Recruitment Assessment in Patients With Acute Respiratory Distress Syndrome and Covid-19

March 9, 2023 updated by: Roberto Santa Cruz, Ramos Mejía Hospital
Respiratory failure associated with Covid-19 can be expressed as acute respiratory distress syndrome (ARDS), which is an acute inflammatory lung injury,which generally requires the use of invasive mechanical ventilation (MV). There are inconclusive results regarding the potential lung recruitment in ARDS. Recently, a new index based on lung compliance has been described to directly quantify the potential for lung recruitment, called the recruitment-inflation index (R/I index). The objective of this study is to prospectively evaluate the recruitment capacity in patients with ARDS and ARDS-Covid-19.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

During the first 7 days of the patient on mechanical ventilation (MV), measurements will be taken. For this, the patient will be in the supine position (DS) or the prone position (DP). The patient will be on a dose of analgesics, under sedation and muscle relaxation and will not present any respiratory stimulus.

Data from MV will also be recorded (prior to recruitment assessment): tidal volume (TV) in milliliters (ml), respiratory rate (RR) in a minute, fraction of inspired oxygen (FiO2), positive end-expiratory pressure (PEEP), in centimeters of water (cmH2O), plateau pressure (Pplat, measured after an end-inspiratory pause, cmH2O), mean airway pressure (PM, cmH2O), minute volume (calculated as the product of RR and TV) in milliliters per minute, ∆P (calculated as Pplat minus PEEP, cmH2O), static compliance (calculated as TV divided by ∆P, ml/cmH2O). Arterial blood gases will also be considered. The proposed recruitment assessment (R/I index) will be compared with another already validated method to evaluate recruitment, such as the measurement of pulmonary hysteresis ratio.For measurements, a ventilator (Neumovent GraphNet Advance-TS, Córdoba Argentina) will be used. Additionally, a dedicated software connected to a computer will be used to perform the measurements.

The following will be assessed: presence of autoPEEP, preset inspiratory tidal volume (TVi), TV exhaled by the ventilator (TVexh) and TV exhaled from high to low PEEP (difference of 10 cm of H2O),during a single maneuver (TVeHL). The measurement will be performed with a high level of PEEP (PEEPH), with values between 15 and 18 cmH2O and a low level of PEEP (PEEPL) with values between 5 and 8 cmH2O. Pplat in PEEPL will also be measured. Additionally, an attempt will be made to determine if there is complete airway closure (a confounder for measurement of alveolar pressure). This is because there are patients who have complete airway closure. In this case, the lungs required an airway opening pressure (AOP) to reopen airways before initiating lung inflation. When AOP is higher than PEEPL, the AOP will be considered as the lower pressure value (instead of PEEPL).

The recruitment index (R/I index) will be as follows:

R/I = (TVexHL - TVexH)/TVi X (Ppl - PEEPL/PEEPH - PEEPL) - 1

TVexH: TV exhaled with PEEPH.

In case of airway closure PEEPL will be replaced by AOP.

A threshold of 0.5 was used to define high recruitability (R/I ratio >= 0.5) and low recruitability (R/I ratio < 0.5).

The evaluation of pressure in relation to volume will also be carried out, through the pressure/volume curve (PV curve), available in the respirator. A low-flow inflation and deflation PV curve from 0 up to 40 cm H2O and from 40 down to 0 cm H2O will be performed using the automatic tool on the ventilator (P/V tool; Neumovent GraphNet Advance-ts, Córdoba Argentina). The P-V curve can be visualized immediately on the screen of the mechanical ventilator and will be taken as a reference method to assess lung recruitment through the hysteresis-like behavior of the respiratory system. Inflation and deflation volume data will be corrected for changes in oxygen consumption.

Ratio hysteresis of the respiratory system will be measured by planimetry using SigmaPlot 12.0 software. There, through a cursor, for the measurement of hysteresis, the place where the volume was greater was drawn and the coincident pressure value was considered. Subsequently the ratio hysteresis was calculated as the ratio between hysteresis and the product of the pressure span and the maximum volume reached (maximum hysteresis). Recruitment potential will be considered if this relationship presents a value > 28%.

Data Analysis. Categorical variables will be presented as number and percentage, while continuous variables will be presented as mean and standard deviation or median and interquartile range, as appropriate. The Chi2 test or Fisher's exact test will be used for qualitative variables and the Student test or the Mann-Whitney U test for quantitative variables. To evaluate correlation, the Pearson or Spearman test will be used, according to the distribution of the evaluated variables. A p ≤ 0.05 will be used.

