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

Primary Purpose

Covid19

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tape Face Mask
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Eskenazi Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Surgical Tape to bridge of nose

Standard of care

Arm Description

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

Patients given a mask with no intervention to the mask

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
March 17, 2021
Last Updated
September 12, 2022
Sponsor
Indiana University
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1. Study Identification

Unique Protocol Identification Number
NCT04812184
Brief Title
Adhesive Tape Placement on Patients' Masks in the Emergency Department Increases Compliance of Proper Face Mask Use
Official Title
Adhesive Tape Placement on Patients' Masks in the Emergency Department Increases Compliance of Proper Face Mask Use
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
October 30, 2020 (Actual)
Study Completion Date
October 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Study Design and Setting: This study is a randomized control trial at Eskenazi Hospital ED from April 2020 until October 2020. Eskenazi Hospital is a busy, urban, academic hospital, level 1 trauma center, in downtown Indianapolis. Here we serve a racially diverse, underserved population, with over 100,000 annual ED visits. This work was approved by the Indiana University Institutional Review Board (protocol #2004425945). Selection of Participants: All patients presenting to the ED were screened for enrollment in this study by trained research personnel. All patients are required to wear facial coverings while in the ED, and after screening patients based on the exclusion criteria provided below, patients were offered enrollment in the study. Patients were randomly identified by their bed location in the ED via a random number generator. Patients were excluded from the study for: (1) pregnant; (2) prisoner; (3) not English or Spanish speaking (currently a large cohort of ethnic Latino/Latina/Hispanic are utilizing the ED and we can use interpreters to interpret for enrollment); (4) intoxicated or decompensated psychiatric illness; (5) presenting to the ED with a life-threatening condition; (6) allergic to standard tape and/or tegaderm. Patient consent was obtained if an individual agreed to participate in the study. Interventions: All patients included in this study were approached and offered enrollment in a study for addressing PPE. The control arm consisted of no active intervention, with the treatment arm placing standard surgical tape over the bridge of the nose to adhere the top of the mask to the bridge of the nose, thereby creating a physical barrier from removing the mask from the face. Patients were reevaluated at 30 minutes and 60 minutes after enrollment to assess for proper mask compliance. Measurements: Assuming 50% current compliance, 58 patients per arm were needed to have an 80% power to detect a 25% difference assuming a two-sided chi-square test and alpha = 0.05. Outcomes: The primary outcome of this trial is proper mask utilization upon reevaluation at 30 and 60 minutes, with the mask at/under the chin, meanwhile completely covering the mouth and nose). Secondary outcomes of this trial were comparing the primary demographic and visit related covariates on initial screening, including age, sex, race/ethnicity, past medical history, social history, chief complaint, and disposition (admission vs. discharge). Analysis: Patient demographics and characteristics were compared between the control and treatment groups. To test for differences between groups, Microsoft excel statistical package was utilized, and the Chi-square test was used for categorical variables and the Wilcoxon test for continuous variables.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Surgical Tape to bridge of nose
Arm Type
Experimental
Arm Description
placed a piece of tape to the bridge of the nose, adhering a face mask to the patient's face
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
Patients given a mask with no intervention to the mask
Intervention Type
Device
Intervention Name(s)
Tape Face Mask
Intervention Description
Adding tape to face mask
Primary Outcome Measure Information:
Title
Proper Face Mask Use up to 60 Minutes
Description
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).
Time Frame
60 minutes on Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: presenting to the emergency department during the covid-19 pandemic older than 18 years of age Exclusion Criteria: pregnant prisoner not english speaking not intoxicated or decompensated psychiatric illness not critically ill not allergic to standard tape and/or tegaderm
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas Pettit
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eskenazi Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46077
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
data available upon request

Learn more about this trial

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

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