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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Time to Adapt in the Pandemic Era: A Prospective Randomized Study Comparing Time to Intubate With and Without the Barrier Box

Conditions
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Intubation

Intervention / Treatment
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* Other: Barrier box


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants assigned to barrier box or no barrier box
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Barrier box<br>Participants will have a barrier box placed during intubation | Other: Barrier box<br>* Placement of barrier box ( a plastic box for shielding)<br>|
| No Intervention: No Barrier box<br>Participants will have routine intubation with no barrier box | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to intubate | Number of seconds to intubate (from loss of twitches confirmed with a peripheral nerve stimulator to confirmation of end tidal carbon dioxide. | up to 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attempts at intubation | Number of attempts at intubation | up to 10 minutes | 
| Need for bag mask ventilation | Need for bag mask ventilation (yes or no) during induction, defined as the time taken from propofol bolus to loss of twitches measured with a peripheral nerve stimulator. | up to 10 minutes | 
| Lowest oxygen saturation during induction and intubation | Lowest peripheral capillary oxygen saturation during induction, defined as the time taken from propofol bolus to loss of twitches measured with a peripheral nerve stimulator. | up to 10 minutes |