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A Study Comparing Time to Intubate With and Without a Barrier Box

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The Guthrie Clinic

Status

Completed

Conditions

Intubation

Treatments

Other: Barrier box

Study type

Interventional

Funder types

Other

Identifiers

NCT04411056
2004-38

Details and patient eligibility

About

This study is for patients who will be having surgery and will have a breathing tube placed during intubation. The purpose of the research is to study the time it takes to use a barrier box for placement of a breathing tube. A barrier box is a clear box that sits over the head and shoulders of a patient as a breathing tube is placed. The box is used to protect the healthcare provider's exposure to coronavirus in patients who have COVID-19. The study will not include patients who test positive for COVID-19 or who are sick with COVID-19 symptoms. The researchers want to learn how long it takes to use the barrier box before it is used routinely in COVID-19 patients.

Full description

The study will have two groups of 39 patients in each group. Some patients will have a barrier box and some patients will not have a barrier box. Patients will be randomly assigned to the barrier box or no barrier box group. The study will measure the time it takes to place the breathing tube.

Enrollment

78 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • patients presenting for surgery needing general anesthesia with endotracheal intubation
  • pre-operatively tested negative for SARS- CoV-2 virus

Exclusion criteria

  • inability to consent or cooperate,
  • children
  • pregnant women
  • patients with severe cardiopulmonary compromise
  • American Society Anesthesiologists' (ASA) physical status 4 and 5
  • Body Mass Index (BMI) >35
  • known or anticipated difficult airway
  • patients with positive COVID status or unknown COVID status
  • patients who reported claustrophobia in the pre-operative area

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

78 participants in 2 patient groups

Barrier box
Experimental group
Description:
Participants will have a barrier box placed during intubation for a medical procedure. A barrier box is a medical device which was in use from May 1, 2020 to August 20, 2020 during the COVID-19 pandemic. The device is a barrier enclosure to protect healthcare providers caring for or performing medical procedures (such as intubation) on patients who are known or suspected to have COVID-19.
Treatment:
Other: Barrier box
No Barrier box
No Intervention group
Description:
Participants will have routine intubation with no barrier box

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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