NCT04665960

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 14, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

March 29, 2021

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2021

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

May 11, 2021

Status Verified

May 1, 2021

Enrollment Period

27 days

First QC Date

December 9, 2020

Last Update Submit

May 9, 2021

Conditions

Keywords

Infection ControlIntensive care unitSARS-CoV-2COVID-19

Outcome Measures

Primary Outcomes (1)

  • 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.

    30 days

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NMC Specialty Hospital

Dubai, 7832, United Arab Emirates

Location

Related Publications (2)

  • 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.

    PMID: 32307115BACKGROUND
  • 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.

    PMID: 32052373BACKGROUND

Related Links

MeSH Terms

Conditions

COVID-19Severe Acute Respiratory SyndromeCoronavirus InfectionsInfections

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Sheila Myatra, MD

    Tata Memorial Hospital, Mumbai, India

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head Critical Care Medicine

Study Record Dates

First Submitted

December 9, 2020

First Posted

December 14, 2020

Study Start

March 29, 2021

Primary Completion

April 25, 2021

Study Completion

May 1, 2021

Last Updated

May 11, 2021

Record last verified: 2021-05

Locations