Augmented Infant Resuscitator to Enhance Newborn Ventilation (AIR)
Primary Purpose
Asphyxia Neonatorum, Birth Asphyxia, Perinatal Asphyxia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Augmented Infant Resuscitator (AIR)
AIR device without feedback
Sponsored by
About this trial
This is an interventional health services research trial for Asphyxia Neonatorum
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Blinded to visual feedback from AIR device
Not blinded to visual feedback from AIR device
Arm Description
Providers did not receive AIR device feedback during newborn mannequin ventilation
Providers did receive AIR device feedback during newborn mannequin ventilation
Outcomes
Primary Outcome Measures
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.]
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.]
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.]
Secondary Outcome Measures
Full Information
NCT ID
NCT04820504
First Posted
February 17, 2021
Last Updated
March 26, 2021
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04820504
Brief Title
Augmented Infant Resuscitator to Enhance Newborn Ventilation
Acronym
AIR
Official Title
Augmented Infant Resuscitator (AIR): Transitioning a Novel Behavior Change Innovation to Drive Newborn Ventilation Skills Enhancement
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2016 (Actual)
Primary Completion Date
November 1, 2016 (Actual)
Study Completion Date
November 1, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asphyxia Neonatorum, Birth Asphyxia, Perinatal Asphyxia
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
270 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Blinded to visual feedback from AIR device
Arm Type
Placebo Comparator
Arm Description
Providers did not receive AIR device feedback during newborn mannequin ventilation
Arm Title
Not blinded to visual feedback from AIR device
Arm Type
Experimental
Arm Description
Providers did receive AIR device feedback during newborn mannequin ventilation
Intervention Type
Device
Intervention Name(s)
Augmented Infant Resuscitator (AIR)
Other Intervention Name(s)
AIR device with feedback
Intervention Description
Device provides visual feedback related to air leak, obstruction, hyperventilation, hypoventilation, and harsh breaths
Intervention Type
Device
Intervention Name(s)
AIR device without feedback
Intervention Description
Device provides no visual feedback to clinician but records data on ventilation effectiveness
Primary Outcome Measure Information:
Title
Effective bag-mask ventilation
Description
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 Frame
2 minutes
Title
Time to effective bag-mask ventilation
Description
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.]
Time Frame
2 minutes
Title
Clinician's correct assessment of mannequin airway issues
Description
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.]
Time Frame
2 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28863023
Citation
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.
Results Reference
background
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Augmented Infant Resuscitator to Enhance Newborn Ventilation
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