Ventilator-induced Lung Injury Vortex in Patients With SARS-CoV-2

NCT04174313 | Completed Results DMC

• 1 other identifier: Nestor Pistillo
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

The concept of Ventilator-induced Lung Injury Vortex (VILI vortex) has recently been proposed as a progressive lung injury mechanism in which the alveolar stress/strain increases as the ventilable lung "shrinks" (1). This positive feedback inexorably leads to the acceleration of lung damage, with potentially irreversible results. Little is known about the clinical aspects of this condition. Understanding its behavior could contribute to changing its potential devastating impact. The objective of this study is to evaluate the incidence of VILI vortex in patients with acute respiratory syndrome (ARDS) secondary to COVID-19, to establish a connection between this phenomenon and mortality, and to identify the factors that have an impact on its development.

Conditions

ARDS; Mechanical Ventilation Complication; Ventilator-Induced Lung Injury

Outcome Measures

Primary Outcomes (3)

• Number of Participants Who Survived and Died

  The number of patients who died and survived was compared between patients with SARS-CoV-2 who progressed with VILI VORTEX and without VILI VORTEX)

  90 days

• Number of Patients With and Without Refractory Hypoxemia

  The number of patients that evolved with refractory hypoxemia was compared between the patients with SARS-CoV-2 that evolved with VILI VORTEX and without VILI VORTEX) Refractory hypoxemia was defined as PaO2/FiO2 \<100 despite the optimization of mechanical ventilation and prone positioning.

  90 days

• Number of Patients With Complications

  The following variables and complications were also observed during the period of analysis: incidence of pneumonia associated with mechanical ventilation, need for noradrenaline over 0.1 γ/kg/min for more than 24 h, positive blood cultures, accumulated fluid balance, dialysis treatment, clinical and/or echocardiographic evidence of heart failure, lactate ≥2 mmol/L in at least two consecutive samples, presence of persistent fever (≥38º at least once a day for three consecutive days), and the highest value of ferritin, D-dimer, C-reactive protein, troponin I and LDH obtained during the first 14 days of invasive mechanical ventilation. VILI vortex patients had positive blood cultures, moderate to severe shock, persistent fever and fluid balance was considerably more positive.

  90 days

Study Arms (1)

VILI VORTEX and No VILI VORTEX

Measurement of pulmonary pressures and volumes in the same patient

Diagnostic Test: CT scan

Interventions

CT scan DIAGNOSTIC_TEST

Mechanical variables and PaO2/FiO2 were registered daily for 14 days or until initiating assisted ventilation. These data were obtained in passive mechanical conditions. Ventilator-induced lung injury vortex was defined as a progressive increase in driving pressure (ΔP) as Vt remained constant or even decreased. Refractory hypoxemia was defined as PaO2/FiO2 \<100 despite the optimization of mechanical ventilation and prone positioning.

Also known as: Transpulmonary pressures (TP) will be measured

VILI VORTEX and No VILI VORTEX

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with SARS-CoV-2 in mechanical ventilation

You may not qualify if:

• Patients with do-not-resuscitate (DNR) orders and pregnant women. Cardiac arrest before ICU admission. Extra corporeal membrane oxygenation (ECMO) requirement within the first 24 h of ICU admission and chronic obstructive pulmonary disease with gold class 3 or 4, or home oxygen therapy

Sponsors & Collaborators

• Hospital El Cruce: lead

Study Sites (1)

Nestor Pistillo

Avellaneda, Buenos Aires, 1870, Argentina

Location

Related Publications (5)

• Marini JJ, Gattinoni L. Time Course of Evolving Ventilator-Induced Lung Injury: The "Shrinking Baby Lung". Crit Care Med. 2020 Aug;48(8):1203-1209. doi: 10.1097/CCM.0000000000004416.

  PMID: 32697492 BACKGROUND

• Beitler JR, Malhotra A, Thompson BT. Ventilator-induced Lung Injury. Clin Chest Med. 2016 Dec;37(4):633-646. doi: 10.1016/j.ccm.2016.07.004. Epub 2016 Oct 14.

  PMID: 27842744 BACKGROUND

• Gattinoni L, Pesenti A. The concept of "baby lung". Intensive Care Med. 2005 Jun;31(6):776-84. doi: 10.1007/s00134-005-2627-z. Epub 2005 Apr 6.

  PMID: 15812622 BACKGROUND

• Gattinoni L, Tonetti T, Quintel M. Regional physiology of ARDS. Crit Care. 2017 Dec 28;21(Suppl 3):312. doi: 10.1186/s13054-017-1905-9.

  PMID: 29297365 BACKGROUND

• Vasques F, Duscio E, Cipulli F, Romitti F, Quintel M, Gattinoni L. Determinants and Prevention of Ventilator-Induced Lung Injury. Crit Care Clin. 2018 Jul;34(3):343-356. doi: 10.1016/j.ccc.2018.03.004.

  PMID: 29907269 BACKGROUND

MeSH Terms

Conditions

Ventilator-Induced Lung Injury

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Results Point of Contact

• Title: Nestor Pistillo
• Organization: Hospital El Cruce

npistillo@yahoo.com.ar

054 1142109000

Study Officials

• Nestor Pistillo

  Hospital El Cruce

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Intensive Care Unit at Hospital El Cruce

Study Record Dates

• First Submitted: November 20, 2019
• First Posted: November 22, 2019
• Study Start: March 10, 2020
• Primary Completion: March 11, 2021
• Study Completion: June 9, 2021
• Last Updated: August 30, 2021
• Results First Posted: August 30, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)