service providers)
• SBAs who participate in the HBB training offered by our group at the beginning of the study
• SBAs who demonstrate competence, after initial training, in key neonatal resuscitation skills and competencies (i.e., pass the BMV skills check and OSCE B)
• SBAs able to adequately understand the language in which the HBB training is offered (e.g., the investigators anticipate the trainings will be offered in English)
• SBAs over 18 years of age
• SBAs who provide written informed consent for participation in the study

You may not qualify if:

• Students or clinicians still in training (i.e., pre-service providers)
• SBAs and other health workers who do not participate in initial HBB training
• SBAs that are unable to adequately understand the language in which the HBB training is offered
• SBAs under 18 years of age
• SBAs who do not provide written informed consent for participation in the study

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• United States Agency for International Development (USAID): collaborator
• Grand Challenges Canada: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

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 RESULT

• Ali A, Nudel J, Heberle CR, Santorino D, Olson KR, Hur C. Cost effectiveness of a novel device for improving resuscitation of apneic newborns. BMC Pediatr. 2020 Jan 30;20(1):46. doi: 10.1186/s12887-020-1925-5.

  PMID: 32000740 RESULT

MeSH Terms

Conditions

Asphyxia Neonatorum

Condition Hierarchy (Ancestors)

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

Study Officials

• Brett D. Nelson, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 15, 2022
• First Posted: April 27, 2022
• Study Start: February 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)