Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Mechanical Ventilation Strategy for Coronavirus Disease 2019 (COVID-19) (COVEN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04497454
Recruitment Status : Recruiting
First Posted : August 4, 2020
Last Update Posted : August 4, 2020
Sponsor:
Collaborator:
InCor Heart Institute
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

Brief Summary:
This is a prospective, randomized, single-center, open-label controlled trial, designed to compare the efficacy of two ventilation strategies (Low Tidal Volume and positive end-expiratory pressure (PEEP) based on the Acute Respiratory Distress Syndrome (ARDS) Network low PEEP-fraction of inspired oxygen inspired oxygen fraction (FIO2) Table versus Low Driving Pressure and PEEP guided by Electrical Impedance Tomography (EIT) in reducing daily lung injury score in patients with acute respiratory distress syndrome caused by COVID-19. The two strategies incorporate different prioritizations of clinical variables. The PEEP-FIO2 table strategy aims to reduce lung overdistension, even if it requires tolerating worse gas exchange. EIT-guided strategy prioritizes mechanical stress protection, avoiding alveolar overdistension and collapse.

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome Severe Acute Respiratory Syndrome Due to Coronavirus (SARS-CoV2) Mechanical Ventilation Other: EIT-Group Other: ARDSNet Not Applicable

Detailed Description:
We will follow the ventilator strategy of the ARDS Network low PEEP-FiO2 table in the control arm. This strategy consists of at least 12 hours of controlled mechanical ventilation following prespecified PEEP and FiO2 combinations chosen dynamically targeting oxygenation. Tidal volume is set at 4-6 mL/Kg of predicted body weight (PBW) and plateau pressure is kept below 30 centimeters of water (cmH2O). Respiratory rate can be as high as 35 breaths per minute titrated to a potential of hydrogen (pH) 7.30-7.45. As oxygenation improves, patients are transitioned to assisted ventilation and then to pressure support ventilation until they are ready to be liberated from the ventilator. During this phase, no attempt is made to control plateau pressures or tidal volumes. In the intervention arm, we will focus on minimizing tidal lung strain by keeping driving pressure below 16 cmH2O throughout the mechanical ventilation period. The controlled phase will last at least 48 hours. PEEP will be selected according to a PEEP titration maneuver with EIT at the start of the intervention. This PEEP level will be kept until extubation. Respiratory rate can be as high as 50 breaths per minute targeting a pH of 7.15-7.45.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, randomized, single-center, open-label, superiority, controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mechanical Ventilation Strategy for Coronavirus Disease 2019 (COVID-19) - COVEN Study
Actual Study Start Date : May 8, 2020
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : December 1, 2021


Arm Intervention/treatment
Active Comparator: ARDSNet
ARDSNet protocol (low PEEP-FiO2 table). Ventilatory mode: volume-controlled ventilation Tidal volume (VT) will be adjusted to 4-6 mL/Kg of PBW and Plateau pressure < 30 cmH2O for the at least the first 12 hours after inclusion in the protocol pH should be maintained between 7.35-7.45 Oxygenation (SpO2) target ranges 90-95% Maximum respiratory rate = 35 breaths/min PEEP and FIO2 adjusted according to the low PEEP-FiO2 Table.
Other: ARDSNet
Low PEEP-FiO2 table ARDS Network ventilation protocol

Experimental: EIT-Group
The goal is to maintain driving pressure (DP) < 16 cmH2O. Ventilatory mode: pressure-controlled ventilation After a recruitment a maneuver, PEEP will be chosen according to a PEEP titration maneuver monitored with electrical impedance tomography Plateau pressure may exceed 30 cmH2O and VT may exceed 6 mL/Kg if DP < 16 cmH2O pH should be maintained between 7.15-7.40 Oxygenation (SpO2) target ranges 90 -95% Maximum respiratory rate = 50 bpm
Other: EIT-Group
A mechanical ventilation strategy with the main goal to maintain DP < 16 cmH2O




Primary Outcome Measures :
  1. Average daily Modified Lung injury score until day 28 [ Time Frame: daily ]
    This score originally ranges from 0 to 4 points based on the average of 4 parameters (PaO2/FiO2, chest X-Ray, PEEP level, and Respiratory compliance). In the modified version, if the patient dies, he or she automatically receives a score of 5 irrespective of the other four parameters. If the patient is extubated, the score is automatically zero. We also substituted FiO2 for PEEP guaranteeing equivalence of the score when either the low or high PEEP-FiO2 table is applied.


Secondary Outcome Measures :
  1. High oxygen dependence free days until day 28 [ Time Frame: 28 days ]
    Number of days with less than or equal to 1 Liter/min of oxygen supplementation until day 28

  2. Mechanical ventilation free days until day 28 [ Time Frame: 28 days ]
    Number of days free of mechanical ventilation assistance after protocol inclusion and before day 28

  3. Incidence of shock or barotrauma [ Time Frame: 28 days ]
    Occurrence of shock (persistent hypotension despite rescue measures) and incidence of barotrauma

  4. Incidence of acute renal failure requiring renal replacement therapy [ Time Frame: 28 days ]
    Occurrence of acute renal failure that justifies renal replacement therapy

  5. 28-day mortality [ Time Frame: 28 days ]
    Percentage of patients who died in each arm up to 28 days



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients under mechanical ventilation with ARDS (Berlin definition) caused by SARS-COV2 infection:

  • ARDS diagnosis in less than 24 hours
  • Respiratory System Compliance of 0.6 mL/cmH2O/Kg of PBW

Exclusion Criteria:

  • Age < 18 years
  • Active bronchopleural fistula
  • History of chronic and disabling respirator disease, requiring home oxygen treatment
  • Chronic pulmonary arterial hypertension (pulmonary artery systolic pressure > 40 mmHg)
  • Huge intrathoracic tumoral mass
  • Electrical impedance tomography monitoring contraindications (as thoracic wounds or burns, electronic implantable devices)
  • Hemodynamic instability (systolic pressure < 80 mmHg or mean arterial pressure < 60 mmHg, despite vasopressor drugs; and/or heart rate < 55bpm) - this patient may be included after recovered from hemodynamic instability
  • Not drained pneumothorax or subcutaneous emphysema or bronchopleural fistula
  • Patients at risk of intracranial hypertension development or post Cardiopulmonary resuscitation (first 72 hours)
  • Pregnancy
  • Impossibility of monitoring with EIT
  • Not committed to full support or life expectation < 24 hours
  • Legal responsible or clinical team refusal to participate in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04497454


Contacts
Layout table for location contacts
Contact: Eduardo LV Costa, PhD +551130617361 eduardoleitecosta@gmail.com
Contact: Maria AM Nakamura, PhD +551130617151 mamiyukinakamura@gmail.com

Locations
Layout table for location information
Brazil
USP Instituto do Coração Recruiting
São Paulo, Brazil, 05.403-010
Contact: Eduardo LV Costa    +551130667361    eduardoleitecosta@gmail.com   
Contact: Maria AM Nakamura    +551130667151    mamiyukinakamura@gmail.com   
Sponsors and Collaborators
University of Sao Paulo General Hospital
InCor Heart Institute
Layout table for additonal information
Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT04497454    
Other Study ID Numbers: CAAE: 30938720800000068
First Posted: August 4, 2020    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronavirus Infections
Severe Acute Respiratory Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections