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

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