NCT04497454

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 8, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 4, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

May 11, 2022

Status Verified

May 1, 2022

Enrollment Period

2.1 years

First QC Date

July 31, 2020

Last Update Submit

May 5, 2022

Conditions

Respiratory Distress SyndromeMechanical VentilationSARS (Severe Acute Respiratory Syndrome)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • High oxygen dependence free days until day 28

    28 days

  • Mechanical ventilation free days until day 28

    28 days

  • Incidence of shock or barotrauma

    28 days

  • Incidence of acute renal failure requiring renal replacement therapy

    28 days

  • 28-day mortality

    28 days

Study Arms (2)

ARDSNet

ACTIVE COMPARATOR

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

EIT-Group

EXPERIMENTAL

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

Interventions

EIT-GroupOTHER

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

EIT-Group
ARDSNetOTHER

Low PEEP-FiO2 table ARDS Network ventilation protocol

ARDSNet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USP Instituto do Coração

São Paulo, 05.403-010, Brazil

RECRUITING

Related Publications (2)

  • Costa ELV, Alcala GC, Tucci MR, Goligher E, Morais CC, Dianti J, Nakamura MAP, Oliveira LB, Pereira SM, Toufen C Jr, Barbas CSV, Carvalho CRR, Amato MBP. Impact of extended lung protection during mechanical ventilation on lung recovery in patients with COVID-19 ARDS: a phase II randomized controlled trial. Ann Intensive Care. 2024 Jun 8;14(1):85. doi: 10.1186/s13613-024-01297-z.

    PMID: 38849605DERIVED

  • 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.

    PMID: 35767435DERIVED

MeSH Terms

Conditions

Respiratory Distress SyndromeSevere Acute Respiratory Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersRespiratory Tract InfectionsInfectionsCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus Diseases

Study Officials

  • Eduardo LV Costa, PhD

    Hospital das Clinicas from University of São Paulo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eduardo LV Costa, PhD

CONTACT

+551130617361eduardoleitecosta@gmail.com

Maria AM Nakamura, PhD

CONTACT

+551130617151mamiyukinakamura@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective, randomized, single-center, open-label, superiority, controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2020

First Posted

August 4, 2020

Study Start

May 8, 2020

Primary Completion

July 1, 2022

Study Completion

December 1, 2022

Last Updated

May 11, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)