Clinical trial NCT04665960: Infection Control for Severe Acute Respiratory Syndrome Coronavirus 2
Official title: Expert Statements on Infection Control in Intensive Care Unit for Severe Acute Respiratory Syndrome Coronavirus 2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
SARS-CoV Infection
SARS Pneumonia
Coronavirus Infection
Infection
Keywords: Infection Control
Intensive care unit
SARS-CoV-2
COVID-19
Lead sponsor: NMC Specialty Hospital
Sponsor class: OTHER
First posted: 2020-12-14
Enrollment: 35
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 40 global experts in infectious disease, infection control, sepsis, respiratory failure or public health and involved in the management of COVD-19 will be invited to participate in study through e-mail with final expected participation of 35-40 experts.

Brief summary: The investigators aim to develop expert consensus statements on infection control management of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in intensive care units (ICU).

Detailed description: The COVID-19 pandemic has resulted in a considerable change in the infection control protocols in the hospitals, especially ICU. The ICU management of these patients requires robust infection control measures in order to prevent cross-transmission of SARS-CoV-2 (to healthcare workers (HCWs) and other patients) and hospital acquired bacterial or fungal infections. The understanding of epidemiological characteristics of SARS-CoV-2 and pathophysiology of coronavirus disease 2019 (COVID-19) along with evidence on transmission of SARS-COV-2 in controlled healthcare-setting is still evolving. The mode of transmission of SARS-CoV-2 is airborne, through droplets or fomites. Respiratory interventions performed in these patients in ICU, such as non-invasive ventilation, high flow nasal oxygen or tracheal intubation are considered to be aerosol generating procedures and may lead to airborne transmission of SARS-CoV-2. In the absence of the robust evidence, there are no specific recommendations available on infection control of SARS-CoV-2 in ICU.

The objective of this study is to achieve consensus statements on the infection control management of SARS-CoV-2 in ICU.

The whole process of this study will be done in the form of three-four rounds of Google Forms-based Delphi surveys. The survey questionnaire, will be prepared by the investigators after systematic search of available literature and concern areas in the infection control of SARS-CoV-2 in ICU. The objective is to achieve consensus statements on the infection control management of SARS-CoV-2 in ICU.

The survey questionnaire is divided into five sections: 1.Design and engineering 2.Health-care workers and visitors 3. Personal protective equipment 4. Patient and procedures 5. Disinfection and sterilisation.

The majority of these questionnaire statements are to be rated on Likert scale and others have multiple choices. The participating experts comments and feedback will be collected through comment section after each question in round one. All the subsequent surveys will be iterative and the experts can give their opinion in each round using either open text or directly to steering group of investigators.

Eligibility criteria: Inclusion criteria for participants Health care professionals involved in the management of COVID-19 patients with publications and expertise in infectious disease, infection control, sepsis, respiratory failure or public health.

Exclusion Criteria:

* Those who do not accept the invitation or not meeting any of the inclusion criteria.

Primary outcomes:
measure: Consensus using participating experts opinions.
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Dubai
country: United Arab Emirates
facility: NMC Specialty Hospital
Study officials:
affiliation: Tata Memorial Hospital, Mumbai, India
name: Sheila Myatra, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Odor PM, Neun M, Bampoe S, Clark S, Heaton D, Hoogenboom EM, Patel A, Brown M, Kamming D. Anaesthesia and COVID-19: infection control. Br J Anaesth. 2020 Jul;125(1):16-24. doi: 10.1016/j.bja.2020.03.025. Epub 2020 Apr 8.
citation: Wax RS, Christian MD. Practical recommendations for critical care and anesthesiology teams caring for novel coronavirus (2019-nCoV) patients. Can J Anaesth. 2020 May;67(5):568-576. doi: 10.1007/s12630-020-01591-x. Epub 2020 Feb 12.