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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 19, 2020

Detailed 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.

Interventions

  • Other: Barrier box
    • Placement of barrier box ( a plastic box for shielding)

Arms, Groups and Cohorts

  • Experimental: Barrier box
    • Participants will have a barrier box placed during intubation
  • No Intervention: No Barrier box
    • Participants will have routine intubation with no barrier box

Clinical Trial Outcome Measures

Primary Measures

  • Time to intubate
    • Time Frame: up to 10 minutes
    • Number of seconds to intubate (from loss of twitches confirmed with a peripheral nerve stimulator to confirmation of end tidal carbon dioxide.

Secondary Measures

  • Attempts at intubation
    • Time Frame: up to 10 minutes
    • Number of attempts at intubation
  • Need for bag mask ventilation
    • Time Frame: up to 10 minutes
    • 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.
  • Lowest oxygen saturation during induction and intubation
    • Time Frame: up to 10 minutes
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The Guthrie Clinic
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Praneeth Madabhushi, MD, MHCA, Principal Investigator, The Guthrie Clinic

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