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

Primary Purpose

Respiratory Distress Syndrome, Mechanical Ventilation, SARS (Severe Acute Respiratory Syndrome)

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
EIT-Group
ARDSNet
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Distress Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • USP Instituto do CoraçãoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

ARDSNet

EIT-Group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Average daily Modified Lung injury score until day 28
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

High oxygen dependence free days until day 28
Number of days with less than or equal to 1 Liter/min of oxygen supplementation until day 28
Mechanical ventilation free days until day 28
Number of days free of mechanical ventilation assistance after protocol inclusion and before day 28
Incidence of shock or barotrauma
Occurrence of shock (persistent hypotension despite rescue measures) and incidence of barotrauma
Incidence of acute renal failure requiring renal replacement therapy
Occurrence of acute renal failure that justifies renal replacement therapy
28-day mortality
Percentage of patients who died in each arm up to 28 days

Full Information

First Posted
July 31, 2020
Last Updated
May 5, 2022
Sponsor
University of Sao Paulo General Hospital
Collaborators
InCor Heart Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04497454
Brief Title
Mechanical Ventilation Strategy for Coronavirus Disease 2019 (COVID-19)
Acronym
COVEN
Official Title
Mechanical Ventilation Strategy for Coronavirus Disease 2019 (COVID-19) - COVEN Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 8, 2020 (Actual)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
InCor Heart Institute

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Mechanical ventilatory strategy of the ARDS Network low PEEP-FiO2 table will be followed 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, minimizing tidal lung strain by keeping driving pressure below 16 cmH2O throughout the mechanical ventilation period will be targeted. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome, Mechanical Ventilation, SARS (Severe Acute Respiratory Syndrome)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomized, single-center, open-label, superiority, controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ARDSNet
Arm Type
Active Comparator
Arm Description
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.
Arm Title
EIT-Group
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
EIT-Group
Intervention Description
A mechanical ventilation strategy with the main goal to maintain DP < 16 cmH2O
Intervention Type
Other
Intervention Name(s)
ARDSNet
Intervention Description
Low PEEP-FiO2 table ARDS Network ventilation protocol
Primary Outcome Measure Information:
Title
Average daily Modified Lung injury score until day 28
Description
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.
Time Frame
daily
Secondary Outcome Measure Information:
Title
High oxygen dependence free days until day 28
Description
Number of days with less than or equal to 1 Liter/min of oxygen supplementation until day 28
Time Frame
28 days
Title
Mechanical ventilation free days until day 28
Description
Number of days free of mechanical ventilation assistance after protocol inclusion and before day 28
Time Frame
28 days
Title
Incidence of shock or barotrauma
Description
Occurrence of shock (persistent hypotension despite rescue measures) and incidence of barotrauma
Time Frame
28 days
Title
Incidence of acute renal failure requiring renal replacement therapy
Description
Occurrence of acute renal failure that justifies renal replacement therapy
Time Frame
28 days
Title
28-day mortality
Description
Percentage of patients who died in each arm up to 28 days
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eduardo LV Costa, PhD
Phone
+551130617361
Email
eduardoleitecosta@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Maria AM Nakamura, PhD
Phone
+551130617151
Email
mamiyukinakamura@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduardo LV Costa, PhD
Organizational Affiliation
Hospital das Clinicas from University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
USP Instituto do Coração
City
São Paulo
ZIP/Postal Code
05.403-010
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eduardo LV Costa
Phone
+551130667361
Email
eduardoleitecosta@gmail.com
First Name & Middle Initial & Last Name & Degree
Maria AM Nakamura
Phone
+551130667151
Email
mamiyukinakamura@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35767435
Citation
Hohmann F, Wedekind L, Grundeis F, Dickel S, Frank J, Golinski M, Griesel M, Grimm C, Herchenhahn C, Kramer A, Metzendorf MI, Moerer O, Olbrich N, Thieme V, Vieler A, Fichtner F, Burns J, Laudi S. Early spontaneous breathing for acute respiratory distress syndrome in individuals with COVID-19. Cochrane Database Syst Rev. 2022 Jun 29;6(6):CD015077. doi: 10.1002/14651858.CD015077.
Results Reference
derived

Learn more about this trial

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

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