COVID-19 (Coronavirus Disease 2019) Intubation Barrier Box

NCT04366141 | Completed

• 1 other identifier: H20-01270
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

Personal protective equipment; Barrier box

Outcome Measures

Primary Outcomes (1)

• Time to tracheal intubation (TTI)

  TTI is the time from when the laryngoscope blade passes between the patient's lips until the first upstroke of the capnograph trace. TTI will be measured by a third party observer outside of the operating room.

  This will be measured at the time of intubation for an elective surgical patient. It will take approximately 5 minutes.

Secondary Outcomes (14)

• First pass success rate

  This will be measured at the time of intubation for an elective surgical patient within 150 seconds of initiating the first attempt to intubate.

• Total time of airway manipulation

  This will be measured at the time of intubation for an elective surgical patient. It will take approximately 5 minutes.

• Number of intubation attempts

  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..

• Number of Operators needed for intubation

  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..

• Number of alternative techniques used for intubation

  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..

Study Arms (2)

COVID-19 barrier box intervention group

EXPERIMENTAL

Attending anesthesiologists will use a COVID-19 barrier box for intubating the patient participants of this group.

Device: COVID-19 barrier box

Control group

NO INTERVENTION

Attending anesthesiologists will use standard intubation procedures.

Interventions

COVID-19 barrier box DEVICE

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.

COVID-19 barrier box intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy American Society of Anesthesiologists (ASA) Classification 1 or 2 adults scheduled for elective surgery requiring orotracheal intubation
• years of age or older
• 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)
• Attending Anesthesiologist
• Have performed at least 5 prior intubations using McGrath videolaryngoscopes
• Have performed at least 5 prior endotracheal intubations with the locally instituted COVID-related modifications
• 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)
• Have performed at least one practice intubation on a manikin with the COVID barrier box prior to initiation of study

You may not qualify if:

• Patient refusal, inability to consent or cooperate
• Claustrophobia
• Body habitus not allowing physical fit into COVID barrier box
• History of documented difficult airway
• 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)
• Risk factors for gastric aspiration
• Allergy to rocuronium
• Refusal to consent

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Providence Health Care

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Related Publications (15)

• 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.

  PMID: 22563403 BACKGROUND

• 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.

  PMID: 32243118 BACKGROUND

• 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.

  PMID: 25493156 BACKGROUND

• 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.

  PMID: 23736891 BACKGROUND

• 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.

  PMID: 17042849 BACKGROUND

• 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.

  PMID: 27983871 BACKGROUND

• 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.

  PMID: 19522050 BACKGROUND

• 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.

  PMID: 26336853 BACKGROUND

• 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.

  PMID: 19104167 BACKGROUND

• 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.

  PMID: 32221970 BACKGROUND

• 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.

  PMID: 18635480 BACKGROUND

• 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.

  PMID: 25721326 BACKGROUND

• 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

  BACKGROUND

• Chan A. Should we use an "aerosol box" for intubation? :11.

  BACKGROUND

• 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.

  PMID: 33973161 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Anton Chau, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: April 28, 2020
• Study Start: May 1, 2020
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: February 24, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)