COVID-19NCT04443803
Characterizing the Perioperative Epidemiology of SARS-CoV-2 (COVID-19) Spread for Quality Improvement of Perioperative Infection Control Program
An observational study of COVID-19, run by Randy Loftus at 1 site in United States.
Trial summary
In a case-series analysis, up to 20 patients undergoing elective or urgent/emergent surgery that are COVID-19 positive will be approached for patient consent. OR PathTrac (RDB Bioinformatics, Omaha, NE 68154) collection kits will be utilized for sampling of 48 sampled time/locations per patient. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- COVID-19
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2020to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing surgery at the University of Iowa
Who may be able to join
- Adult (at least 18 years old) COVID-19 positive patient undergoing surgery requiring anesthesia and placement of a peripheral and/or central intravenous catheter.
Who cannot join
- <18 years old, Shellfish, iodine, chlorhexidine allergies, COVID-19 negative status, no anesthesia and/or placement of peripheral and/or central intravenous catheter required
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
About this study
In a case-series analysis, up to 20 patients undergoing elective or urgent/emergent surgery that are COVID-19 positive will be approached for patient consent.
OR PathTrac (RDB Bioinformatics, Omaha, NE 68154) collection kits will be utilized for sampling of 48 sampled time/locations per patient. Patient sampling locations will include the nasopharynx and oropharynx. Operating room environmental locations will include areas in the patient care arena such as the anesthesia machine. Samples of each location will be obtained before and after treatment with UV-C (Helios, Surfacide), germicidal, ultraviolet light and other infection control practices that are currently in place, such as utilization of preoperative chlorhexidine wipes, nasal iodine, improved hand hygiene, and improved vascular care.
Read more
UV-C light for environmental cleaning is not regulated by the FDA.
Samples will be processed by RT-PCR for presence of SARS-CoV-2 nucleic acid. Positive samples will be sent to Dr. Stanley Perlman's lab to assess viability. Samples will also be assessed for S. aureus as a process control. We will characterize the epidemiology of perioperative SARS-CoV-2 spread as a quality improvement initiative to improve our current perioperative infection control bundle and to serve as the platform for national dissemination of a perioperative COVID-19 defense strategy.
Read the detailed description
The operating room schedule will be reviewed each day by a research assistant for COVID-19 positive patients. Additionally, the research assistant will receive a page for every emergency surgery that takes place in the OR.
OR PathTrac collection kits will be utilized for sampling of 48 specific locations/times throughout each case. These samples include:
- 11 samples that have been routinely used for S. aureus including nasopharyngeal. Normally there are 13, but 2 samples are included in the subsequent environmental locations: the adjustable pressure-limiting valve and agent dial at baseline and case end.
- 1 sample from the endotracheal tube tip at case end, as positive control.
- 12 environmental locations at case end including anesthesia machine and each of the air vents,
- 12 environmental locations matched after environmental cleaning, and
- 12 environmental locations matched after Surfacide Helios UV-C cleaning. The Surfacide Helios UV-C cleaning robots will be used after all normal environmental cleaning of the room has taken place.
A transmission event will be defined as 2 samples with detection of SARS-CoV-2 by RT-PCR, with samples obtained from 2 distinct, epidemiologically-related reservoirs within a surveillance unit. The OR PathTrac software platform will process transmission dynamics in order to continually summarize the epidemiology of SARS-CoV transmission, with results updated daily as case-pair data is continually entered into the program. This information will be continually displayed to identify the most common reservoir of origin, the most common transmission locations (vectors), and involvement of key portals of entry (stopcocks). These will become improvement targets with feedback provided via automated failure mode analysis reports. The research assistants will use the reports to continually optimize the interventions during the observational period. The incidence and epidemiology of transmission will be mapped before and after UV-C treatment and positive samples for SARS-CoV-2 examined for viability by a UIHC laboratory.
- Conditions
- COVID-19
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative transmission of SARS-CoV-2
Sars-CoV-2 transmission event
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start1 Jul 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Randy Loftus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Randy Loftus, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04443803
- Sponsor's protocol ID
- 202005391
- Status last verified
- Jul 2021
- First submitted
- 19 Jun 2020
- Last updated
- 12 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Loftus RW, Dexter F, Goodheart MJ, McDonald M, Keech J, Noiseux N, Pugely A, Sharp W, Sharafuddin M, Lawrence WT, Fisher M, McGonagill P, Shanklin J, Skeete D, Tracy C, Erickson B, Granchi T, Evans L, Schmidt E, Godding J, Brenneke R, Persons D, Herber A, Yeager M, Hadder B, Brown JR. The Effect of Improving Basic Preventive Measures in the Perioperative Arena on Staphylococcus aureus Transmission and Surgical Site Infections: A Randomized Clinical Trial. JAMA Netw Open. 2020 Mar 2;3(3):e201934. doi: 10.1001/jamanetworkopen.2020.1934.
