Comparison of Extra Vascular Lung Water Index in Covid-19 ARDS and "Typical"ARDS Patients

NCT04508933 | Withdrawn FDA Device

• 1 other identifier: 0308202247
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Covid-19 also primarily affects endothelium that line up the alveoli. The resulting hypoxemia may differ from "typical" Acute Respiratory Distress Syndrome (ARDS) due to maldistribution of perfusion related to the ventilation. Thus, pathophysiology of Covid-19 ARDS is different, which requires different interventions than typical ARDS. The investigators will assess whether extravascular lung water index and permeability of the alveolar capillary differs from typical ARDS with transpulmonary thermodilution (TPTD) technique. Extravascular Lung Water Index (EVLWI) and Pulmonary Vascular Permeability Index (PVPI) will be compared.

Conditions

Respiratory Distress Syndrome, Adult; Ventilation Perfusion Mismatch; Pulmonary Edema; Covid19

Keywords

ards; covid19

Outcome Measures

Primary Outcomes (2)

• Extravascular Lung Water Index

  The amount of fluid accumulated in the lung measured by transpulmonary thermodilution (ml/kg)

  1 day

• Pulmonary vascular permeability index

  Integrity of the alveolocapillary barrier measured by transpulmonary thermodilution

  1 day

Study Arms (2)

Typical ARDS

ARDS due to non Covid19 causes

Device: Extravascular Lung Water Index; Device: Pulmonary Vascular Permeability Index

C-ARDS

ARDS due to Covid19

Device: Extravascular Lung Water Index; Device: Pulmonary Vascular Permeability Index

Interventions

Extravascular Lung Water Index DEVICE

Measurement of the EVLWI

C-ARDS; Typical ARDS

Pulmonary Vascular Permeability Index DEVICE

Measurement of the PVPI

C-ARDS; Typical ARDS

Eligibility Criteria

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

Study Population

All patients with ARDS in the adult ICU that have a TPTD catheter inserted since 2018 will be eligible for recruitment

You may qualify if:

• ARDS defined by Berlin Criteria longer than 24 hours
• Undergoing mechanical ventilation
• Noradrenaline demand \>0.1 mcg/kg/min

You may not qualify if:

• Not meeting ARDS criteria
• Noninvasive mechanical ventilation
• ARDS resolved shorter than 24 hours
• Shock resolved

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpaşa

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• Monnet X, Teboul JL. Transpulmonary thermodilution: advantages and limits. Crit Care. 2017 Jun 19;21(1):147. doi: 10.1186/s13054-017-1739-5.

  PMID: 28625165 RESULT

MeSH Terms

Conditions

Respiratory Distress Syndrome; Pulmonary Edema; COVID-19; Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Injury

Study Officials

• Yalım Dikmen, Prof

  Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 8, 2020
• First Posted: August 11, 2020
• Study Start: September 1, 2020
• Primary Completion: September 30, 2020
• Study Completion: December 31, 2020
• Last Updated: October 26, 2021

Record last verified: 2021-10

Locations

TU (1)