Clinical trial NCT04411056: A Study Comparing Time to Intubate With and Without a Barrier Box
Official title: Time to Adapt in the Pandemic Era: A Prospective Randomized Study Comparing Time to Intubate With and Without the Barrier Box
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation
Lead sponsor: The Guthrie Clinic
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants assigned to barrier box or no barrier box
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to Intubate
timeFrame: up to 2 minutes during intubation before surgery
Secondary outcomes:
measure: Intubation in First Attempt
timeFrame: up to 2 minutes during intubation before surgery
measure: Need for Bag Mask Ventilation
timeFrame: up to 5 minutes
measure: Participants' Lowest Blood Oxygen Level (Lowest Oxygen Saturation During Induction and Intubation)
timeFrame: up to 5 minutes
measure: Induction Time
timeFrame: up to 5 minutes
Other outcomes:
measure: Airway Assessment by Mallampati Score (Scale of 0 to 4)
timeFrame: Up to 5 minutes
measure: Airway Assessment by Thyromental Distance (TMD)
timeFrame: Up to 5 minutes
measure: Airway Assessment by Inter Incisor Distance
timeFrame: Up to 5 minutes
measure: Neck Range of Motion
timeFrame: Up to 5 minutes
Locations:
city: Sayre
country: United States
facility: Robert Packer Hospital
state: Pennsylvania
Study officials:
affiliation: The Guthrie Clinic
name: Praneeth Madabhushi, MD, MHCA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.