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

Intubation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04411056
• Other study ID #: 2004-38
• Status: Completed
• Phase: N/A
• Start date: May 7, 2020
• Est. completion date: May 25, 2020

Study information

• Verified date: June 2020
• Source: The Guthrie Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: May 25, 2020
• Est. primary completion date: May 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intubation

Intervention

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

Locations

Country	Name	City	State
United States	Robert Packer Hospital	Sayre	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
The Guthrie Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Attempts at intubation	Number of attempts at intubation	up to 10 minutes
Secondary	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
Secondary	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