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A Randomised Crossover Study to Explore the Physiological Impact of AIR+ Smart Masks on Children

NCT03252574 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2018-08-08

No results posted yet for this study

Summary

The primary objective is to evaluate the physiological impact of AIR+ Smart Masks on end-tidal carbon dioxide (ETCO2) of children aged 7 to 14 years of age. The secondary outcomes include other physiological parameters such as oxygen saturation (SPO2), heart rate (HR) and respiratory rate (RR). In addition, we will assess the general well-being and comfort level of the child when wearing the AIR+Smart Mask with and without micro-ventilator.

Conditions

  • Healthy Subjects

Interventions

OTHER

A

AIR+ Smart Mask Only

OTHER

B

AIR+ Smart Mask with micro-ventilator

Sponsors & Collaborators

  • National University Hospital, Singapore

    collaborator OTHER

  • KK Women's and Children's Hospital

    collaborator OTHER_GOV

  • Innosparks Pte Ltd.

    lead INDUSTRY

Principal Investigators

  • Daniel Goh, A/P · NUH

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
7 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2016-08-31
Completion
2017-12-31

Countries

  • Singapore

Study Locations

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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 NCT03252574 on ClinicalTrials.gov