COVID-19 (Coronavirus Disease 2019) Intubation Barrier Box

COVID-19 Clinical Trial

Official title:

The Impact of a Barrier Enclosure on Endotracheal Intubation Duration and First Pass Attempt - A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04366141
• Other study ID #: H20-01270
• Status: Completed
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: February 1, 2021

Study information

• Verified date: February 2021
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 1, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Canada	Providence Health Care	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

References & Publications (14)

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. — View Citation

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.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Sakles JC, Mosier J, Patanwala AE, Dicken J. Learning curves for direct laryngoscopy and GlideScope® 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. — View Citation

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. — View Citation

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. Review. — View Citation

Wallace CD, Foulds LT, McLeod GA, Younger RA, McGuire BE. A comparison of the ease of tracheal intubation using a McGrath MAC(®) laryngoscope and a standard Macintosh laryngoscope. Anaesthesia. 2015 Nov;70(11):1281-5. doi: 10.1111/anae.13209. Epub 2015 Sep 4. — View Citation

Yao WL, Wan L, Xu H, Qian W, Wang XR, Tian YK, Zhang CH. A comparison of the McGrath® 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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	First pass success rate	A first pass success refers to successful insertion of the McGRATH™ videolaryngoscope or endotracheal tube by an anesthesiologist on the first-attempt without withdrawing from the mouth in no longer than 150 seconds.	This will be measured at the time of intubation for an elective surgical patient within 150 seconds of initiating the first attempt to intubate.
Secondary	Total time of airway manipulation	This refers to the time from the face mask seal being lifted to the first upstroke of the capnograph trace.	This will be measured at the time of intubation for an elective surgical patient. It will take approximately 5 minutes.
Secondary	Number of intubation attempts	Participant anesthesiologists will report the number of intubation attempts that were needed to achieve successful 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..
Secondary	Number of Operators needed for intubation	Participant anesthesiologists will report the number of operators needed to assist in successfully intubating the participant.	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..
Secondary	Number of alternative techniques used for intubation	Participant anesthesiologists will report the number of alternative techniques used for intubation (if any) i.e. repositioning of patient, change of materials (blade, endotracheal (ET) tube, addition of stylette), change in approach (nasotracheal vs orotracheal), use of another technique (Fibreoptic bronchoscopy, intubating laryngeal mask airway (LMA)	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..
Secondary	Cormack-Lehane Grade for the first attempt of intubation	Participant anesthesiologists will report the Cormack-Lehane Grade for the first attempt of 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..
Secondary	Lifting force applied on laryngoscope blade	Participant anesthesiologists will report if the lifting force applied on laryngoscope blade was normal or increased.	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..
Secondary	Laryngeal pressure application	Participant anesthesiologists will report if laryngeal pressure, such as Backward Upward Rightward Pressure (BURP) not inclusive of cricoid pressure was applied or not.	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..
Secondary	Vocal cord position	Participant anesthesiologists will report the vocal cord position (either abduction or adduction).	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..
Secondary	Anesthesiologist perception of intubation difficulty	Participant anesthesiologists will report the difficulty experienced during the intubation from a scale of 0 to 10 with 0 being without difficulty and 10 being maximum difficulty.	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..
Secondary	Anesthesiologist perception of contributors to difficulty in intubation, if any	Participant anesthesiologists will report any contributors to difficulties in intubation, or state "none", if no difficulties were experienced.	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..
Secondary	Patient acceptability of the COVID Barrier Box	Patients from the intervention group will report the acceptability of COVID barrier box. They will be asked "How acceptable did you find the use of the COVID barrier box?" and respond on a five-point scale (acceptable, slightly acceptable, neutral, slightly unacceptable, unacceptable).	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.
Secondary	Patient comfort with the COVID Barrier Box	Patients from the intervention group will report their level of comfort experienced with the use of the COVID barrier box. They will be asked "How comfortable did you find the use of the COVID barrier box?" and will respond on a five-point scale (comfortable, slightly comfortable, neither, slightly uncomfortable, uncomfortable).	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.
Secondary	Patient comments on the COVID Barrier Box	Patients from the intervention group will report any comments that they have on the COVID barrier box.	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.