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Completed

NCT Number: NCT04471090

Effects of Positional Therapy on Pulmonary Physiology in Patients Undergoing Mechanical Ventilation.

The aim of this project is to evaluate the effects of positional changes in mechanically ventilated patients.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario de La princesa

Madrid, 28006, Spain

About this study

In critically ill patients undergoing invasive mechanical ventilation (IMV), several negative effects converge, promoting the development of collapse in the dorsal areas of the lung. These among others include deep sedation, relaxation, prolonged immobility and the supine position. This results of an added impairment in lung function both in the mechanical and gas exchange. In addition lung collapse contributes to a significant increase in the heterogeneity the distribution of alveolar ventilation and perfusion that may increase the risk of ventilator-induced lung injury (VILI).

Postural therapy is widely recommended as prevention/treatment of pressure ulcers, whose presence, according to the Spanish Society of Intensive Care Medicine (SEMICYUC), is a quality criterion for intensive care units (ICUs), with a prevalence of 18% in these units compared to 7.8% in adult hospitalization. However, how postural changes may affect lung function is an aspect that has been scarcely studied. Given the strong influence of gravity on lung function, positional changes can produce significant alterations in the distribution of trans-pulmonary pressures (a decrease along the vertical gravitational axis of approximately 0.25 cmH2O per cm). Depending on the severity, distribution and location of the respiratory pathology, positional changes may have a significant effect either benefiting or impairing the patient's condition.

The investigators will dynamically assess the effects of routine lateral positioning up to 30-40º by means of electrical impedance tomography (EIT), a non-invasive, radiation-free functional bedside imaging technique that allows to monitor the regional distribution of ventilation and perfusion.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients undergoing IMV under sedation, in a controlled ventilatory modality in passive conditions (i.e. without any spontaneous inspiratory efforts by the patient).
  • Signature of the informed consent by family member or legal representative.

Exclusion criteria

  • Presence of any clinical contraindication for postural therapy, including patient haemodynamic instability, traumatism, pathology or any other cause.
  • Contraindication for the placement of the EIT electrode belt due to unstable spinal cord injury or other skin injuries or wounds in the thoracic region (surgical, traumatic, etc.)
  • Assisted ventilatory modes in a non-passive breathing patient.
  • Hypernatremia
  • Patients with pacemakers or implantable automatic defibrillators (IAD).

Treatment and study plan

Primary outcomes

  1. Regional ventilation and perfusion distribution ratio

    Time frame: 60 minutes

    Percentage of relative ventilation in each Region Of Interest (ROI) in each of the studied positions

  2. Global mechanical compliance and regional impedance compliance

    Time frame: 60 minutes

    Global mechanical compliance and regional impedance compliance (CZ) for each ROI in each of the studied positions.

Secondary outcomes

  1. Assessment of lung mechanics.

    Time frame: 60 minutes

    Changes in the lung mechanics during postural changes in their usual positions: supine position (SD), right lateral position (RLP) at 30º and left lateral position (LLP) at 30º. Global compliance and regional compliance (impedance arbitrary units/cmH2O)

  2. Assessment of ventilation/perfusion lung distribution.

    Time frame: 60 minutes

    Changes in the regional distribution of lung ventilation and perfusion during postural changes in their usual positions: supine position (SD), right lateral position (RLP) at 30º and left lateral position (LLP) at 30º. Percentage of relative ventilation and perfusion distribution in each region of interest (ROI). Relative distribution (%) and derived indexes.

  3. Assesment of changes in ventilation/perfusion in prone position.

    Time frame: 60 minutes

    Changes in ventilation and perfusion in prone position if during the study this circumstance arises due to medical indication. Percentage of relative ventilation and perfusion distribution in each region of interest (ROI). Relative distribution (%) and derived indexes.

  4. Assessment of the effects of postural therapy in cases of predominantly unilateral lung pathology

    Time frame: 60 minutes

    Effects of postural therapy in cases of predominantly unilateral lung pathology. Percentage of relative ventilation and perfusion distribution in each region of interest (ROI). Relative distribution (%) and derived indexes.

Sponsors and collaborators

Lead sponsor

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 15, 2020
Registry last updated
Jul 17, 2025

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

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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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