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

NCT03252574 | Completed DMC

• 1 other identifier: ISPL-2015/01059
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• End Tidal Carbon Dioxide

  75 minutes

Secondary Outcomes (3)

• Percent Oxygen Saturation

  75 minutes

• Heart Rate

  75 minutes

• Respiratory Rate

  75 minutes

Study Arms (2)

Sequence AB

OTHER

No mask, followed by AIR+ Smart Mask only (A), then AIR+ Smart Mask with micro-ventilator (B)

Other: A; Other: B

Sequence BA

OTHER

No mask, followed by AIR+ Smart Mask with micro-ventilator (B), then AIR+ Smart Mask only (A).

Other: A; Other: B

Interventions

A OTHER

AIR+ Smart Mask Only

Sequence AB; Sequence BA

B OTHER

AIR+ Smart Mask with micro-ventilator

Sequence AB; Sequence BA

Eligibility Criteria

• Age: 7 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Aged between 7 and 14 years of age (inclusive)
• Subjects and their parent/legal guardian must provide the consent and assent as appropriate to take part in this study.

You may not qualify if:

• Subjects with any known cardiorespiratory conditions (including but not limited to the following: asthma, bronchitis, cystic fibrosis, congenital heart disease, emphysema)
• Subjects with any known medical conditions that may be exacerbated by strenuous activity, including but not limited to the following: exercise-induced asthma, lower respiratory infection (including pneumonia, bronchitis) in the past 2 weeks, anxiety disorders, diabetes, hypertension, or epilepsy/ seizure disorder
• Subjects with any physical disability from medical, orthopaedic or neuromuscular disorders
• Subjects who have an acute upper respiratory tract infection/ moderately severe rhinitis (i.e. blocked nasal passages) on the day of the study
• Subjects who may compromise the integrity of the mask fit (e.g. those with excessive facial hair).

Sponsors & Collaborators

• Innosparks Pte Ltd.: lead
• National University Hospital, Singapore: collaborator
• KK Women's and Children's Hospital: collaborator

Study Sites (1)

Innosparks Pte Ltd, 75 Ayer Rajah Crescent, #02-13

Singapore, 139953, Singapore

Location

Related Publications (3)

• Roberge RJ, Coca A, Williams WJ, Powell JB, Palmiero AJ. Physiological impact of the N95 filtering facepiece respirator on healthcare workers. Respir Care. 2010 May;55(5):569-77.

  PMID: 20420727 BACKGROUND

• Sinkule EJ, Powell JB, Goss FL. Evaluation of N95 respirator use with a surgical mask cover: effects on breathing resistance and inhaled carbon dioxide. Ann Occup Hyg. 2013 Apr;57(3):384-98. doi: 10.1093/annhyg/mes068. Epub 2012 Oct 29.

  PMID: 23108786 BACKGROUND

• Ickx B, Dolomie J-0, Benalouch M et al. Arterial to End-tidal carbon dioxide tension differences in infants and children, JACR, 2155-6148 6: 511. doi:10.4172/2155-6148.1000511

  BACKGROUND

Study Officials

• Daniel Goh, A/P

  NUH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2017
• First Posted: August 17, 2017
• Study Start: July 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: December 1, 2017
• Last Updated: August 8, 2018

Record last verified: 2018-08

Locations

SG (1)