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The purpose of this study is to test the safety and efficacy of a new isolation device to contain aerosol during aerosol-generating procedures in the operating room.
Patients with SARS-CoV-2 infections may require procedures that generate infectious aerosols (suspension of tiny particles or droplets in the air). Aerosols are believed to be the primary method of spread of SARS-CoV-2, as well as many other communicable diseases. In the health care setting, the providers who are in close proximity to patients during these aerosol-generating procedures (ie. Intubation (tube in your throat to help you breathe), noninvasive positive pressure ventilation (breathing support administered through a face or nasal mask) methods such as continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP), bronchoscopy (thin tube through nose or mouth into the lungs), high flow nasal cannula (oxygen delivery through the nose at a very high flow rate)) are at risk for becoming infected with SARS-CoV-2. The current standard of care to prevent the spread of virus to health care workers involves the use of N-95 respirators (particulate filtering facepiece respirators), which have been intermittently in short supply throughout the current COVID-19 pandemic. In addition, even when there are adequate supplies of N-95 respirators, health care workers have been reusing the respirators multiple times, which may result in decreased efficacy and potential viral exposure. In order to provide enhanced protection to health care workers during aerosol-generating procedures, the study investigators have created a device, named SLACC (Suction-assisted Local Aerosol Containment Chamber). SLACC has the ability to isolate the atmosphere around the patient's upper airway (nose, mouth, throat) via negative pressure in a manner analogous to isolation rooms used to house patients with communicable diseases spread by aerosol (e.g. tuberculosis). Furthermore, SLACC is inexpensive, portable, and relatively simple to manufacture.
The SLACC uses an external suction source to maintain a negative pressure micro-atmosphere around a patient's head (the source of infectious aerosols). The components of SLACC include a clear polymer frame, a flexible drape, and integrated sealed arm sleeves to protect the hands and forearms of the health care provider. The structure is flexible during use, transparent, can be rapidly assembled, and easily collapsible for removal and transport. It is assembled using adhesive-backed polymer sections, allowing the structure to fold from a flat shipping/storage conformation into a free-standing structure. Once deployed with the patient's head inside the chamber, the drape is secured across the open side of the chamber with adhesive and covers the patient's torso. Many other containment devices have been proposed during the COVID-19 pandemic, but none have been demonstrated to contain aerosols effectively. With external suction applied, the investigators believe SLACC vastly improves upon the aerosol containment ability of other devices. The investigators have tested SLACC in a simulated setting and recently published the results in a high-quality, peer-reviewed journal (PMID: 32541251).
The investigators propose to test the safety and efficacy of SLACC in containing contamination during aerosol-generating procedures in the operating room through a randomized controlled trial. The investigators have identified a method of objectively quantifying health care worker exposure to respiratory particles and plan to compare exposure to the number and size of respiratory particles when SLACC is used compared to the current standard of care (no device used).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | This group will undergo airway management in the operating room as part of the anesthesia for surgery in the presence of the novel isolation device. |
|
| Control group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novel isolation device to contain aerosol | Device | The novel isolation device is called SLACC (Suction-assisted Local Aerosol Containment Chamber). SLACC has the ability to isolate the atmosphere around the patient's upper airway (nose, mouth, throat) via negative pressure in a manner analogous to isolation rooms used to house patients with communicable diseases spread by aerosol (e.g. tuberculosis). The SLACC uses an external suction source to maintain a negative pressure micro-atmosphere around a patient's head (the source of infectious aerosols). The components of SLACC include a clear polymer frame, a flexible drape, and integrated sealed arm sleeves to protect the hands and forearms of the health care provider. The structure is flexible during use, transparent, can be rapidly assembled, and easily collapsible for removal and transport. Once deployed with the patient's head inside the chamber, the drape is secured across the open side of the chamber with adhesive and covers the patient's torso. |
