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Completed

NCT Number: NCT04815304

Clinical Features of COVID-19 Patients

The data were retrospectively collected during the first and the second wave of epidemic in COVID-19 patients with Severe Acute Respiratory Syndrome Coronavirus 2, at the moment of intensive care unit admission and during the in intensive care unit staying.

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Key information

Conditions

Covid19 Acute Respiratory Distress Syndrome COVID-19 Coronaviridae Infections Coronavirus Infections Hypoventilation Infections Lung Diseases Nidovirales Infections Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiration Disorders Respiratory Distress Syndrome Respiratory Insufficiency Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Respiratory Ventilatory Failure Virus Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

San Salvatore Academic Hospital

L’Aquila, 67100, Italy

About this study

At the moment of intensive care unit admission and during the in intensive care unit staying, the following data were collected: peripheral lymphocyte subsets were measured by multiple-color flow cytometry, chest computed tomography and ultrasonography scans, arterial blood gas parameters (pH, partial pressure of carbon dioxide, partial pressure of oxygen, concentration of hydrogen carbonate, base excess, and arterial oxygen saturation), and pain assessed by using numeric rating scale.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • COVID-19 patients
  • Acute respiratory distress syndrome
  • needing of ventilatory support

Exclusion criteria

  • asymptomatic COVID-19 patients
  • few symptoms
  • mild symptoms
  • without needing of ventilatory support

Treatment and study plan

peripheral lymphocytes subsets

Diagnostic Test

The data were collected during the first and the second wave of epidemic in COVID-19 patients with acute respiratory distress syndrome. At the moment of hospitalization, at the moment of intensive care unit admission and during the in intensive care unit staying, the following data were collected: peripheral lymphocyte subsets were measured by multiple-color flow cytometry, chest computed tomography and ultrasonography scans (lung ultrasound score, diaphragmatic thickness and motion), arterial blood gas analysis parameters (pH, partial pressure of carbon dioxide, partial pressure of oxygen, concentration of hydrogen carbonate, base excess, and arterial oxygen saturation ), and pain assessed by using numeric rating scale. Macroscopic and microscopic hypopharynx and larynx damages were also evaluated by video-laryngoscopy and light miscoscopy.

Other names: Chest computed tomography, Chest ultrasonography scan, arterial blood gas analysis, pain

Primary outcomes

  1. Peripheral lymphocyte subsets

    Time frame: Change from date of hospitalization until the date of hospital discharge or date of death from any cause, whichever came first, assessed at 60 weeks

    Peripheral lymphocyte subsets were measured by multiple-color flow cytometry,

Secondary outcomes

  1. Chest computed tomography

    Time frame: From date of hospitalization until the date of hospital discharge or date of death from any cause, whichever came first, assessed every 10 days up to 60 weeks

    A chest computed tomography performed to assess lung damage

  2. Chest ultrasonography

    Time frame: From date of hospitalization until the date of hospital discharge or date of death from any cause, whichever came first, assessed every day up to 60 weeks

    Lung ultrasound score (sum of points in all 12 regions and ranges from 0 to 36; 0 points-presence of lung sliding with A lines or one or two isolated B lines; 1 point-moderate loss of lung aeration with three or four B lines (septal rockets); 2 points-severe loss of lung aeration with five or more B lines (glass rockets); and 3 points-presence of a hypoechoic poorly defined tissue characterized by consolidation)

  3. Pain assessment

    Time frame: From date of hospitalization until the date of hospital discharge or date of death from any cause, whichever came first, assessed every day up to 60 weeks

    Pain assessed by using numeric rating scale (the 11-point numeric scale ranges from '0' representing one pain extreme [e.g. "no pain"] to '10' representing the other pain extreme [e.g. "pain as bad as you can imagine" or "worst pain imaginable])

  4. Upper airway damages

    Time frame: From date of hospitalization until the date of hospital discharge or date of death from any cause, whichever came first, assessed every day up to 60 weeks

    Macroscopic and microscopic hypopharynx and larynx damages evaluated by video-laryngoscopy and light microscopy

Sponsors and collaborators

Lead sponsor

San Salvatore Hospital of L'Aquila

Other

Registry information

Official study title

Clinical Features of Severe Acute Respiratory Syndrome Coronavirus 2 Patients Admitted to the Intensive Care Units of Academic Hospital of L'Aquila (Italy)

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 25, 2021
Registry last updated
Nov 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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