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

Mechanical Ventilation Clinical Trial

— COVEN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04497454
• Other study ID #: CAAE: 30938720800000068
• Status: Recruiting
• Phase: N/A
• Start date: May 8, 2020
• Est. completion date: December 1, 2022

Study information

• Verified date: May 2022
• Source: University of Sao Paulo General Hospital
• Contact: Eduardo LV Costa, PhD
• Phone: +551130617361
• Email: eduardoleitecosta[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: December 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Mechanical Ventilation
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• SARS (Severe Acute Respiratory Syndrome)
• Severe Acute Respiratory Syndrome
• Syndrome

Intervention

Other:
• EIT-Group
A mechanical ventilation strategy with the main goal to maintain DP < 16 cmH2O
• ARDSNet
Low PEEP-FiO2 table ARDS Network ventilation protocol

Locations

Country	Name	City	State
Brazil	USP Instituto do Coração	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	InCor Heart Institute

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	daily
Secondary	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	28 days
Secondary	Mechanical ventilation free days until day 28	Number of days free of mechanical ventilation assistance after protocol inclusion and before day 28	28 days
Secondary	Incidence of shock or barotrauma	Occurrence of shock (persistent hypotension despite rescue measures) and incidence of barotrauma	28 days
Secondary	Incidence of acute renal failure requiring renal replacement therapy	Occurrence of acute renal failure that justifies renal replacement therapy	28 days
Secondary	28-day mortality	Percentage of patients who died in each arm up to 28 days	28 days