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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04471090
Enrollment
32
Registered
2020-07-15
Start date
2020-05-25
Completion date
2022-05-31
Last updated
2025-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness

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.

Interventions

None listed

Sponsors

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Regional ventilation and perfusion distribution ratio60 minutesPercentage of relative ventilation in each Region Of Interest (ROI) in each of the studied positions
Global mechanical compliance and regional impedance compliance60 minutesGlobal mechanical compliance and regional impedance compliance (CZ) for each ROI in each of the studied positions.

Secondary

MeasureTime frameDescription
Assessment of lung mechanics.60 minutesChanges 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)
Assessment of ventilation/perfusion lung distribution.60 minutesChanges 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.
Assesment of changes in ventilation/perfusion in prone position.60 minutesChanges 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.
Assessment of the effects of postural therapy in cases of predominantly unilateral lung pathology60 minutesEffects 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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026