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Completed

NCT Number: NCT04362163

Study for Testing and Reviewing Improvised PPE Effectiveness 3 (STRIPE-3)

Personal protective equipment (PPE) is vital to ensuring staff safety during the COVID-19 pandemic. Properly designed, formal PPE (fPPE) is in increasingly short supply, and a series of improvised PPE (iPPE) designs have been widely circulated on the internet, particularly on social media. Groups have started to publicise these devices through websites and the lay press. Some are even using crowd-funding to finance the purchase of these systems with the intention of supplying NHS workers in place of approved systems.

It is not clear what degree of testing these systems have undergone. The investigators are already planning trials formally investigating the quality of seal offered by these improvised systems. Currently the team are investigating a designed based on a modified snorkel mask (STRIPE-1). In the current study the investigators wish to extend this investigation to consider the atmosphere within the mask.

This is an important question, as modifications to the snorkel design have changed the way gases mix within the system. This might increase the risk that the user will rebreathe expired gases, which will dilute the amount of oxygen available to them, and increase the carbon dioxide levels to which they are exposed. At extreme deviations, these might pose a potential health hazard over and above the risks posed by COVID-19 exposure via a poor mask seal.

This study will therefore recruit a convenience sample of 10, and request they wear two masks sequentially. These masks will comprise: a formally designed and tested commercial FFP3 mask, and one design of improvised PPE, based on the snorkel design available on the internet.

Each mask will be worn for a total of 40 minutes. In the first 20 minutes measurements will be taken with the user at rest. In the second 20 minutes measurements will be taken while the user undertakes light exercise.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St Thomas' Hospital

London, SE1 7EH, United Kingdom

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Willing and able to give informed consent for participation in the study
  • Healthy adults, male or female, aged 18 or more
  • Clean-shaven at the point of testing
  • Willing and able to undertake 20 minutes of light exercise e.g. stepping

Exclusion criteria

  • They have facial hair that would disrupt the seals of the mask
  • They have significant facial injuries or malformations that preclude a good mask seal

Treatment and study plan

Snorkel-based improvised personal protective equipment

Device

An improvised PPE design based on a full face snorkel mask mated to a heat-and-moisture exchange filter via a 3D printed adaptor.

Primary outcomes

  1. Oxygen concentration while wearing purpose-designed mask

    Time frame: 40 minutes starting from intervention (donning of mask)

    5-minute measurement of oxygen concentration in inspired and expired gases

  2. Oxygen concentration while wearing improvised snorkel-based mask

    Time frame: 40 minutes starting from intervention (donning of mask)

    5-minute measurement of oxygen concentration in inspired and expired gases

Secondary outcomes

  1. Carbon dioxide concentration while wearing purpose-designed mask

    Time frame: 40 minutes starting from intervention (donning of mask)

    5 minute measurement of carbon dioxide concentration in inspired and expired gases

  2. Carbon dioxide concentration while wearing improvised snorkel-based mask

    Time frame: 40 minutes starting from intervention (donning of mask)

    5 minute measurement of carbon dioxide concentration in inspired and expired gases

  3. Heart rate while wearing purpose-designed mask

    Time frame: 40 minutes starting from intervention (donning of mask)

    5 minute measurement of heart rate

  4. Heart rate while wearing improvised snorkel-based mask

    Time frame: 40 minutes starting from intervention (donning of mask)

    5 minute measurement of heart rate

  5. Respiratory rate while wearing purpose-designed mask

    Time frame: 40 minutes starting from intervention (donning of mask)

    5 minute measurement of respiratory rate

  6. Respiratory rate while wearing improvised snorkel-based mask

    Time frame: 40 minutes starting from intervention (donning of mask)

    5 minute measurement of respiratory rate

  7. Oxygen saturation while wearing purpose-designed mask

    Time frame: 40 minutes starting from intervention (donning of mask)

    5 minute measurement of oxygen saturation

  8. Oxygen saturation while wearing improvised snorkel-based mask

    Time frame: 40 minutes starting from intervention (donning of mask)

    5 minute measurement of oxygen saturation

Sponsors and collaborators

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust

Other

Registry information

Official study title

Study for Testing and Reviewing Improvised PPE Effectiveness 3 (STRIPE-3) - a Third Comparative Trial Assessing the Safety of Improvised PPE

Acronym: STRIPE-3

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 24, 2020
Registry last updated
Jun 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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