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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-08

Study Completion Date

2022-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical and Functional Outcomes of Critically Ill Patients With COVID-19

NCT05024500

Acute Respiratory Distress Syndrome (ARDS)

COMPLETED NA

Respiratory Mechanics and Gas Exchange Characteristics in Patient With SARS-CoV-2

NCT04486729

Covid19 ARDS, Human

UNKNOWN

Comparison of 2 Ventilatory Support Strategies During Coronavirus Disease 2019 (Covid-19) Pneumonia

NCT04799691

COVID-19

COMPLETED

Risk Factors for Prolonged Invasive Mechanical Ventilation in COVID-19 Acute Respiratory Distress Syndrome

NCT04411459

COVID-19 Mechanical Ventilation Quality of Life +3 more

COMPLETED

Clinical Characteristics and Outcomes of Patients With COVID-19 on Mechanical Ventilation in Argentina

NCT04611269

Respiratory Failure Covid-19 Mechanical Ventilation

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, randomized, single-center, open-label, superiority, controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

ARDSNet

Intervention Type OTHER

Low PEEP-FiO2 table ARDS Network ventilation protocol

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

Group Type EXPERIMENTAL

EIT-Group

Intervention Type OTHER

A mechanical ventilation strategy with the main goal to maintain DP \< 16 cmH2O

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

EIT-Group

A mechanical ventilation strategy with the main goal to maintain DP \< 16 cmH2O

Intervention Type OTHER

ARDSNet

Low PEEP-FiO2 table ARDS Network ventilation protocol

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No