Respiratory Failure Clinical Trial
Official title:
Acute Respiratory Failure and Continuous Positive Airway Pressure Therapy in Patients With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection: a Real Life Evaluation
In December 2019 a new kind of virus was identified in China as the responsible of severe
acute respiratory syndrome (SARS) and interstitial pneumonia. Severe acute respiratory
syndrome coronavirus 2 (SARS-CoV-2) quickly spread around the world and in February 2020
became a pandemia in Europe.
No pharmacological treatment is actually licensed for the SARS-CoV2 infection and at the
current state of art there is a lack of data about the clinical management of the coronavirus
2019 disease (COVID-19).
The aim of this observational study is to collect the data and the outcomes of COVID-19
patients admitted in the H. Sacco Respiratory Unit treated according to the Standard
Operating Procedures and the Good Clinical Practice.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 31, 2020 |
Est. primary completion date | September 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients that can give written or oral informed consent - patients with microbiological diagnosis (i.e. rhinopharyngeal swab) of SARS-CoV2 infection Exclusion Criteria: - severe cognitive impairment - absolute contraindication to non invasive ventilation or cpap therapy - rhinopharyngeal swab negative for SARS-CoV2 |
Country | Name | City | State |
---|---|---|---|
Italy | Luigi Sacco University Hospital | Milan | Lombardia |
Lead Sponsor | Collaborator |
---|---|
University of Milan |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Real life data of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection | Data collection about the real life management of patients affected by SARS-CoV-2 infection with acute respiratory distress syndrome | 1-6 months | |
Secondary | in-hospital mortality | How many patients died during the hospitalization | 1 month | |
Secondary | 30 days mortality | How many patients died 30 days after the discharge | 1 month | |
Secondary | 6 months mortality | How many patients died 6 months after the discharge | 6 months | |
Secondary | Intubation rate | How many patients were intubated during the hospitalization | 7 days | |
Secondary | Time to Intubation | How many days/hours from admittance to intubation | 7 days | |
Secondary | Time to ventilation | How many days/hours from admittance to the start of non invasive ventilation or CPAP therapy | 7 days | |
Secondary | Non invasive to Invasive time | How many days/hours from the start of non invasive ventilation or CPAP therapy to the intubation | 7 days | |
Secondary | Recovery rate | How many patients were healed from the infection and discharged | 1 month | |
Secondary | Recurrence rate | How many patients underwent re-infection after previous recovery from COVID19 | 1 month | |
Secondary | Risk factor for COVID19 | Assessment of the risk factors for the infection and the admission to the hospital | retrospective | |
Secondary | Blood tests and outcome | What serological parameter could be used as predictor of good or negative prognosis. | 1 month | |
Secondary | Antiviral therapy | Impact of antiviral therapy on the clinical course of the disease | 1 month | |
Secondary | Coinfections | Assessment of bacterial, fungal or other coinfections rate | 1 month | |
Secondary | Radiological findings | Impact of radiological findings on the clinical course and the outcome | 1 month | |
Secondary | Ultrasound findings | Impact of ultrasound findings on the clinical course and the outcome | 1 month | |
Secondary | Myocardial injury | Assessment of the evidence of myocardial injury in covid19+ patients | 1 month | |
Secondary | Medical management | impact of standard therapeutic operating procedures (eg enteral nutrition, hydration, drugs) on the clinical course. | 1 month |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03909854 -
Pragmatic Investigation of Volume Targeted Ventilation-1
|
N/A | |
Recruiting |
NCT03662438 -
HOPE (Home-based Oxygen [Portable] and Exercise) for Patients on Long Term Oxygen Therapy (LTOT)
|
N/A | |
Recruiting |
NCT05308719 -
Nasal Oxygen Therapy After Cardiac Surgery
|
N/A | |
Recruiting |
NCT05535543 -
Change in the Phase III Slope of the Volumetric Capnography by Prone Positioning in Acute Respiratory Distress Syndrome
|
||
Completed |
NCT04030208 -
Evaluating Safety and Efficacy of Umbulizer in Patients Requiring Intermittent Positive Pressure Ventilation
|
N/A | |
Recruiting |
NCT04668313 -
COVID-19 Advanced Respiratory Physiology (CARP) Study
|
||
Recruiting |
NCT04542096 -
Real Time Evaluation of Dynamic Changes of the Lungs During Respiratory Support of VLBW Neonates Using EIT
|
||
Recruiting |
NCT05883137 -
High-flow Nasal Oxygenation for Apnoeic Oxygenation During Intubation of the Critically Ill
|
||
Completed |
NCT04505592 -
Tenecteplase in Patients With COVID-19
|
Phase 2 | |
Completed |
NCT03943914 -
Early Non-invasive Ventilation and High-flow Nasal Oxygen Therapy for Preventing Delayed Respiratory Failure in Hypoxemic Blunt Chest Trauma Patients.
|
N/A | |
Active, not recruiting |
NCT03472768 -
The Impact of Age-dependent Haptoglobin Deficiency on Plasma Free Hemoglobin Levels During Extracorporeal Membrane Oxygenation Support
|
||
Not yet recruiting |
NCT04538469 -
Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff
|
||
Not yet recruiting |
NCT02542423 -
Endocan Predictive Value in Postcardiac Surgery Acute Respiratory Failure.
|
N/A | |
Completed |
NCT02265198 -
Relationship of Pulmonary Contusion to Pulmonary Inflammation and Incidence of Acute Respiratory Distress Syndrome
|
N/A | |
Completed |
NCT01885442 -
TryCYCLE: A Pilot Study of Early In-bed Leg Cycle Ergometry in Mechanically Ventilated Patients
|
N/A | |
Completed |
NCT02105298 -
Effect of Volume and Type of Fluid on Postoperative Incidence of Respiratory Complications and Outcome (CRC-Study)
|
N/A | |
Completed |
NCT01659268 -
Performance of Baccalaureate Nursing Students in Insertion of Laryngeal Mask: a Trial in Mannequins
|
N/A | |
Completed |
NCT02814994 -
Respiratory System Compliance Guided VT in Moderate to Severe ARDS Patients
|
N/A | |
Completed |
NCT01204281 -
Proportional Assist Ventilation (PAV) in Early Stage of Critically Ill Patients
|
Phase 4 | |
Completed |
NCT01249794 -
Non Invasive Ventilation After Cardiac Surgery
|
N/A |