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Clinical Trials/NCT04471090
NCT04471090
Completed
Not Applicable

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

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa1 site in 1 country32 target enrollmentMay 25, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Critical Illness
Sponsor
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Enrollment
32
Locations
1
Primary Endpoint
Global mechanical compliance and regional impedance compliance
Status
Completed
Last Updated
9 months ago

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
May 25, 2020
End Date
May 31, 2022
Last Updated
9 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Responsible Party
Principal Investigator
Principal Investigator

Fernando Suarez Sipmann

MD PhD Intesive Care Medicine

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Eligibility Criteria

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).

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

  • Assessment of lung mechanics.(60 minutes)
  • Assessment of ventilation/perfusion lung distribution.(60 minutes)
  • Assesment of changes in ventilation/perfusion in prone position.(60 minutes)
  • Assessment of the effects of postural therapy in cases of predominantly unilateral lung pathology(60 minutes)

Study Sites (1)

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