Clinical Evaluation of an Airborne Pathogen Containment Device: Randomized Open-label Equivalence Trial During Endotracheal Intubation

NCT06968377 | Recruiting DMC

• 3 other identifiers: 10279831026879381288
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to test a bubble-like dome (made of clear plastic) being placed over patients' heads during surgery as a tool to prevent the spread of germs through the air in hospitals. The researchers are interested in the following outcomes:

• How the device affects the patients' experience of surgery.
• The impact of the device on how long it takes to place a breathing tube, blood pressure, heart rate and oxygen levels of the patient. Researchers will compare the outcomes across patients using the device and patients not using the device. This will be done by randomly (by chance) assigning participants undergoing surgery to group 1 (using the bubble-like dome device) or group 2 (not using the device). Participants will:
• Tell the researchers or your anesthesia doctor about any problems that you experience that you think might be related to participating in the study.
• Fill out a 10-minute survey regarding your experience with the dome after surgery.
• If you did not try the dome before going to sleep, you will be able to watch a video of the dome in use and answer questions based on the video
• Be video recorded with your time with the dome.

Conditions

Medical Device; Medical Device Performance; Aerosol Generating Procedure

Outcome Measures

Primary Outcomes (1)

• Duration of time needed to place an airway (seconds)

  Difference in means of airway times with and without the device present.

  Day of surgery (intubation)

Secondary Outcomes (2)

• First pass intubation success rate (%)

  Day of Surgery - intubation (indicated by the moment the laryngoscope tip first touches the patient's mouth)

• Incidence of SaO2 <90%

  During time spent in surgical recovery room

Other Outcomes (5)

• Mean nadir ETO2 (%)

  within 1 minute of delivery of first breath post-intubation

• Mean nadir ETCO2 (%)

  Within 1 minute of first breath through endotracheal tube.

• Device satisfaction survey score

  Day of surgery

Study Arms (2)

Dome

EXPERIMENTAL

The device is a large, bubble-like dome made of clear plastic through which doctor and nurse can care for the patient during surgery.

Device: A novel airborne pathogen containment device.

No dome

NO INTERVENTION

Standard care during surgery.

Interventions

A novel airborne pathogen containment device. DEVICE

The dome is placed over the patient's head during the full duration of a surgery (intubation and extubation included) as a method of preventing infection transmission through airborne aerosols throughout a hospital.

Dome

Eligibility Criteria

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

You may qualify if:

• ASA class 1 and 2
• Elective surgery
• Adults \>18 years of age
• Ability to give informed consent
• Surgery in supine or lithotomy position
• Surgical site: abdominal, pelvic, lower limb or distal upper limb
• Endotracheal intubation is indicated as per attending anesthesiologist

You may not qualify if:

• BMI \>40
• pregnancy
• "full stomach" or increased intraabdominal pressure (as per attending anesthesiologist)
• predictors of difficult airway management as per attending anesthesiologist
• airway management plan (as per attending anesthesiologist) that is incompatible with study protocol
• initial ventilatory settings that are incompatible with planned care as per study protocol
• Claustrophobia
• significant cardiovascular or respiratory disease (including pleural effusion, pulmonary edema, etc.)
• anticipated significant level of post-operative sedation preventing survey participation

Sponsors & Collaborators

• IWK Health Centre: lead

Study Sites (1)

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

RECRUITING

Related Publications (6)

• Fong S, Li E, Violato E, Reid A, Gu Y. Impact of aerosol box on intubation during COVID-19: a simulation study of normal and difficult airways. Can J Anaesth. 2021 Apr;68(4):496-504. doi: 10.1007/s12630-020-01825-y. Epub 2020 Oct 9.

  PMID: 33033956 BACKGROUND

• Begley JL, Lavery KE, Nickson CP, Brewster DJ. The aerosol box for intubation in coronavirus disease 2019 patients: an in-situ simulation crossover study. Anaesthesia. 2020 Aug;75(8):1014-1021. doi: 10.1111/anae.15115. Epub 2020 Jun 1.

  PMID: 32397008 BACKGROUND

• Labaste F, Ferre F, Combelles H, Rey V, Foissac JC, Senechal A, Conil JM, Minville V. Validation of a visual analogue scale for the evaluation of the postoperative anxiety: A prospective observational study. Nurs Open. 2019 Jul 11;6(4):1323-1330. doi: 10.1002/nop2.330. eCollection 2019 Oct.

  PMID: 31660159 BACKGROUND

• Casey JD, Semler MW. Beginning of the End? End-tidal Oxygen as an Outcome in Airway Management Research. EClinicalMedicine. 2019 Jul 24;13:10-11. doi: 10.1016/j.eclinm.2019.07.006. eCollection 2019 Aug. No abstract available.

  PMID: 31517257 BACKGROUND

• Wang J, Du G. COVID-19 may transmit through aerosol. Ir J Med Sci. 2020 Nov;189(4):1143-1144. doi: 10.1007/s11845-020-02218-2. Epub 2020 Mar 24. No abstract available.

  PMID: 32212099 BACKGROUND

• Sjaus A, d'Entremont M. Measurement of airborne particle exposure during simulated tracheal intubation using various proposed aerosol containment devices during the COVID-19 pandemic. Anaesthesia. 2021 Mar;76 Suppl 3(Suppl 3):7-8. doi: 10.1111/anae.15227. Epub 2020 Aug 1. No abstract available.

  PMID: 32737982 BACKGROUND

Central Study Contacts

Ana Sjaus, MSc, MD, FRCPC

CONTACT

1-902-470-6627; anesthesiaresearch@iwk.nshealth.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief, Department of Women's & Obstetric Anesthesia, IWK Health Centre

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 13, 2025
• Study Start: January 7, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: September 16, 2026

Record last verified: 2026-09

Locations

CA (1)