Clinical trial NCT04366141: COVID-19 (Coronavirus Disease 2019) Intubation Barrier Box
Official title: The Impact of a Barrier Enclosure on Endotracheal Intubation Duration and First Pass Attempt - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Keywords: Personal protective equipment
Barrier box
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2020-04-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This will be a prospective, open-label, randomized controlled trial in which patients will be randomly allocated to two study groups on a 1:1 basis into:

1. COVID-19 barrier box Intervention group: Anesthesiologists will use a COVID barrier box during intubation.
2. Control group: Anesthesiologists will not use a COVID barrier box during intubation. Standard intubation procedures will be followed for intubation.

A block randomization strategy, using a computer-generated sequence of random numbers, will be used. Randomization will occur preoperatively if consented patients meet the eligibility criteria and provide informed consent.
Primary purpose: PREVENTION

Brief summary: The trial will be done to determine the impact of a barrier enclosure, COVID (coronavirus disease -19) barrier box on endotracheal intubation attempts, and duration. This study will be a prospective, open-label, randomized controlled trial. A total of 100 patients scheduled for elective surgery will be randomly assigned in two groups (intervention group and control group). Participating attending anesthesiologists will intubate the intervention group patients with COVID barrier box and the control group patients without the box. The anesthesiologists and the intervention group patients will be surveyed about their perception after the surgery. The result of this study will help in decision making about using COVID barrier box to minimize the viral transmission from patients to healthcare workers during the pandemic.

Detailed description: Purpose:

To assess the time to tracheal intubation (TTI) and first-pass success rate for attending anesthesiologists intubating with COVID-related modifications with or without the use of a COVID barrier box.

Hypothesis:

Using a COVID barrier box for tracheal intubation with COVID-related modifications for attending anesthesiologists would be prolonged compared to not using one.

Justification:

Tracheal intubation is a high-risk time point for attending anesthesiologists to contract COVID. This risk can be minimized by using a proprietary barrier enclosure, COVID barrier box covering a patient's head and neck during intubation. It is crucial to estimate the intubation time and first-pass success rate of using a COVID barrier box for introducing it to intubate critically ill COVID patients. The finding of this study can lead to a ground-breaking measure to minimize viral transmission to healthcare workers during the pandemic.

Objectives:

The primary objective of the study is to determine the TTI as measured by an observer. The secondary objectives are to assess the first-pass success rate, the total time of airway manipulation, as well as anesthesiologists' perception of intubation difficulty, and patients' satisfaction.

Research Design:

This study will be a prospective, open-label, randomized controlled trial. Consented eligible patients will be randomly allocated in a 1:1 ratio to intervention or control groups. A computer-generated sequence of random numbers will be used to randomize patients between groups. Consented eligible attending anesthesiologists will use COVID barrier box for intubating the intervention group but not for the control group. Each anesthesiologist will perform one practice intubation on manikins with the COVID barrier box before initiation of the study. The locally instituted COVID-related modifications will be in place during the practice intubation and intubations during surgery for both groups. A third party observer will monitor intubation time. All attending anesthesiologists and intervention group patients will undertake a post-survey.

Statistical Analysis:

A total of 100 patients with 50 in each group will be included in the study to ensure 99% power to detect a clinically significant TTI difference. Data distribution will be assessed using the Shapiro-Wilk and D'Agostino tests. Time outcomes will be analyzed using t-test or Mann-Whitney test. The first-pass success rate and categorical data about intubation difficulty and patient satisfaction will be analyzed using Fisher's Exact test.

Eligibility criteria: Patient Participant Inclusion Criteria:

1. Healthy American Society of Anesthesiologists (ASA) Classification 1 or 2 adults scheduled for elective surgery requiring orotracheal intubation
2. 18 years of age or older
3. COVID negative (As defined by negative COVID swab plus absence of screening symptoms as defined by: Fever, Cough, Shortness of breath or difficulty breathing, Chills, Repeated shaking with chills, Muscle pain, Headache, Sore throat, New loss of taste or smell)

Anesthesiologist Participant Inclusion Criteria:

