NCT04864236

An Isolation Device to Contain Aerosol During Aerosol Generating Procedures in the Operating Room

Completed NA Results posted Last updated 21 October 2022

What this trial tests

NA trial testing Novel isolation device to contain aerosol in Aerosol Containment in 79 participants. Completed in 1 September 2021.

Timeline

29 June 2021

Primary endpoint
1 September 2021

1 September 2021

Quick facts

Lead sponsor	John Shin
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	79
Start date	29 June 2021
Primary completion	1 September 2021
Estimated completion	1 September 2021
Sites	1 location across United States

Drugs / interventions tested

• Novel isolation device to contain aerosol

Conditions studied

• Aerosol Containment — all drugs for Aerosol Containment →
• Aerosol Generating Procedure — all drugs for Aerosol Generating Procedure →

Sponsor

John Shin

Who can join

18 and older, any sex, with Aerosol Containment or Aerosol Generating Procedure. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Particle Count Measurements During Intubation Primary · 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

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)

Deep breathing/coughing phase, patient location

Group	Value	95% CI
Intervention Group	4026	1778 – 7616
Control Group	411	211 – 987

Deep breathing/coughing phase, physician location

Group	Value	95% CI
Intervention Group	105	37 – 232
Control Group	392	207 – 1259

Deep breathing/coughing phase, assistant location

Group	Value	95% CI
Intervention Group	74	18 – 211
Control Group	185	98 – 302

Intubation phase, patient location

Group	Value	95% CI
Intervention Group	1560	728 – 3093
Control Group	490	235 – 1394

Intubation phase, physician location

Group	Value	95% CI
Intervention Group	48	15 – 145
Control Group	556	297 – 1579

Intubation phase, assistant location

Group	Value	95% CI
Intervention Group	27	5 – 80
Control Group	218	158 – 436

Time to Intubation Secondary · during intubation

defined as time from the first entry of laryngoscope into pt's oropharynx to the time of confirmed successful tracheal intubation

Group	Value	95% CI
Intervention Group	51.6	± 22.2
Control Group	41.8	± 25.7

Total Number of Intubation Attempts Secondary · during intubation

total number of intubation attempts during airway management

Group	Value	95% CI
Intervention Group	1.05	± 0.22
Control Group	1.08	± 0.27

Pre-operative Airway Assessment (Mallampati Score) Secondary · pre-operative assessment

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

Group	Value	95% CI
Intervention Group	1.74	± 0.68
Control Group	1.53	± 0.72

Laryngoscopy Grade View (Cormack-Lehane) Obtained During Intubation Secondary · 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

Group	Value	95% CI
Intervention Group	1.21	± 0.41
Control Group	1.10	± 0.30

Pre-operative Airway Assessment (Thyromental Distance) Secondary · pre-operative assessment

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.

Group	Value	95% CI
Intervention Group	3.10	± 0.38
Control Group	3.18	± 0.45

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A novel negative pressure isolation device reduces aerosol exposure: A randomized controlled trial.
   Shin JS, Niu M, Chen H, Grogan T, et al · · 2023 · cited 1× · PMID 38621006 · DOI 10.1016/j.tacc.2023.101229