Covid19IC-COVID-19NCT04665960
Infection Control for Severe Acute Respiratory Syndrome Coronavirus 2
An observational study of Covid19 and SARS-CoV Infection, run by NMC Specialty Hospital at 1 site in United Arab Emirates.
Trial 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). Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Covid19, SARS-CoV Infection, SARS Pneumonia
- How many people
- 35 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 29 Mar 2021to 1 May 2021
- 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 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
None listed.
Who cannot join
- Those who do not accept the invitation or not meeting any of the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Expert Statements on Infection Control in Intensive Care Unit for Severe Acute Respiratory Syndrome Coronavirus 2
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).
Read the 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.
- Conditions
- Covid19, SARS-CoV Infection, SARS Pneumonia, Coronavirus Infection, Infection
- Keywords
- Infection Control, Intensive care unit, SARS-CoV-2, COVID-19
- Medical subject headings
- COVID-19, Severe Acute Respiratory Syndrome, Coronavirus Infections, Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Consensus using participating experts opinions.
For statements with responses on an ordinal 7-point Likert scale, 'agreement' is defined as a score of 5-7, 'neutral' by a score of 4 and 'disagreement' by a score of 1-3. Consensus is defined as achieved when >70% of the experts voted for a given option in Likert scale statement. Median and interquartile range (IQR) were used to describe the central tendency and dispersion of responses. For multiple-choice questions (MCQs), consensus is defined as achieved if >80% of the experts voted for a particular option.
Stability in the responses will be assessed from round two onwards. Stability will be assessed between the two concluding rounds for each statement, using the non-parametric chi square (χ2) test. p < 0·05 is considered as a significant variation or unstable.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start29 Mar 2021
- Primary completion25 Apr 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- NMC Specialty Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prashant Nasa, NMC Specialty Hospital
- Investigators
- Sheila Myatra, MD, Principal investigator, Tata Memorial Hospital, Mumbai, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04665960
- Sponsor's protocol ID
- NMCSpecialtyH
- Acronym
- IC-COVID-19
- Status last verified
- May 2021
- First submitted
- 9 Dec 2020
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32307115Wax 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.
PubMed 32052373
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expert Statements on Infection Control in Intensive Care Unit for Severe Acute Respiratory Syndrome Coronavirus 2
- ClinicalTrials.gov ID
- NCT04665960
- Acronym / sponsor ID
- IC-COVID-19 / NMCSpecialtyH
- Conditions
- Covid19, SARS-CoV Infection, SARS Pneumonia, Coronavirus Infection, Infection
- Keywords
- Infection Control, Intensive care unit, SARS-CoV-2, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- NMC Specialty HospitalUniversity, hospital or other
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 25 Apr 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 14 Dec 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Those who do not accept the invitation or not meeting any of the inclusion criteria.
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
Consensus using participating experts opinions.
Time frame: 30 days
For statements with responses on an ordinal 7-point Likert scale, 'agreement' is defined as a score of 5-7, 'neutral' by a score of 4 and 'disagreement' by a score of 1-3. Consensus is defined as achieved when >70% of the experts voted for a given option in Likert scale statement. Median and interquartile range (IQR) were used to describe the central tendency and dispersion of responses. For multiple-choice questions (MCQs), consensus is defined as achieved if >80% of the experts voted for a particular option. Stability in the responses will be assessed from round two onwards. Stability will be assessed between the two concluding rounds for each statement, using the non-parametric chi square (χ2) test. p < 0·05 is considered as a significant variation or unstable.
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 11 May 2021.
- Background: PubMed 32307115Odor 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.
- Background: PubMed 32052373Wax 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.
- Center for Disease Control and Prevention (CDC). Interim Infection Prevention and Control Recommendations for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic. Updated November 4, 2020.Link provided by the sponsor.
- World Health Organisation (WHO). Infection prevention and control guidance - (COVID-19). Updated September 11, 2020.Link provided by the sponsor.
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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.
Sheila Myatra, MD principal investigator
Tata Memorial Hospital, Mumbai, India
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 Covid19 and SARS-CoV Infection, run by NMC Specialty Hospital at 1 site in United Arab Emirates.
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 0 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 11 May 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 Arab Emirates. 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?
Consensus using participating experts opinions. (time frame: 30 days). 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 NCT04665960, which also lists 2 linked publications.
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 11 May 2021.