Trial Outcomes & Findings for An Isolation Device to Contain Aerosol During Aerosol Generating Procedures in the Operating Room (NCT NCT04864236)
NCT ID: NCT04864236
Last Updated: 2022-10-21
Results Overview
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)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
79 participants
Primary outcome timeframe
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
Results posted on
2022-10-21
Participant Flow
Participant milestones
| Measure |
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.
|
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.
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|---|---|---|
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Overall Study
STARTED
|
39
|
40
|
|
Overall Study
COMPLETED
|
39
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Intervention Group
n=39 Participants
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.
|
Control Group
n=40 Participants
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.
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=79 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=39 Participants
|
22 Participants
n=40 Participants
|
53 Participants
n=79 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=39 Participants
|
18 Participants
n=40 Participants
|
26 Participants
n=79 Participants
|
|
Age, Continuous
|
51.7 years
STANDARD_DEVIATION 16.0 • n=39 Participants
|
54.1 years
STANDARD_DEVIATION 19.3 • n=40 Participants
|
52.9 years
STANDARD_DEVIATION 17.7 • n=79 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=39 Participants
|
20 Participants
n=40 Participants
|
43 Participants
n=79 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=39 Participants
|
20 Participants
n=40 Participants
|
36 Participants
n=79 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
39 participants
n=39 Participants
|
40 participants
n=40 Participants
|
79 participants
n=79 Participants
|
PRIMARY outcome
Timeframe: 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 totalparticle 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)
Outcome measures
| Measure |
Intervention Group
n=39 Participants
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.
|
Control Group
n=40 Participants
This group will undergo airway management as described for the intervention group, except that SLACC device will not be used.
|
|---|---|---|
|
Particle Count Measurements During Intubation
Deep breathing/coughing phase, patient location
|
4026 particles/cm^3
Interval 1778.0 to 7616.0
|
411 particles/cm^3
Interval 211.0 to 987.0
|
|
Particle Count Measurements During Intubation
Deep breathing/coughing phase, physician location
|
105 particles/cm^3
Interval 37.0 to 232.0
|
392 particles/cm^3
Interval 207.0 to 1259.0
|
|
Particle Count Measurements During Intubation
Deep breathing/coughing phase, assistant location
|
74 particles/cm^3
Interval 18.0 to 211.0
|
185 particles/cm^3
Interval 98.0 to 302.0
|
|
Particle Count Measurements During Intubation
Intubation phase, patient location
|
1560 particles/cm^3
Interval 728.0 to 3093.0
|
490 particles/cm^3
Interval 235.0 to 1394.0
|
|
Particle Count Measurements During Intubation
Intubation phase, physician location
|
48 particles/cm^3
Interval 15.0 to 145.0
|
556 particles/cm^3
Interval 297.0 to 1579.0
|
|
Particle Count Measurements During Intubation
Intubation phase, assistant location
|
27 particles/cm^3
Interval 5.0 to 80.0
|
218 particles/cm^3
Interval 158.0 to 436.0
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SECONDARY outcome
Timeframe: during intubationdefined as time from the first entry of laryngoscope into pt's oropharynx to the time of confirmed successful tracheal intubation
Outcome measures
| Measure |
Intervention Group
n=39 Participants
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.
|
Control Group
n=40 Participants
This group will undergo airway management as described for the intervention group, except that SLACC device will not be used.
|
|---|---|---|
|
Time to Intubation
|
51.6 seconds
Standard Deviation 22.2
|
41.8 seconds
Standard Deviation 25.7
|
SECONDARY outcome
Timeframe: during intubationtotal number of intubation attempts during airway management
Outcome measures
| Measure |
Intervention Group
n=39 Participants
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.
|
Control Group
n=40 Participants
This group will undergo airway management as described for the intervention group, except that SLACC device will not be used.
|
|---|---|---|
|
Total Number of Intubation Attempts
|
1.05 number of attempts
Standard Deviation 0.22
|
1.08 number of attempts
Standard Deviation 0.27
|
SECONDARY outcome
Timeframe: pre-operative assessmentMallampati 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
Outcome measures
| Measure |
Intervention Group
n=39 Participants
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.
|
Control Group
n=40 Participants
This group will undergo airway management as described for the intervention group, except that SLACC device will not be used.
|
|---|---|---|
|
Pre-operative Airway Assessment (Mallampati Score)
|
1.74 score on a scale
Standard Deviation 0.68
|
1.53 score on a scale
Standard Deviation 0.72
|
SECONDARY outcome
Timeframe: during intubationCormack-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
Outcome measures
| Measure |
Intervention Group
n=39 Participants
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.
|
Control Group
n=40 Participants
This group will undergo airway management as described for the intervention group, except that SLACC device will not be used.
|
|---|---|---|
|
Laryngoscopy Grade View (Cormack-Lehane) Obtained During Intubation
|
1.21 score on a scale
Standard Deviation 0.41
|
1.10 score on a scale
Standard Deviation 0.30
|
SECONDARY outcome
Timeframe: pre-operative assessmentthyromental 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.
Outcome measures
| Measure |
Intervention Group
n=39 Participants
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.
|
Control Group
n=40 Participants
This group will undergo airway management as described for the intervention group, except that SLACC device will not be used.
|
|---|---|---|
|
Pre-operative Airway Assessment (Thyromental Distance)
|
3.10 finger breadths
Standard Deviation 0.38
|
3.18 finger breadths
Standard Deviation 0.45
|
Adverse Events
Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
John Shin MD, Associate Clinical Professor
UCLA Anesthesiology
Phone: 310-267-6629
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place