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

March 5, 2023 updated by: Shirley Lima Campos, University of Pernambuco

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • Pernambuco
      • Recife, Pernambuco, Brazil, 50670-901
        • Physical Therapy Department, Universidade Federal de Pernambuco
      • Recife, Pernambuco, Brazil, 50670-901
        • Hospital das Clinicas - UFPE
      • Recife, Pernambuco, Brazil, 50790-640
        • Hospital da Mulher do Recife
      • Recife, Pernambuco, Brazil, 50920-460
        • Hospital Geral Otavio de Freitas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ADRSNet protocol
ARDSnet protocol is the current, standard of care for ARDS. Its used by setting PEEP and the fraction of inspired oxygen (FiO2) to achieve the oxygenation goal (SpO2 ≥ 93% - accepting the range of 90-96%)
Other: ARDSNet table
The setting of the lowest PEEP level and FiO2 match stated by the table to achieve a goal oxygenation.
Experimental: Driving Pressure (DP)
setting PEEP after performing a modified alveolar recruitment maneuver followed by a decremental PEEP titration electing the level correspondent to the lowest driving pressure.
Other: Driving Pressure
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.
Experimental: Electrical Impedance Tomography (EIT)
After performing a modified alveolar recruitment maneuver, the PEEP decremental titration guided by the EIT will be set at the level above the intersection of the curves representing relative alveolar overdistention and collapse.
Other: Electrical Impedance Tomography
The setting of the PEEP level above the intersection of the curves representing relative alveolar overdistention and collapse, after a modified alveolar recruitment maneuver.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 hours
Potential lung recruitment measured during electrical impedance tomography
Time Frame: 4 hours
to quantify lung ventilation distribution
4 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through study completion, an average of 1 year
Work of breathing (WOB) measured during surface electromyography
Time Frame: 4 hours
measured in root-mean-squared electromyography signals
4 hours
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.
Through study completion, an average of 1 year
ICU Mortality
Time Frame: Through study completion, an average of 1 year
to quantify number of living days between ICU admission and deceased status
Through study completion, an average of 1 year
respiratory muscle strength
Time Frame: Through study completion, an average of 1 year
maximal static respiratory mouth pressures
Through study completion, an average of 1 year
Forced vital capacity (FVC) measured during spirometry
Time Frame: Through study completion, an average of 1 year
measures obtained by spirometry in outpatients
Through study completion, an average of 1 year
diaphragmatic mobility measured during ultrasonography
Time Frame: Through study completion, an average of 1 year
diaphragmatic excursion expressed in millimeters
Through study completion, an average of 1 year
diaphragmatic thickening measured during ultrasonography
Time Frame: Through study completion, an average of 1 year
diaphragmatic thickening expressed in millimeters
Through study completion, an average of 1 year
breathing pattern measured during airway flowmeter
Time Frame: Through study completion, an average of 1 year
a device to quantify airway flow
Through study completion, an average of 1 year
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.
Through study completion, an average of 1 year
peripheral muscle strength II
Time Frame: Through study completion, an average of 1 year
to be evaluated by a handgrip dynamometers in outpatients
Through study completion, an average of 1 year
peripheral muscle strength III
Time Frame: Through study completion, an average of 1 year
to be evaluated by a handheld dynamometer in outpatients
Through study completion, an average of 1 year
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
Through study completion, an average of 1 year
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.
Through study completion, an average of 1 year
daily activities performance
Time Frame: Through study completion, an average of 1 year
to be evaluated by Barthel Index in outpatients
Through study completion, an average of 1 year
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.
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pernambuco

Collaborators

Universidade Federal de Pernambuco
Coordination for the Improvement of Higher Education Personnel (CAPES)
Pernambuco Research Foundation (FACEPE)
Brazilian National Council for Scientific and Technological Development (CNPq)

Investigators

  • Study Director: Shirley Lima Campos, PhD, Universidade Federal de Pernambuco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2020

Primary Completion (Actual)

July 11, 2021

Study Completion (Actual)

December 30, 2022

Study Registration Dates

First Submitted

December 18, 2020

First Submitted That Met QC Criteria

August 25, 2021

First Posted (Actual)

August 27, 2021

Study Record Updates

Last Update Posted (Estimate)

March 7, 2023

Last Update Submitted That Met QC Criteria

March 5, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVIDPTcare

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

  • participant characteristics (age, gender)
  • clinical measurements (blood pressure, heart rate)
  • medical history
  • clinical laboratory results
  • images (X-rays)
  • adverse events (hemodynamic and respiratory instability, interruptions)
  • details of randomisation and treatment received

IPD Sharing Time Frame

end of trial

IPD Sharing Access Criteria

individual participant data (IPD) access will be granted by the PI after request review for approval via email. It will be shared with researchers and general public of interest on the subject for descriptive analyses related to our sample medical and clinical characteristics. A committee of researchers will be in charge of discussing the request before approving the access.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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