To Compare Videolaryngoscope Against Direct Laryngoscope for Intubation When Powered Air Purifying Respirator is Worn

NCT04424953 | Completed DMC FDA Device

• 1 other identifier: 2020/2329
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Various guidelines for endotracheal intubation (insertion of breathing tube for mechanical ventilation) of Coronavirus Disease 2019 (COVID-19) patients recommend the use of videolaryngoscope (medical device used for intubation that has a camera to visualize the vocal cords between which the breathing tube will pass) over direct laryngoscope (conventionally-used medical device for intubation that depends on anesthetist's direct visualization of vocal cords). The reasons for this recommendation are to maximize the distance between the medical personnel and the patient's face during intubation to decrease the risk of viral particles transmission and to improve intubation success. For patients infected with COVID-19, Powered Air Purifying Respirator (PAPR) is recommended as an alternative to N95 masks during aerosol-generating procedures such as intubation because N95 masks may not fully protect medical personnel from viral transmission during intubation. There is no evidence to suggest that videolaryngoscope (VL) is superior to direct laryngoscope (DL) for intubation when PAPR is donned. The purpose of this study is to determine if McGrath VL is superior to DL for intubation when the anesthetist is wearing a PAPR. The investigators' hypothesis is that McGrath VL will decrease the time to intubation by 20 seconds and more compared to DL when PAPR is donned. The investigators also hope to learn if there is any difference in the difficulties encountered between the use of VL and DL.

Conditions

Coronavirus Infection; Ventilatory Failure; Anesthesia Intubation Complication

Keywords

Intubation; Direct laryngoscope; Video laryngoscope; Personal protective equipment; Powered Air Purifying Respirator; Coronavirus Disease 2019

Outcome Measures

Primary Outcomes (1)

• Time to intubation for McGrath videolaryngoscope versus direct laryngoscope

  The time to intubation starts from the time the anesthetist takes over the laryngoscope till the first appearance of consecutive capnography tracings. The time to intubation will be assessed via a retrospective playback of the video-recording of the intubation process. Compares the time to intubation for McGrath videolaryngoscope against direct laryngoscope.

  During the intubation process

Secondary Outcomes (8)

• Incidence of success at first intubation attempt with McGrath videolaryngoscope versus direct laryngoscope

  During the intubation process

• Incidence of the use of adjuncts at first attempt with McGrath videolaryngoscope versus direct laryngoscope

  During the intubation process

• Incidence of the use of adjuncts at subsequent attempts with McGrath videolaryngoscope versus direct laryngoscope

  During the intubation process

• Incidence of success and failure at intubation using initial laryngoscope

  During the intubation process

• Intubation Difficulty Scale with McGrath videolaryngoscope versus direct laryngoscope

  During the intubation process

Study Arms (2)

McGrath videolaryngoscope

ACTIVE COMPARATOR

Anesthetists randomized to this group will intubate patients using the McGrath videolaryngoscope

Device: McGrath videolaryngoscope

Direct laryngoscope

ACTIVE COMPARATOR

Anesthetists randomized to this group will intubate patients using the direct laryngoscope

Device: Direct laryngoscope

Interventions

McGrath videolaryngoscope DEVICE

A brand of a commonly-used videolaryngoscope which has a camera at the end of the laryngoscope to visualize the vocal cords

McGrath videolaryngoscope

Direct laryngoscope DEVICE

Classic direct laryngoscope that depends on visualization of the vocal cords by the operator

