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HEMOCOVID19: Non-invasive Characterization of Systemic Microvascular Reactivity by Near-infrared Diffuse Optical Spectroscopy in COVID-19 Patients

Sponsor
Corporacion Parc Tauli (Other)
Overall Status
Recruiting
CT.gov ID
NCT04689477
Collaborator
Institut de Ciències Fotòniques (ICFO) (Other), Centre de Recerca Matemàtica (Other), Institute of Physics University of Campinas (Other)
612
Enrollment
8
Locations
28.2
Anticipated Duration (Months)
76.5
Patients Per Site
2.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to characterize microvascular reactivity on the forearm muscle using non-invasive near-infrared spectroscopy in critically ill COVID-19 patients, and to correlate its alterations with 28-day mortality in ICU COVID-19 patients.

Condition or Disease Intervention/Treatment Phase
  • Device: Vascular occlusion test

Detailed Description

After giving consent to participate in the study, the subjects included in the study will undergo a 15-minute measurement of tissue oxygen saturation (StO2) measured non-invasively on the forearm by means of near-infrared spectroscopy (NIRS). Once a baseline stable StO2 value is obtained, a provocative test, consisting of a transient vascular occlusion, will be performed. The test will allow the obtention of a local metabolic rate, and a StO2 recovery rate after the ischemic stimulus. This StO2 recovery rate will be considered as a reflection of the endothelial health of the patient.

Patients will be studied as soon as possible after admission to the ICU, and followed-up until ICU discharge or death.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
612 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Non-invasive Characterization of Systemic Microvascular Reactivity by Near-infrared Diffuse Optical Spectroscopy in COVID-19 Patients
Actual Study Start Date :
May 25, 2020
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
COVID-19

Hospitalized patients diagnosed with COVID-19, presenting with arterial hypoxemia.

Device: Vascular occlusion test
The ischemic challenge will consist in a standardized Vascular Occlusion Test (VOT), as previously described in the literature. Briefly, a blood pressure cuff will be placed proximal to the forearm, and rapidly inflated at 40 mmHg above systolic pressure, and kept inflated during three minutes. Then the cuff will be rapidly deflated. The resulting deoxygenation (DeO2) and reoxygenation (ReO2) slopes will be reported as change in O2 saturation over time.
Control

Healthy subjects

Device: Vascular occlusion test
The ischemic challenge will consist in a standardized Vascular Occlusion Test (VOT), as previously described in the literature. Briefly, a blood pressure cuff will be placed proximal to the forearm, and rapidly inflated at 40 mmHg above systolic pressure, and kept inflated during three minutes. Then the cuff will be rapidly deflated. The resulting deoxygenation (DeO2) and reoxygenation (ReO2) slopes will be reported as change in O2 saturation over time.
Non-COVID critically ill patients

Non-COVID critically ill patients admitted to the ICU.

Device: Vascular occlusion test
The ischemic challenge will consist in a standardized Vascular Occlusion Test (VOT), as previously described in the literature. Briefly, a blood pressure cuff will be placed proximal to the forearm, and rapidly inflated at 40 mmHg above systolic pressure, and kept inflated during three minutes. Then the cuff will be rapidly deflated. The resulting deoxygenation (DeO2) and reoxygenation (ReO2) slopes will be reported as change in O2 saturation over time.

Outcome Measures

Primary Outcome Measures

  1. 28-day mortality [28 days]

    Mortality at 28 days of patients admitted to the ICU as results of respiratory failure secondary to COVID-19

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Recent diagnosis of SARS-CoV2 infection

  • Arterial hypoxemia and bilateral alveolar infiltrates, not explained by cardiac dysfunction or fluid overload.

Exclusion Criteria:

  • Severe peripheral vasculopathy

  • Raynaud's syndrome

  • Skin lesions or trauma in upper limbs interfering the placement of NIRS probe and/or the occlusion tourniquet

  • Deep venous thrombosis in the upper limbs

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Texas Southwestern Medical Center Dallas Texas United States 75390
2 Hospital de Clinicas da UNICAMP Campinas Sao Paulo Brazil
3 Hospital Das Clínicas University of Sao Paulo Medical School Sao Paulo Brazil
4 Hospital General de México México Mexico
5 Institut d'Investigació i Innovació Parc Taulí Sabadell Barcelona Spain 08208
6 Hospital Clínic i Provincial de Barcelona Barcelona Spain
7 Hospital Parc Salut Mar Barcelona Spain
8 Hospital Vall d'Hebron Barcelona Spain

Sponsors and Collaborators

  • Corporacion Parc Tauli
  • Institut de Ciències Fotòniques (ICFO)
  • Centre de Recerca Matemàtica
  • Institute of Physics University of Campinas

Investigators

  • Principal Investigator: Jaume Mesquida, MD, PhD, Corporacion Parc Tauli

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Jaume Mesquida, MD, PhD, Corporacion Parc Tauli
ClinicalTrials.gov Identifier:
NCT04689477
Other Study ID Numbers:
  • 2020/579
First Posted:
Dec 30, 2020
Last Update Posted:
Aug 1, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Jaume Mesquida, MD, PhD, Corporacion Parc Tauli
COVID-19
Additional relevant MeSH terms:
COVID-19

Study Results

No Results Posted as of Aug 1, 2022