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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-07

Study Completion Date

2020-05-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

COVID-19 (Coronavirus Disease 2019) Intubation Barrier Box

NCT04366141

COVID-19

COMPLETED NA

Comparison of Two Different Types of "Spray as You go" Technique for Awake Fiberoptic Intubation

NCT01995292

Awake Fiberoptic Intubation

COMPLETED NA

Biocontainment Device for Aerosol Generating Procedures

NCT04532112

Protective Device (Physical Object) Aerosol Disease Droplet Spread

COMPLETED NA

A Clinical Comparison of Two Marketed Skin Barriers on Healthy Volunteers

NCT01534039

Peristomal Skin Complication

COMPLETED PHASE4

Assessment of an Endotracheal Tube Securement Device

NCT01651260

Respiratory Insufficiency

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intubation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants assigned to barrier box or no barrier box

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Barrier box

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.

Group Type EXPERIMENTAL

Barrier box

Intervention Type OTHER

Placement of barrier box ( a plastic box for shielding)

No Barrier box

Participants will have routine intubation with no barrier box

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Barrier box

Placement of barrier box ( a plastic box for shielding)

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No