Direct laryngoscope

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients will be undergoing routine pre-anesthesia assessment (including review of medical conditions and airway anatomy) by the anesthetists in the PEC prior to their planned elective surgeries. During their routine pre-anesthesia assessment, they will also be assessed by a study team member to confirm if they meet the eligibility criteria. If they are eligible for enrollment, a qualified practitioner will take informed consent.
• We will also recruit 10 anesthetists from the Division to perform the intubations. The 10 anaesthetists will have to self-report experience in both the use of McGrath videolaryngoscope (VL) and direct laryngoscope (DL) for intubation (at least 20 successful intubations with McGrath VL or DL).
• years old and above
• Not pregnant
• ASA physical status I, II and III
• BMI less than 35kg/m2
• Elective surgical operations requiring general anesthesia and endotracheal intubation
• Able to give own informed consent
• No features of difficult airway which has to consist all of the following:
• Class I and II on the modified Mallampati classification
• Thyromental distance of 6.5cm and above
• Mouth opening of 3.5cm and above
• Sterno-mental distance of 12.5cm and above
• Qualified anesthetists (associate consultants and above)
• Experience with both the use of McGrath VL and DL for intubation (at least 20 successful intubations using McGrath VL)

You may not qualify if:

• Below 21 years old
• Pregnancy
• ASA status IV and above
• Poorly-controlled cardiorespiratory conditions (such as poorly-controlled asthma with Asthma Control Test ≤ 19, chronic obstructive pulmonary disease GOLD 2 and above, exertional angina, coronary artery disease with active symptoms, heart failure with New York Heart Association Class III and above)
• Body Mass Index ≥ 35 kg/m2
• Emergency operation
• Unable to give own consent
• Any feature of difficult airway which is
• Class III and IV on the Modified Mallampati Classification
• Thyromental distance less than 6.5cm
• Mouth opening less than 3.5cm
• Sterno-mental distance less than 12.5cm
• History of difficult intubation
• Unstable cervical spine
• Non-specialist anesthetist

Sponsors & Collaborators

• Singapore General Hospital: lead
• Duke-NUS Graduate Medical School: collaborator

Study Sites (1)

Singapore General Hospital

Singapore, Singapore

Location

Related Publications (17)

• Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.

  PMID: 32171076 RESULT

• Brewster DJ, Chrimes N, Do TB, Fraser K, Groombridge CJ, Higgs A, Humar MJ, Leeuwenburg TJ, McGloughlin S, Newman FG, Nickson CP, Rehak A, Vokes D, Gatward JJ. Consensus statement: Safe Airway Society principles of airway management and tracheal intubation specific to the COVID-19 adult patient group. Med J Aust. 2020 Jun;212(10):472-481. doi: 10.5694/mja2.50598. Epub 2020 May 1.

  PMID: 32356900 RESULT

• Wax RS, Christian MD. Practical recommendations for critical care and anesthesiology teams caring for novel coronavirus (2019-nCoV) patients. Can J Anaesth. 2020 May;67(5):568-576. doi: 10.1007/s12630-020-01591-x. Epub 2020 Feb 12.

  PMID: 32052373 RESULT

• Zuo MZ, Huang YG, Ma WH, Xue ZG, Zhang JQ, Gong YH, Che L; Chinese Society of Anesthesiology Task Force on Airway Management; Airway Management Chinese Society of Anesthesiology Task Force on. Expert Recommendations for Tracheal Intubation in Critically ill Patients with Noval Coronavirus Disease 2019. Chin Med Sci J. 2020 Feb 27;35(2):105-9. doi: 10.24920/003724. Online ahead of print.

  PMID: 32102726 RESULT

• 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 RESULT

• Chan MT, Chow BK, Chu L, Hui DS. Mask ventilation and dispersion of exhaled air. Am J Respir Crit Care Med. 2013 Apr 1;187(7):e12-4. doi: 10.1164/rccm.201201-0137im. No abstract available.

  PMID: 23540885 RESULT

• Hall D, Steel A, Heij R, Eley A, Young P. Videolaryngoscopy increases 'mouth-to-mouth' distance compared with direct laryngoscopy. Anaesthesia. 2020 Jun;75(6):822-823. doi: 10.1111/anae.15047. Epub 2020 Mar 29. No abstract available.

  PMID: 32221979 RESULT

• Lewis SR, Butler AR, Parker J, Cook TM, Smith AF. Videolaryngoscopy versus direct laryngoscopy for adult patients requiring tracheal intubation. Cochrane Database Syst Rev. 2016 Nov 15;11(11):CD011136. doi: 10.1002/14651858.CD011136.pub2.

