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NCT Number: NCT05024500

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

People affected by Severe Acute Respiratory Syndrome (SARS) by COVID-19 virus my require a long lasting invasive mechanical ventilation life support. To prevent damages to the lungs a number of protective lung ventilation measures are taken, one of them encounters the positive end expiratory pressure (PEEP) titration. Up to date, it is unclear the best method to titrate PEEP considering this unconventional syndrome compared to other etiologies. In addition to the long lasting advanced life support and bedridden condition, other factors may affect respiratory and peripheral muscle function of these patients. Therefore, the investigators intend to follow up these patients randomized to one of the three-arm experimental PEEP titration and after ICU discharge their status on clinical, laboratory and physical functions assessments.

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Key information

Conditions

Acute Respiratory Distress Syndrome (ARDS) Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Geral Otavio de Freitas, Recife, Pernambuco, Brazil

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About this study

Introduction: Coronavirus Disease 2019 (COVID-19), caused by Severe Acute Respiratory Syndrome - Coronavirus-2 (SARS-CoV-2) requires mechanical ventilatory (MV) life support. In this scenario, lung protective strategies have been recommended for avoiding ventilator induced lung injuries mainly by inappropriate positive end expiratory pressure (PEEP) titration. However, the best method of PEEP titration for these patients remains unclear, since its clinical and morphofunctional phenotype may differ from the conventional acute respiratory distress syndrome (ARDS) phenotype resulted from other etiologies. In addition, these patients' condition of long lasting MV dependency and bed restriction may lead to deterioration of respiratory and peripheral muscles functions.

Objective: To compare the clinical and laboratory evolution and the respiratory and peripheral muscle functions in mechanically ventilated patients with COVID-19 submitted to PEEP titration by the following methods: ARDSNet protocol, driving pressure (DP) and electrical impedance tomography (EIT), as well as following them up after hospital discharge.

Methods: This is a controlled, randomized, double blind clinical trial with 90 mechanically ventilated patients to be randomized in one of the 3 PEEP titration- related groups: ARDSNet protocol, Driving Pressure-DP (electing PEEP level by the lowest DP) and by the EIT (PEEP selected will be the closest level above the intercept point of cumulated collapse and overdistension percentage curves). Clinical, laboratory, oxygenation, ventilation, respiratory and regional mechanics data, as well as peripheral muscle outcomes (strength and functionality) will be monitored from intubation to extubation in the supine and prone position. The outcomes of respiratory and peripheral muscles functionality will be monitored for six months after hospital discharge. All ethical principles will be respected with either written Free and Consent Term by the patient or relatives at the intensive care phase or at the post ICU discharge phase. Data will be registered for posterior analysis, which considers the difference between groups with p <0.05.

Expected results: Based on this study, it is expected to identify the Peep titration method associated to the greater beneficial and less deleterious effects in critically ill patients on MV. Also to address appropriate lung protective ventilation strategy for these patients and to detect respiratory and peripheral muscle disorders as early as possible in critically ill survivors.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • mechanically ventilated patients due to acute respiratory failure associated to COVID-19 confirmed or suspected cases

Exclusion criteria

  • consent refusal by patient, family or doctor

Treatment and study plan

ARDSNet table

Other

The setting of the lowest PEEP level and FiO2 match stated by the table to achieve a goal oxygenation.

Driving Pressure

Other

The setting of the lowest PEEP level by the lowest correspondent driving pressure, which is defined by the difference of plateau pressure, after a modified alveolar recruitment maneuver.

Electrical Impedance Tomography

Other

The setting of the PEEP level above the intersection of the curves representing relative alveolar overdistention and collapse, after a modified alveolar recruitment maneuver.

Primary outcomes

  1. Murray Score (LIS)

    Time frame: 4 hours

    Scoring system for lung injury including hypoxemia, respiratory system compliance, chest radiographic findings and level of PEEP. The minimum value is zero and the maximum value is sixteen. The higher the score the worse outcome.

  2. Potential lung recruitment measured during electrical impedance tomography

    Time frame: 4 hours

    to quantify lung ventilation distribution

Secondary outcomes

  1. Length of days in intensive care unit (ICU days)

    Time frame: Through study completion, an average of 1 year

    to quantify the number of days spent in a critical care unit

  2. Work of breathing (WOB) measured during surface electromyography

    Time frame: 4 hours

    measured in root-mean-squared electromyography signals

  3. Duration of mechanical ventilation (MV days)

    Time frame: Through study completion, an average of 1 year

    to quantity the number of days with use of invasive mechanical ventilation in inpatients.

  4. ICU Mortality

    Time frame: Through study completion, an average of 1 year

    to quantify number of living days between ICU admission and deceased status

  5. respiratory muscle strength

    Time frame: Through study completion, an average of 1 year

    maximal static respiratory mouth pressures

  6. Forced vital capacity (FVC) measured during spirometry

    Time frame: Through study completion, an average of 1 year

    measures obtained by spirometry in outpatients

  7. diaphragmatic mobility measured during ultrasonography

    Time frame: Through study completion, an average of 1 year

    diaphragmatic excursion expressed in millimeters

  8. diaphragmatic thickening measured during ultrasonography

    Time frame: Through study completion, an average of 1 year

    diaphragmatic thickening expressed in millimeters

  9. breathing pattern measured during airway flowmeter

    Time frame: Through study completion, an average of 1 year

    a device to quantify airway flow

  10. peripheral muscle strength I

    Time frame: Through study completion, an average of 1 year

    to be evaluated by Medical Research Council's scale. The minimum score is 0 and the maximum is 60. The higher the score, the better outcome.

  11. peripheral muscle strength II

    Time frame: Through study completion, an average of 1 year

    to be evaluated by a handgrip dynamometers in outpatients

  12. peripheral muscle strength III

    Time frame: Through study completion, an average of 1 year

    to be evaluated by a handheld dynamometer in outpatients

  13. six-minute walk test (6WT)

    Time frame: Through study completion, an average of 1 year

    sub-maximal exercise test used to assess aerobic capacity and endurance in outpatients

  14. functional capacity (Perme scale)

    Time frame: Through study completion, an average of 1 year

    The minimum score is 0 and the maximum is 32. The higher the score, the better outcome.

  15. daily activities performance

    Time frame: Through study completion, an average of 1 year

    to be evaluated by Barthel Index in outpatients

  16. quality of life measured by Short Form Health survey 36

    Time frame: Through study completion, an average of 1 year

    score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

Sponsors and collaborators

Lead sponsor

University of Pernambuco

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Coordination for the Improvement of Higher Education Personnel
  • Fundação de Amparo à Ciência e Tecnologia de Pernambuco
  • Universidade Federal de Pernambuco

Registry information

Official study title

Clinical, Respiratory, Peripheral, Muscle and Functionality Outcomes of Adult ICU Inpatients and Rehabilitation-center Outpatients With COVID-19

Acronym: COVIDPTcare

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Aug 27, 2021
Registry last updated
Mar 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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