Characterizing the Perioperative Epidemiology of SARS-CoV-2 (COVID-19) Spread for Quality Improvement of Perioperative Infection Control Program

NCT04443803 | Completed

• 1 other identifier: 202005391
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Perioperative transmission of SARS-CoV-2

  Sars-CoV-2 transmission event

  24 hours

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing surgery at the University of Iowa

You may qualify if:

• Adult (at least 18 years old) COVID-19 positive patient undergoing surgery requiring anesthesia and placement of a peripheral and/or central intravenous catheter.

You may not qualify if:

• \<18 years old, Shellfish, iodine, chlorhexidine allergies, COVID-19 negative status, no anesthesia and/or placement of peripheral and/or central intravenous catheter required

Sponsors & Collaborators

• Randy Loftus: lead

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Related Publications (1)

• 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.

  PMID: 32219407 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

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.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 19, 2020
• First Posted: June 23, 2020
• Study Start: July 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: July 12, 2021

Record last verified: 2021-07

Locations

US (1)