Adhesive Tape Placement on Patients' Masks in the Emergency Department Increases Compliance of Proper Face Mask Use

NCT04812184 | Completed Results FDA Device

• 1 other identifier: IUMASKstudy
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

Brief Summary

Methods 123 patients were enrolled in a randomized controlled trial at Eskenazi Hospital from April 2020 until October 2020. We permitted patients to either use their own mask (due to low resources institutionally) or we provided a surgical/cloth mask (early on relied on donated cloth masks for patients). Patients were randomized to a control (no tape over the mask/nose) or to the intervention (placing tape over the bridge of the nose of the face mask). Patients were evaluated at 30- and 60- minute intervals to assess for proper mask usage.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• Proper Face Mask Use up to 60 Minutes

  The primary outcome of this trial is proper mask utilization upon reevaluation up to 60 minutes (with the mask at/under the chin, meanwhile completely covering the mouth and nose). At these time point a trained observer enters the room and observes the patient's face covering and its location on the face (correct, chin exposed, nose exposed, not on at all).

  60 minutes on Day 1

Study Arms (2)

Surgical Tape to bridge of nose

EXPERIMENTAL

placed a piece of tape to the bridge of the nose, adhering a face mask to the patient's face

Device: Tape Face Mask

Standard of care

NO INTERVENTION

Patients given a mask with no intervention to the mask

Interventions

Tape Face Mask DEVICE

Adding tape to face mask

Surgical Tape to bridge of nose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• presenting to the emergency department during the covid-19 pandemic
• older than 18 years of age

You may not qualify if:

• pregnant
• prisoner
• not english speaking
• not intoxicated or decompensated psychiatric illness
• not critically ill
• not allergic to standard tape and/or tegaderm

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Eskenazi Hospital

Indianapolis, Indiana, 46077, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Nicholas Pettit
• Organization: Indiana University School of Medicine

nrpettit@iu.edu

18653688599

Study Officials

• Nicholas Pettit

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 23, 2021
• Study Start: April 1, 2020
• Primary Completion: October 30, 2020
• Study Completion: October 30, 2020
• Last Updated: October 4, 2022
• Results First Posted: October 4, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)