| Measure | Description | Time Frame |
|---|---|---|
| Particle Count Measurements During Intubation | particle counts will be measured using a commercially-available particle counter at two locations: at the level of the anesthesiology provider's face (at the patient's head), and at the level of the assistant provider's face (at the patient's side) | particle counts will be measured continuously from the time of patient's entry into the operating room until the patient has been intubated for surgery, approximately 15 minutes total |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Intubation | defined as time from the first entry of laryngoscope into pt's oropharynx to the time of confirmed successful tracheal intubation | during intubation |
| Total Number of Intubation Attempts |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Shin, MD | University of California Los Angeles Department of Anesthesiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Medical Center | Los Angeles | California | 90095 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32541251 | Background | Seger CD, Wang L, Dong X, Tebon P, Kwon S, Liew EC, Marijic J, Umar S, Hoftman NN. A Novel Negative Pressure Isolation Device for Aerosol Transmissible COVID-19. Anesth Analg. 2020 Sep;131(3):664-668. doi: 10.1213/ANE.0000000000005052. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group | This group will undergo airway management in the operating room as part of the anesthesia for surgery in the presence of the novel isolation device. Novel isolation device to contain aerosol: The novel isolation device is called SLACC (Suction-assisted Local Aerosol Containment Chamber). SLACC has the ability to isolate the atmosphere around the patient's upper airway (nose, mouth, throat) via negative pressure in a manner analogous to isolation rooms used to house patients with communicable diseases spread by aerosol (e.g. tuberculosis). The SLACC uses an external suction source to maintain a negative pressure micro-atmosphere around a patient's head (the source of infectious aerosols). The components of SLACC include a clear polymer frame, a flexible drape, and integrated sealed arm sleeves to protect the hands and forearms of the health care provider. The structure is flexible during use, transparent, can be rapidly assembled, and easily collapsible for removal and transport. Once deployed with the patient's head inside the chamber, the drape is secured across the open side of the chamber with adhesive and covers the patient's torso. |
| FG001 | Control Group | This group will undergo airway management in the same manner as described for the intervention group except that there is no SLACC device. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group | This group will undergo airway management in the operating room as part of the anesthesia for surgery in the presence of the novel isolation device. Novel isolation device to contain aerosol: The novel isolation device is called SLACC (Suction-assisted Local Aerosol Containment Chamber). SLACC has the ability to isolate the atmosphere around the patient's upper airway (nose, mouth, throat) via negative pressure in a manner analogous to isolation rooms used to house patients with communicable diseases spread by aerosol (e.g. tuberculosis). The SLACC uses an external suction source to maintain a negative pressure micro-atmosphere around a patient's head (the source of infectious aerosols). The components of SLACC include a clear polymer frame, a flexible drape, and integrated sealed arm sleeves to protect the hands and forearms of the health care provider. The structure is flexible during use, transparent, can be rapidly assembled, and easily collapsible for removal and transport. Once deployed with the patient's head inside the chamber, the drape is secured across the open side of the chamber with adhesive and covers the patient's torso. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Particle Count Measurements During Intubation | particle counts will be measured using a commercially-available particle counter at two locations: at the level of the anesthesiology provider's face (at the patient's head), and at the level of the assistant provider's face (at the patient's side) | Posted | Median | Inter-Quartile Range | particles/cm^3 | particle counts will be measured continuously from the time of patient's entry into the operating room until the patient has been intubated for surgery, approximately 15 minutes total |
|
Adverse event data was collected over the course of the patient's participation in the trial, which ended approximately 4 minutes after intubation (when all data stopped being collected). The course of a typical patient's participation in the trial averaged approximately 15 min.
