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Augmented Infant Resuscitator to Enhance Newborn Ventilation

NCT04820504 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2021-03-29

No results posted yet for this study

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

Interventions

DEVICE

Augmented Infant Resuscitator (AIR)

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

DEVICE

AIR device without feedback

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

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-07-01
Primary Completion
2016-11-01
Completion
2016-11-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04820504 on ClinicalTrials.gov