PubMed 32219407
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing the Perioperative Epidemiology of SARS-CoV-2 (COVID-19) Spread for Quality Improvement of Perioperative Infection Control Program
- ClinicalTrials.gov ID
- NCT04443803
- Acronym / sponsor ID
- 202005391
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Randy LoftusUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 23 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In a case-series analysis, up to 20 patients undergoing elective or urgent/emergent surgery that are COVID-19 positive will be approached for patient consent.
OR PathTrac (RDB Bioinformatics, Omaha, NE 68154) collection kits will be utilized for sampling of 48 sampled time/locations per patient. Patient sampling locations will include the nasopharynx and oropharynx. Operating room environmental locations will include areas in the patient care arena such as the anesthesia machine. Samples of each location will be obtained before and after treatment with UV-C (Helios, Surfacide), germicidal, ultraviolet light and other infection control practices that are currently in place, such as utilization of preoperative chlorhexidine wipes, nasal iodine, improved hand hygiene, and improved vascular care.
UV-C light for environmental cleaning is not regulated by the FDA.
Samples will be processed by RT-PCR for presence of SARS-CoV-2 nucleic acid. Positive samples will be sent to Dr. Stanley Perlman's lab to assess viability. Samples will also be assessed for S. aureus as a process control. We will characterize the epidemiology of perioperative SARS-CoV-2 spread as a quality improvement initiative to improve our current perioperative infection control bundle and to serve as the platform for national dissemination of a perioperative COVID-19 defense strategy.
Detailed description
The operating room schedule will be reviewed each day by a research assistant for COVID-19 positive patients. Additionally, the research assistant will receive a page for every emergency surgery that takes place in the OR.
OR PathTrac collection kits will be utilized for sampling of 48 specific locations/times throughout each case. These samples include:
- 11 samples that have been routinely used for S. aureus including nasopharyngeal. Normally there are 13, but 2 samples are included in the subsequent environmental locations: the adjustable pressure-limiting valve and agent dial at baseline and case end.
- 1 sample from the endotracheal tube tip at case end, as positive control.
- 12 environmental locations at case end including anesthesia machine and each of the air vents,
- 12 environmental locations matched after environmental cleaning, and
- 12 environmental locations matched after Surfacide Helios UV-C cleaning. The Surfacide Helios UV-C cleaning robots will be used after all normal environmental cleaning of the room has taken place.
A transmission event will be defined as 2 samples with detection of SARS-CoV-2 by RT-PCR, with samples obtained from 2 distinct, epidemiologically-related reservoirs within a surveillance unit. The OR PathTrac software platform will process transmission dynamics in order to continually summarize the epidemiology of SARS-CoV transmission, with results updated daily as case-pair data is continually entered into the program. This information will be continually displayed to identify the most common reservoir of origin, the most common transmission locations (vectors), and involvement of key portals of entry (stopcocks). These will become improvement targets with feedback provided via automated failure mode analysis reports. The research assistants will use the reports to continually optimize the interventions during the observational period. The incidence and epidemiology of transmission will be mapped before and after UV-C treatment and positive samples for SARS-CoV-2 examined for viability by a UIHC laboratory.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing surgery at the University of Iowa
Key inclusion criteria (1 listed)
- Adult (at least 18 years old) COVID-19 positive patient undergoing surgery requiring anesthesia and placement of a peripheral and/or central intravenous catheter.
Key exclusion criteria (1 listed)
- <18 years old, Shellfish, iodine, chlorhexidine allergies, COVID-19 negative status, no anesthesia and/or placement of peripheral and/or central intravenous catheter required
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Perioperative transmission of SARS-CoV-2
Time frame: 24 hours
Sars-CoV-2 transmission event
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2021.
- Background: PubMed 32219407Loftus RW, Dexter F, Goodheart MJ, McDonald M, Keech J, Noiseux N, Pugely A, Sharp W, Sharafuddin M, Lawrence WT, Fisher M, McGonagill P, Shanklin J, Skeete D, Tracy C, Erickson B, Granchi T, Evans L, Schmidt E, Godding J, Brenneke R, Persons D, Herber A, Yeager M, Hadder B, Brown JR. The Effect of Improving Basic Preventive Measures in the Perioperative Arena on Staphylococcus aureus Transmission and Surgical Site Infections: A Randomized Clinical Trial. JAMA Netw Open. 2020 Mar 2;3(3):e201934. doi: 10.1001/jamanetworkopen.2020.1934.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Randy Loftus at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative transmission of SARS-CoV-2 (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04443803, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2021.