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COVID-19 PneumoniaNCT05019313

Diaphragm Ultrasound Evaluation During Weaning From Mechanical Ventilation in the Positive COVID-19 Patient

An observational study of COVID-19 Pneumonia and Diaphragm Disease, run by Azienda Sanitaria-Universitaria Integrata di Udine at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Hypoxemic acute respiratory failure is one of the main COVID-19 patients complication that lead to in intensive care hospitalization. This complication determines a variable mortality from 25 to 30%. To correct hypoxemia (often severe) is often needed non-invasive or invasive mechanical ventilation. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
COVID-19 Pneumonia, Diaphragm Disease
What is being tested?
Evaluation of diaphragmatic contractility by ultrasound
Type of treatment
Medical device
How many people
38 participants
Where
1 siteItaly
Study dates
1 Apr 2020to 31 Mar 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with severe hypoxemic covid-related respiratory failure admitted to intensive care unit in Udine and five other centers. These subjects required mechanical ventilation during hospitalization.

Who may be able to join

  • Hypoxemic respiratory failure in COVID-19 patients during intensive care unit hospitalization
  • Age> 18 years
  • Weaning by mechanical ventilation

Who cannot join

  • tracheostomy,
  • unstable clinical conditions;
  • agitation (Richmond Agitation-Sedation Scale (RASS)≥ + 2) or non-cooperation (Kelly Matthay scale ≥5);
  • more than two organ failure
  • consent refusal

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD

    Udine, 33100

Other trials in Italy

About this study

Hypoxemic acute respiratory failure is one of the main COVID-19 patients complication that lead to in intensive care hospitalization.

This complication determines a variable mortality from 25 to 30%. To correct hypoxemia (often severe) is often needed non-invasive or invasive mechanical ventilation.

Read more

Mechanical ventilation is not a therapeutic strategy, but it allows to extend the time-to-recovery necessary to solve COVID-19 respiratory failure cause.

Calibration of ventilatory support is essential to ensure adequate time-to-recovery without contributing to onset lung and / or diaphragmatic damage.

Basal diaphragmatic activity assessment, device for administering the oxygenation support choice and setting ventilatory support parameters are decisive.

Ultrasound is the best method for measuring diaphragmatic work. The aim of this study is to evaluate the diaphragmatic thickening fraction in COVID-19 patients admitted to Intensive Care Unit (ICU) for acute respiratory failure and to record its function on weaning.

Read the detailed description

Hypoxemic acute respiratory failure in COVID-19 patients often leads to necessity of intubation and mechanical ventilation support. Complications may be severe as Ventilator-Induced Lung Injury (VILI) and respiratory infections. Weaning process from mechanical ventilation is based on respiratory work reduction and mechanical support to allow patient's respiratory ability to recovery. Respiratory muscle strength give an important contribute. Ultrasound diaphragmatic evaluation is essential to evaluate patients respiratory capacity as diaphragm atrophy usually suggest a difficult process and weaning failure.

COVID-19 pneumonia represent a particular type of ARDS (acute respiratory distress syndrome), in which different mechanism such as interstitial edema and diffuse alveolar damage, ventilation-perfusion mismatch, intrapulmonary shunt play a role/attend The aim of this study is to assess diaphragmatic function in weaning from mechanical ventilation in patients affected from COVID-19 respiratory failure and his implications.

Being tested
Evaluation of diaphragmatic contractility by ultrasound
Keywords
diaphragm thickening fraction, happy hypoxemia, diaphragmatic ultrasound evaluation, SARS-CoV-2 pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Evaluation of diaphragmatic contractility by ultrasoundDevice

    Lung ultrasound is performed during mechanical ventilation weaning. The diaphragmatic thickening fraction is evaluated positioning a linear probe in midaxillary line. Inspiratory and expiratory measurements are bilateral and are M-mode images. Right diaphragmatic thickening fraction has been considered as true and reproducible measurement.

Study groups in NCT05019313
Study groupRoleWhat they receive
COVID 19 positive patientsCOVID19 positive patients with hypoxemic acute respiratory failure hospitalized in intensive care unit. This study evaluates diaphragmatic contractility with ultrasound, blood gas analytical parameters during weaning from invasive mechanical ventilation
Receives: Device: Evaluation of diaphragmatic contractility by ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diaphragmatic function evaluation by measuring right diaphragmatic thickening fraction

    Right diaphragmatic thickening fraction is evaluated by positioning a linear ultrasound probe at the level of the midaxillary line (pointer oriented towards the axillary cavity). Patient is in the supine position. Inspiratory and expiratory measurements are made as M-mode images. Right diaphragmatic measurement is considered as a reference. .