Study Type

Observational

Enrollment (Anticipated)

41

Contacts and Locations

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

Study Locations

  • Argentina
    • Buenos Aires
      • Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina, C1221ADC
        • Recruiting
        • Hospital Agudos Ramos Mejía

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

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients 15 years of age or older who have been receiving MV in the first 7 days and have been defined as ARDS and ARDS-Covid-19 (with a positive polymerase chain reaction in nasopharyngeal swab samples) according to the clinical criteria of the Berlin definition.

Description

Inclusion Criteria:

- Patients who have been receiving MV with diagnosis of ARDS (Berlin definition) and ARDS-Covid-19.

Exclusion Criteria:

  • Patients with chronic pulmonary disease
  • Patients with a high risk of death within 3 months for reasons other than ARDS-Covid-19
  • Patients having made the decision to withhold life-sustaining treatment.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Potential recruitment of patients with ARDS and ARDS-Covid-19
Time Frame: First 7 days of the patient on mechanical ventilation (MV)

To determine the Recruitment Index (R/I) of patients with ARDS and ARDS-Covid-19.

Tidal volume and pressure will be combined to report the Recruitment Index (R/I) in mL/cmH2O.

A threshold of 0.5 will be used to define high recruitability (R/I ratio >= 0.5 ml/cmH2O) and low recruitability (R/I ratio < 0.5 ml/cmH2O).
First 7 days of the patient on mechanical ventilation (MV)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare the potential recruitment in the supine position (SD) and in the prone position (PD).
Time Frame: First 7 days of the patient on mechanical ventilation (MV)

To compare the R/I (ml/cmH2O) in patients with ARDS and ARDS-Covid-19 in the supine position (SD) and in the prone position (PD).

Tidal volume and pressure will be combined to report the Recruitment Index (R/I) in mL/cmH2O.

A threshold of 0.5 will be used to define high recruitability (R/I ratio >= 0.5 ml/cmH2O) and low recruitability (R/I ratio < 0.5 ml/cmH2O).
First 7 days of the patient on mechanical ventilation (MV)
Correlation between recruitment index (RI) and recruitment assessed by hysteresis ratio.
Time Frame: First 7 days of the patient on mechanical ventilation (MV)

Assess the correlation between recruitment index (RI) and recruitment assessed by the hysteresis ratio (hysteresis and the product of the pressure span and the maximum volume reached (maximum hysteresis) in ml/cmH2O

Tidal volume and pressure will be combined to report the Recruitment Index (R/I) in mL/cmH2O.

Tidal volume and pressure will be combined to report the hysteresis ratio in mL/cmH2O.
First 7 days of the patient on mechanical ventilation (MV)
Assess the relationship between potential recruitment with respiratory parameters.
Time Frame: First 7 days of the patient on mechanical ventilation (MV)

Assess the correlation between IR and respiratory parameters

  • Oxygenation: PaO2/FiO2 (ratio between arterial oxygen pressure and inspired fraction of oxygen).
  • Static compliance (cmH2O)
  • Plateau pressure (cmH2O)
  • ∆P (ml/cmH2O)

Tidal volume and pressure will be combined to report the Recruitment Index (R/I) in mL/cmH2O.
First 7 days of the patient on mechanical ventilation (MV)
Assess the relationship between potential recruitment and clinical parameters.
Time Frame: First 7 days of the patient on mechanical ventilation (MV)

Assess the correlation between IR and clinical parameters:

  • Symptom onset date (FIS) (in case of ARDS-Covid-19)
  • APACHE II (Acute Physiology And Chronic Health Evaluation) score
  • SOFA (Sequential Organ Failure Assessment Score) score
  • Ventilator free days (in days)

Tidal volume and pressure will be combined to report the Recruitment Index (R/I) in mL/cmH2O.
First 7 days of the patient on mechanical ventilation (MV)

Collaborators and Investigators

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

Sponsor

Ramos Mejía Hospital

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)

March 7, 2022

Primary Completion (Actual)

March 7, 2023

Study Completion (Anticipated)

March 1, 2025

Study Registration Dates

First Submitted

February 15, 2022

First Submitted That Met QC Criteria

February 17, 2022

First Posted (Actual)

February 21, 2022

Study Record Updates

Last Update Posted (Estimate)

March 10, 2023

Last Update Submitted That Met QC Criteria

March 9, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hospital General Ramos Mejía

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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