NCT04819165

Brief Summary

In patients who develop ARDS due to SARS-CoV-2 (CARDS), a longer duration of invasive mechanical ventilation (IMV) and ICU stay has been reported compared to ARDS not associated with SARS-CoV-2. Consequently, the days of stay in ICU increase Identifying the risk factors associated with the development of this complication and developing measures aimed at its prevention could have a favorable impact on the clinical course of seriously ill patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
252

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

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

Study Start

First participant enrolled

March 1, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 26, 2021

Completed
Last Updated

March 26, 2021

Status Verified

March 1, 2021

Enrollment Period

10 months

First QC Date

March 25, 2021

Last Update Submit

March 25, 2021

Conditions

Respiration, ArtificialCOVID-19Health Care Associated Infection

Outcome Measures

Primary Outcomes (1)

  • Incidence of health care associated infections in each group.

    March to December 2020

Secondary Outcomes (5)

  • The most frequent pathogens in this population associated with Incidence of health care associated infections.

    March to December 2020

  • Possible factors associated with Incidence of health care associated infections.

    March to December 2020

  • mortality in UCI

    March to December 2020

  • Days of ICU stay

    March to December 2020

  • Days of mechanical ventilation

    March to December 2020

Study Arms (2)

COVID-19 patients

Patients with invasive mechanical ventilation admitted to the Intensive Care Unit (UCI) of the Anchorena San Martín Clinic, San Martín, Buenos Aires with confirmed COVID-19 diagnosis (positive polymerase chain reaction in nasopharyngeal swab).

Other: COVID-19

non COVID-19 patients

Patients with invasive mechanical ventilation admitted to the Intensive Care Unit (UCI) of the Anchorena San Martín Clinic, San Martín, Buenos Aires with negative COVID-19 diagnosis (positive polymerase chain reaction in nasopharyngeal swab).

Interventions

COVID-19OTHER

Impact of covid-19 on infections associated with health care devices.

COVID-19 patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to ICU who required invasive mechanical ventilation during the COVID-19 pandemic from March to December 2020.

You may qualify if:

  • All patients older than 18 years admitted to the intensive care unit of the Anchorena San Martín Clinic who required invasive mechanical ventilation for more than 24 hours in a period between March 2020 and December 2020 were included in the analysis.

You may not qualify if:

  • All patients who presented incomplete data in the follow-up sheets were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanatorio Anchorena de San Martin

San Martín, Buenos Aires, B1650CQU, Argentina

Location

Related Publications (8)

  • Tufan A, Avanoglu Guler A, Matucci-Cerinic M. COVID-19, immune system response, hyperinflammation and repurposing antirheumatic drugs. Turk J Med Sci. 2020 Apr 21;50(SI-1):620-632. doi: 10.3906/sag-2004-168.

    PMID: 32299202RESULT

  • Ripa M, Galli L, Poli A, Oltolini C, Spagnuolo V, Mastrangelo A, Muccini C, Monti G, De Luca G, Landoni G, Dagna L, Clementi M, Rovere Querini P, Ciceri F, Tresoldi M, Lazzarin A, Zangrillo A, Scarpellini P, Castagna A; COVID-BioB study group. Secondary infections in patients hospitalized with COVID-19: incidence and predictive factors. Clin Microbiol Infect. 2021 Mar;27(3):451-457. doi: 10.1016/j.cmi.2020.10.021. Epub 2020 Oct 24.

    PMID: 33223114RESULT

  • Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291.

    PMID: 26903337RESULT

  • Kalanuria AA, Ziai W, Mirski M. Ventilator-associated pneumonia in the ICU. Crit Care. 2014 Mar 18;18(2):208. doi: 10.1186/cc13775. No abstract available.

    PMID: 25029020RESULT

  • Rouze A, Nseir S. Continuous control of tracheal cuff pressure for the prevention of ventilator-associated pneumonia in critically ill patients: where is the evidence? Curr Opin Crit Care. 2013 Oct;19(5):440-7. doi: 10.1097/MCC.0b013e3283636b71.

    PMID: 23856895RESULT

  • Duszynska W, Rosenthal VD, Szczesny A, Woznica E, Ulfik K, Ostrowska E, Litwin A, Kubler A. Urinary tract infections in intensive care unit patients - a single-centre, 3-year observational study according to the INICC project. Anaesthesiol Intensive Ther. 2016;48(1):1-6. doi: 10.5603/AIT.2016.0001.

    PMID: 26966105RESULT

  • Rosenthal VD, Dwivedy A, Calderon ME, Esen S, Hernandez HT, Abouqal R, Medeiros EA, Espinoza TA, Kanj SS, Gikas A, Barnett AG, Graves N; International Nosocomial Infection Control Consortium (INICC) Members. Time-dependent analysis of length of stay and mortality due to urinary tract infections in ten developing countries: INICC findings. J Infect. 2011 Feb;62(2):136-41. doi: 10.1016/j.jinf.2010.12.004. Epub 2010 Dec 17.

    PMID: 21168440RESULT

  • Rouze A, Martin-Loeches I, Povoa P, Makris D, Artigas A, Bouchereau M, Lambiotte F, Metzelard M, Cuchet P, Boulle Geronimi C, Labruyere M, Tamion F, Nyunga M, Luyt CE, Labreuche J, Pouly O, Bardin J, Saade A, Asfar P, Baudel JL, Beurton A, Garot D, Ioannidou I, Kreitmann L, Llitjos JF, Magira E, Megarbane B, Meguerditchian D, Moglia E, Mekontso-Dessap A, Reignier J, Turpin M, Pierre A, Plantefeve G, Vinsonneau C, Floch PE, Weiss N, Ceccato A, Torres A, Duhamel A, Nseir S; coVAPid study Group. Relationship between SARS-CoV-2 infection and the incidence of ventilator-associated lower respiratory tract infections: a European multicenter cohort study. Intensive Care Med. 2021 Feb;47(2):188-198. doi: 10.1007/s00134-020-06323-9. Epub 2021 Jan 3.

    PMID: 33388794RESULT

MeSH Terms

Conditions

Respiratory AspirationCOVID-19Cross Infection

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesIatrogenic DiseaseDisease Attributes

Study Officials

  • matias accoce

    SAnchorena San Martin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RT

Study Record Dates

First Submitted

March 25, 2021

First Posted

March 26, 2021

Study Start

March 1, 2020

Primary Completion

December 31, 2020

Study Completion

January 31, 2021

Last Updated

March 26, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

AR(1)