1. Attending Anesthesiologist
2. Have performed at least 5 prior intubations using McGrath videolaryngoscopes
3. Have performed at least 5 prior endotracheal intubations with the locally instituted COVID-related modifications
4. Must not have more than one prior experience with using the COVID barrier box on real patients (Prior to the study start; not inclusive of intubations done in the context of this study)
5. Have performed at least one practice intubation on a manikin with the COVID barrier box prior to initiation of study

Patient Participant Exclusion Criteria:

1. Patient refusal, inability to consent or cooperate
2. Claustrophobia
3. Body habitus not allowing physical fit into COVID barrier box
4. History of documented difficult airway
5. Risk factors for difficult airway (Mallampati 3 or 4, thyromental distance less than 6 cm, interincisor distance less than 4 cm, upper lip bite test 2 or 3, body mass index (BMI) 30 or above, macroglossia, airway edema, blood in airway, cervical immobility, or any other concerning features deemed by attending anesthesiologist)
6. Risk factors for gastric aspiration
7. Allergy to rocuronium

Anesthesiologist Participant Exclusion Criteria:

1. Refusal to consent
2. Do not meet any of the inclusion criteria

Primary outcomes:
measure: Time to tracheal intubation (TTI)
timeFrame: This will be measured at the time of intubation for an elective surgical patient. It will take approximately 5 minutes.
Secondary outcomes:
measure: First pass success rate
timeFrame: This will be measured at the time of intubation for an elective surgical patient within 150 seconds of initiating the first attempt to intubate.
measure: Total time of airway manipulation
timeFrame: This will be measured at the time of intubation for an elective surgical patient. It will take approximately 5 minutes.
measure: Number of intubation attempts
timeFrame: This will be filled out as part of a questionnaire after intubation is completed. It will take approximately 10 minutes to complete the full questionnaire..
measure: Number of Operators needed for intubation
timeFrame: This will be filled out as part of a questionnaire after intubation is completed. It will take approximately 10 minutes to complete the full questionnaire..
measure: Number of alternative techniques used for intubation
timeFrame: This will be filled out as part of a questionnaire after intubation is completed. It will take approximately 10 minutes to complete the full questionnaire..
measure: Cormack-Lehane Grade for the first attempt of intubation
timeFrame: This will be filled out as part of a questionnaire after intubation is completed. It will take approximately 10 minutes to complete the full questionnaire..
measure: Lifting force applied on laryngoscope blade
timeFrame: This will be filled out as part of a questionnaire after intubation is completed. It will take approximately 10 minutes to complete the full questionnaire..
measure: Laryngeal pressure application
timeFrame: This will be filled out as part of a questionnaire after intubation is completed. It will take approximately 10 minutes to complete the full questionnaire..
measure: Vocal cord position
timeFrame: This will be filled out as part of a questionnaire after intubation is completed. It will take approximately 10 minutes to complete the full questionnaire..
measure: Anesthesiologist perception of intubation difficulty
timeFrame: This will be filled out as part of a questionnaire after intubation is completed. It will take approximately 10 minutes to complete the full questionnaire..
measure: Anesthesiologist perception of contributors to difficulty in intubation, if any
timeFrame: This will be filled out as part of a questionnaire after intubation is completed. It will take approximately 10 minutes to complete the full questionnaire..
measure: Patient acceptability of the COVID Barrier Box
timeFrame: This question will be asked as part of a short questionnaire administered to patients when they meet the Post Anesthesia Care Unit (PACU) discharge criteria (usually 2 to 5 hours after surgery). It will take about 10 minutes to complete.
measure: Patient comfort with the COVID Barrier Box
timeFrame: This question will be asked as part of a short questionnaire administered to patients when they meet the Post Anesthesia Care Unit (PACU) discharge criteria (usually 2 to 5 hours after surgery). It will take about 10 minutes to complete.
measure: Patient comments on the COVID Barrier Box
timeFrame: This question will be asked as part of a short questionnaire administered to patients when they meet the Post Anesthesia Care Unit (PACU) discharge criteria (usually 2 to 5 hours after surgery). It will take about 10 minutes to complete.
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Providence Health Care
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Anton Chau, MD
role: PRINCIPAL_INVESTIGATOR
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