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

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

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.

Study Overview

• Status: Completed
• Conditions: Intubation
• Intervention / Treatment: Other: Barrier box

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.

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Sayre, Pennsylvania, United States, 18840
      • Robert Packer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Barrier box; Participants will have a barrier box placed during intubation	Other: Barrier box; Placement of barrier box ( a plastic box for shielding)
NO_INTERVENTION: No Barrier box; Participants will have routine intubation with no barrier box

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Guthrie Clinic
• Investigators: Principal Investigator: Praneeth Madabhushi, MD, MHCA, The Guthrie Clinic

Publications and helpful links

General Publications

• Madabhushi P, Kinthala S, Ankam A, Chopra N, Porter BR. Time to adapt in the pandemic era: a prospective randomized non -inferiority study comparing time to intubate with and without the barrier box. BMC Anesthesiol. 2020 Sep 14;20(1):232. doi: 10.1186/s12871-020-01149-w.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 7, 2020
• Primary Completion (ACTUAL): May 19, 2020
• Study Completion (ACTUAL): May 25, 2020

Study Registration Dates

• First Submitted: May 27, 2020
• First Submitted That Met QC Criteria: May 27, 2020
• First Posted (ACTUAL): June 2, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 4, 2020
• Last Update Submitted That Met QC Criteria: June 1, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2004-38

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No