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

Not Applicable

Completed

Conditions: Intubation

Interventions: Other: Barrier box

Registration Number: NCT04411056

Lead Sponsor: The Guthrie Clinic

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 78

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Barrier box	Barrier box	Participants will have a barrier box placed during intubation

Primary Outcome Measures

Name	Time	Method
Time to Intubate	up to 2 minutes during intubation before surgery	Time to intubate refers to the time it takes to insert a tube into a patient's trachea to help them breathe. Intubation is a procedure routinely used before surgery to help keep the airway open. The study will compare the time to intubate in two groups, barrier box and no barrier box. In medical terms, time to intubate is the time from loss of twitches confirmed with a peripheral nerve stimulator to confirmation of end tidal carbon dioxide.

Secondary Outcome Measures

Name	Time	Method
Intubation in First Attempt	up to 2 minutes during intubation before surgery	All participants were intubated successfully on the first attempt.
Need for Bag Mask Ventilation	up to 5 minutes	During induction time, there were no patients who needed bag mask ventilation. Bag mask ventilation is a technique used to provide oxygen and ventilation to patients who are not breathing adequately. Induction is the process of transitioning a patient from consciousness to unconsciousness at the beginning of a general anesthetic. The induction time is defined in medical terms as the time taken from propofol bolus to loss of twitches measured with a peripheral nerve stimulator.
Participants' Lowest Blood Oxygen Level (Lowest Oxygen Saturation During Induction and Intubation)	up to 5 minutes	During process of inserting a tube in a patient's trachea (intubation) before surgery and the process of being given anesthesia (induction), there is a point where a patient's blood oxygen level drops to its lowest point during the process. This is referred to as the lowest oxygen saturation. In medical terms this is the lowest peripheral capillary oxygen saturation during the induction time defined as the time taken from propofol bolus to loss of twitches measured with a peripheral nerve stimulator. The maximum blood oxygen level is 100%. Normal range is 95% - 100%. Low oxygen level (hypoxemia)is below 95%.
Induction Time	up to 5 minutes	Induction is the process of transitioning a patient from consciousness to unconsciousness at the beginning of a general anesthetic. The induction time is defined in medical terms as the time taken from propofol bolus to loss of twitches measured with a peripheral nerve stimulator.