    Measured: During weaning by mechanical ventilation before attempt of extubation

Secondary outcomes (1)

  1. Weaning attempt success/failure frequency with consequent need of tracheostomy or endotracheal re-intubation.

    After extubation it is considered as weaning attempt success a 48 hours time free need of non invasive (not prophylatic) or invasive ventilation with re-intubation and/or tracheostomy

    Measured: After weaning and eventually extubation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2021
  2. Study start1 Apr 2020
  3. Primary completion30 Jun 2021
  4. Study completion31 Mar 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05019313
Sponsor's protocol ID
COVID-DIAUS 1.2
Status last verified
Aug 2021
First submitted
2 Aug 2021
Last updated
24 Aug 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Grasselli G, Zangrillo A, Zanella A, Antonelli M, Cabrini L, Castelli A, Cereda D, Coluccello A, Foti G, Fumagalli R, Iotti G, Latronico N, Lorini L, Merler S, Natalini G, Piatti A, Ranieri MV, Scandroglio AM, Storti E, Cecconi M, Pesenti A; COVID-19 Lombardy ICU Network. Baseline Characteristics and Outcomes of 1591 Patients Infected With SARS-CoV-2 Admitted to ICUs of the Lombardy Region, Italy. JAMA. 2020 Apr 28;323(16):1574-1581. doi: 10.1001/jama.2020.5394.

    PubMed 32250385

  • Azoulay E, Thiery G, Chevret S, Moreau D, Darmon M, Bergeron A, Yang K, Meignin V, Ciroldi M, Le Gall JR, Tazi A, Schlemmer B. The prognosis of acute respiratory failure in critically ill cancer patients. Medicine (Baltimore). 2004 Nov;83(6):360-370. doi: 10.1097/01.md.0000145370.63676.fb.

    PubMed 15525848

  • Thiery G, Azoulay E, Darmon M, Ciroldi M, De Miranda S, Levy V, Fieux F, Moreau D, Le Gall JR, Schlemmer B. Outcome of cancer patients considered for intensive care unit admission: a hospital-wide prospective study. J Clin Oncol. 2005 Jul 1;23(19):4406-13. doi: 10.1200/JCO.2005.01.487.

    PubMed 15994150

  • Gattinoni L, Chiumello D, Caironi P, Busana M, Romitti F, Brazzi L, Camporota L. COVID-19 pneumonia: different respiratory treatments for different phenotypes? Intensive Care Med. 2020 Jun;46(6):1099-1102. doi: 10.1007/s00134-020-06033-2. Epub 2020 Apr 14. No abstract available.

    PubMed 32291463

  • Vetrugno L, Bove T, Orso D, Barbariol F, Bassi F, Boero E, Ferrari G, Kong R. Our Italian experience using lung ultrasound for identification, grading and serial follow-up of severity of lung involvement for management of patients with COVID-19. Echocardiography. 2020 Apr;37(4):625-627. doi: 10.1111/echo.14664. Epub 2020 Apr 15.

    PubMed 32239532

  • Vetrugno L, Orso D, Corradi F, Zani G, Spadaro S, Meroi F, D'Andrea N, Bove T, Cammarota G, De Robertis E, Ferrari S, Guarnieri M, Ajuti M, Fusari M, Grieco DL, Deana C, Boero E, Franchi F, Scolletta S, Maggiore SM, Forfori F. Diaphragm ultrasound evaluation during weaning from mechanical ventilation in COVID-19 patients: a pragmatic, cross-section, multicenter study. Respir Res. 2022 Aug 21;23(1):210. doi: 10.1186/s12931-022-02138-y.

    PubMed 35989352

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19 Pneumonia and Diaphragm Disease, run by Azienda Sanitaria-Universitaria Integrata di Udine at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diaphragmatic function evaluation by measuring right diaphragmatic thickening fraction (time frame: During weaning by mechanical ventilation before attempt of extubation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05019313, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2021.

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