Additional adverse event data collected included failure to intubate and failure to complete airway management in the intervention group for any reason (patient refusal, surgeon refusal, anesthesiologist's clinical judgment).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group | This group will undergo airway management in the operating room as part of the anesthesia for surgery in the presence of the novel isolation device. Novel isolation device to contain aerosol: The novel isolation device is called SLACC (Suction-assisted Local Aerosol Containment Chamber). SLACC has the ability to isolate the atmosphere around the patient's upper airway (nose, mouth, throat) via negative pressure in a manner analogous to isolation rooms used to house patients with communicable diseases spread by aerosol (e.g. tuberculosis). The SLACC uses an external suction source to maintain a negative pressure micro-atmosphere around a patient's head (the source of infectious aerosols). The components of SLACC include a clear polymer frame, a flexible drape, and integrated sealed arm sleeves to protect the hands and forearms of the health care provider. The structure is flexible during use, transparent, can be rapidly assembled, and easily collapsible for removal and transport. Once deployed with the patient's head inside the chamber, the drape is secured across the open side of the chamber with adhesive and covers the patient's torso. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Shin MD, Associate Clinical Professor | UCLA Anesthesiology | 310-267-6629 | JShin@mednet.ucla.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 28, 2021 | Sep 23, 2022 | Prot_SAP_001.pdf |
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|
total number of intubation attempts during airway management
| during intubation |
| Pre-operative Airway Assessment (Mallampati Score) | Mallampati score, can be given a score of 1-4 (whole numbers only), score of 4 indicates higher likelihood of difficult intubation and score of 1 indicates lower likelihood of difficult intubation | pre-operative assessment |
| Laryngoscopy Grade View (Cormack-Lehane) Obtained During Intubation | Cormack-Lehane grade assigned by anesthesiologist during intubation, grade can be 1-4, grade 1 correlates with a view of entirety of vocal cords while grade 4 correlates with no view at all of any part of the vocal cords | during intubation |
| Pre-operative Airway Assessment (Thyromental Distance) | thyromental distance is the distance measured between the chin and the thyroid cartilage (both landmarks are readily palpable on physical exam), this distance is typically measured in centimeters or as a measure of the number of finger breadths (as reported here). Finger breadths is defined as the number of finger widths that can fit within the defined distance. | pre-operative assessment |
| BG001 | Control Group | This group will undergo airway management in the operating room in an identical manner to the intervention group except that the SLACC device will not be used. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Control Group | This group will undergo airway management as described for the intervention group, except that SLACC device will not be used. |
|
|
|
| Secondary | Time to Intubation | defined as time from the first entry of laryngoscope into pt's oropharynx to the time of confirmed successful tracheal intubation | Posted | Mean | Standard Deviation | seconds | during intubation |
|
|
|
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| Secondary | Total Number of Intubation Attempts | total number of intubation attempts during airway management | Posted | Mean | Standard Deviation | number of attempts | during intubation |
|
|
|
|
| Secondary | Pre-operative Airway Assessment (Mallampati Score) | Mallampati score, can be given a score of 1-4 (whole numbers only), score of 4 indicates higher likelihood of difficult intubation and score of 1 indicates lower likelihood of difficult intubation | Posted | Mean | Standard Deviation | score on a scale | pre-operative assessment |
|
|
|
|
| Secondary | Laryngoscopy Grade View (Cormack-Lehane) Obtained During Intubation | Cormack-Lehane grade assigned by anesthesiologist during intubation, grade can be 1-4, grade 1 correlates with a view of entirety of vocal cords while grade 4 correlates with no view at all of any part of the vocal cords | Posted | Mean | Standard Deviation | score on a scale | during intubation |
|
|
|
|
| Secondary | Pre-operative Airway Assessment (Thyromental Distance) | thyromental distance is the distance measured between the chin and the thyroid cartilage (both landmarks are readily palpable on physical exam), this distance is typically measured in centimeters or as a measure of the number of finger breadths (as reported here). Finger breadths is defined as the number of finger widths that can fit within the defined distance. | Posted | Mean | Standard Deviation | finger breadths | pre-operative assessment |
|
|
|
|
| 0 |
| 39 |
| 0 |
| 39 |
| 0 |
| 39 |
| EG001 | Control Group | This group will undergo airway management in the same manner as described for the intervention group except that there is no SLACC device. | 0 | 40 | 0 | 40 | 0 | 40 |
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