  PMID: 27844477 RESULT

• Scales DC, Green K, Chan AK, Poutanen SM, Foster D, Nowak K, Raboud JM, Saskin R, Lapinsky SE, Stewart TE. Illness in intensive care staff after brief exposure to severe acute respiratory syndrome. Emerg Infect Dis. 2003 Oct;9(10):1205-10. doi: 10.3201/eid0910.030525. No abstract available.

  PMID: 14609453 RESULT

• Loeb M, McGeer A, Henry B, Ofner M, Rose D, Hlywka T, Levie J, McQueen J, Smith S, Moss L, Smith A, Green K, Walter SD. SARS among critical care nurses, Toronto. Emerg Infect Dis. 2004 Feb;10(2):251-5. doi: 10.3201/eid1002.030838.

  PMID: 15030692 RESULT

• 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 RESULT

• Altun D, Ali A, Camci E, Ozonur A, Seyhan TO. Haemodynamic Response to Four Different Laryngoscopes. Turk J Anaesthesiol Reanim. 2018 Dec;46(6):434-440. doi: 10.5152/TJAR.2018.59265. Epub 2018 Sep 6.

  PMID: 30505605 RESULT

• Adnet F, Borron SW, Racine SX, Clemessy JL, Fournier JL, Plaisance P, Lapandry C. The intubation difficulty scale (IDS): proposal and evaluation of a new score characterizing the complexity of endotracheal intubation. Anesthesiology. 1997 Dec;87(6):1290-7. doi: 10.1097/00000542-199712000-00005.

  PMID: 9416711 RESULT

• Roth D, Pace NL, Lee A, Hovhannisyan K, Warenits AM, Arrich J, Herkner H. Bedside tests for predicting difficult airways: an abridged Cochrane diagnostic test accuracy systematic review. Anaesthesia. 2019 Jul;74(7):915-928. doi: 10.1111/anae.14608. Epub 2019 Mar 6.

  PMID: 30843190 RESULT

• Cormack RS, Lehane J. Difficult tracheal intubation in obstetrics. Anaesthesia. 1984 Nov;39(11):1105-11.

  PMID: 6507827 RESULT

• Greenland KB, Tsui D, Goodyear P, Irwin MG. Personal protection equipment for biological hazards: does it affect tracheal intubation performance? Resuscitation. 2007 Jul;74(1):119-26. doi: 10.1016/j.resuscitation.2006.11.011. Epub 2007 Mar 13.

  PMID: 17353076 RESULT

• Shin DH, Choi PC, Na JU, Cho JH, Han SK. Utility of the Pentax-AWS in performing tracheal intubation while wearing chemical, biological, radiation and nuclear personal protective equipment: a randomised crossover trial using a manikin. Emerg Med J. 2013 Jul;30(7):527-31. doi: 10.1136/emermed-2012-201463.

  PMID: 23765764 RESULT

Related Links

• Liana Zucco, Nadav Levy, Desire Ketchandji, Mike Aziz, S. K. R. Anesthesia Patient Safety Foundation - Perioperative Considerations for the 2019 Novel Coronavirus (COVID-19)
• Australian Society of Anaesthetists. COVID-19 Updates.

MeSH Terms

Conditions

Coronavirus Infections; Hypoventilation; COVID-19

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases

Study Officials

• Qing Yuan Goh, M.Med (Anes)

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patients who have consented for the operation will not know which laryngoscope (either McGrath videolaryngoscope or direct laryngoscope) was used for their intubation. The outcomes assessor will not know which group the patients and the anesthetists are in when analysing the results.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial. Prior to a consented patient turning up for his/her operation, randomization will be done to determine who from the selected group of anesthetists will be doing the intubation. The randomly selected anesthetist will wear the PAPR and intubate the patient using either a DL or McGrath VL that he/she is randomized to.

Study Record Dates

• First Submitted: June 1, 2020
• First Posted: June 11, 2020
• Study Start: June 1, 2020
• Primary Completion: September 25, 2020
• Study Completion: September 25, 2020
• Last Updated: March 17, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)