COVID-19 (Coronavirus Disease 2019) Intubation Barrier Box
NCT ID: NCT04366141
Last Updated: 2021-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2020-05-01
2021-02-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
PREVENTION
NONE
Study Groups
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COVID-19 barrier box intervention group
Attending anesthesiologists will use a COVID-19 barrier box for intubating the patient participants of this group.
COVID-19 barrier box
Attending anesthesiologists will use a plastic proprietary barrier enclosure for intubating patients in the intervention group to protect spreading aerosolized droplets from patient to health care provider.
Control group
Attending anesthesiologists will use standard intubation procedures.
No interventions assigned to this group
Interventions
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COVID-19 barrier box
Attending anesthesiologists will use a plastic proprietary barrier enclosure for intubating patients in the intervention group to protect spreading aerosolized droplets from patient to health care provider.
Eligibility Criteria
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Inclusion Criteria
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)
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
Exclusion Criteria
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
1. Refusal to consent
18 Years
ALL
Yes
Sponsors
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University of British Columbia
OTHER
Responsible Party
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Anthony Chau
Clinical Assistant Professor
Principal Investigators
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Anton Chau, MD
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia
Locations
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Providence Health Care
Vancouver, British Columbia, Canada
Countries
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References
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Tran K, Cimon K, Severn M, Pessoa-Silva CL, Conly J. Aerosol generating procedures and risk of transmission of acute respiratory infections to healthcare workers: a systematic review. PLoS One. 2012;7(4):e35797. doi: 10.1371/journal.pone.0035797. Epub 2012 Apr 26.
Canelli R, Connor CW, Gonzalez M, Nozari A, Ortega R. Barrier Enclosure during Endotracheal Intubation. N Engl J Med. 2020 May 14;382(20):1957-1958. doi: 10.1056/NEJMc2007589. Epub 2020 Apr 3. No abstract available.
Sakles JC, Mosier J, Patanwala AE, Dicken J. Learning curves for direct laryngoscopy and GlideScope(R) video laryngoscopy in an emergency medicine residency. West J Emerg Med. 2014 Nov;15(7):930-7. doi: 10.5811/westjem.2014.9.23691. Epub 2014 Oct 29.
Mohr S, Weigand MA, Hofer S, Martin E, Gries A, Walther A, Bernhard M. Developing the skill of laryngeal mask insertion: prospective single center study. Anaesthesist. 2013 Jun;62(6):447-52. doi: 10.1007/s00101-013-2185-7. Epub 2013 Jun 6.
Maharaj CH, O'Croinin D, Curley G, Harte BH, Laffey JG. A comparison of tracheal intubation using the Airtraq or the Macintosh laryngoscope in routine airway management: A randomised, controlled clinical trial. Anaesthesia. 2006 Nov;61(11):1093-9. doi: 10.1111/j.1365-2044.2006.04819.x.
Joshi R, Hypes CD, Greenberg J, Snyder L, Malo J, Bloom JW, Chopra H, Sakles JC, Mosier JM. Difficult Airway Characteristics Associated with First-Attempt Failure at Intubation Using Video Laryngoscopy in the Intensive Care Unit. Ann Am Thorac Soc. 2017 Mar;14(3):368-375. doi: 10.1513/AnnalsATS.201606-472OC.
Savoldelli GL, Schiffer E, Abegg C, Baeriswyl V, Clergue F, Waeber JL. Learning curves of the Glidescope, the McGrath and the Airtraq laryngoscopes: a manikin study. Eur J Anaesthesiol. 2009 Jul;26(7):554-8. doi: 10.1097/eja.0b013e3283269ff4.
Wallace CD, Foulds LT, McLeod GA, Younger RA, McGuire BE. A comparison of the ease of tracheal intubation using a McGrath MAC((R)) laryngoscope and a standard Macintosh laryngoscope. Anaesthesia. 2015 Nov;70(11):1281-5. doi: 10.1111/anae.13209. Epub 2015 Sep 4.
Nouruzi-Sedeh P, Schumann M, Groeben H. Laryngoscopy via Macintosh blade versus GlideScope: success rate and time for endotracheal intubation in untrained medical personnel. Anesthesiology. 2009 Jan;110(1):32-7. doi: 10.1097/ALN.0b013e318190b6a7.
Cook TM, El-Boghdadly K, McGuire B, McNarry AF, Patel A, Higgs A. Consensus guidelines for managing the airway in patients with COVID-19: Guidelines from the Difficult Airway Society, the Association of Anaesthetists the Intensive Care Society, the Faculty of Intensive Care Medicine and the Royal College of Anaesthetists. Anaesthesia. 2020 Jun;75(6):785-799. doi: 10.1111/anae.15054. Epub 2020 Apr 1.
Jones PM, Armstrong KP, Armstrong PM, Cherry RA, Harle CC, Hoogstra J, Turkstra TP. A comparison of glidescope videolaryngoscopy to direct laryngoscopy for nasotracheal intubation. Anesth Analg. 2008 Jul;107(1):144-8. doi: 10.1213/ane.0b013e31816d15c9.
Yao WL, Wan L, Xu H, Qian W, Wang XR, Tian YK, Zhang CH. A comparison of the McGrath(R) Series 5 videolaryngoscope and Macintosh laryngoscope for double-lumen tracheal tube placement in patients with a good glottic view at direct laryngoscopy. Anaesthesia. 2015 Jul;70(7):810-7. doi: 10.1111/anae.13040. Epub 2015 Feb 27.
CDC. Coronavirus Disease 2019 (COVID-19) - Symptoms [Internet]. Centers for Disease Control and Prevention. 2020 [cited 2020 Apr 20]. Available from: https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html
Chan A. Should we use an "aerosol box" for intubation? :11.
Jen TTH, Gusti V, Badh C, Mehta S, Denomme J, Lockhart S, Shams B, Klaibert B, Chau A. The impact of a barrier enclosure on time to tracheal intubation: a randomized controlled trial. Can J Anaesth. 2021 Sep;68(9):1358-1367. doi: 10.1007/s12630-021-02024-z. Epub 2021 May 10.
Other Identifiers
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H20-01270
Identifier Type: -
Identifier Source: org_study_id
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