Effects of Positional Therapy on Pulmonary Physiology in Patients Undergoing Mechanical Ventilation.
1 other identifier
observational
32
1 country
1
Brief Summary
The aim of this project is to evaluate the effects of positional changes in mechanically ventilated patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 25, 2020
CompletedFirst Submitted
Initial submission to the registry
July 1, 2020
CompletedFirst Posted
Study publicly available on registry
July 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2022
CompletedJuly 17, 2025
July 1, 2025
2 years
July 1, 2020
July 14, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Regional ventilation and perfusion distribution ratio
Percentage of relative ventilation in each Region Of Interest (ROI) in each of the studied positions
60 minutes
Global mechanical compliance and regional impedance compliance
Global mechanical compliance and regional impedance compliance (CZ) for each ROI in each of the studied positions.
60 minutes
Secondary Outcomes (4)
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
Eligibility Criteria
Critically ill patients admitted in the ICU of La Princesa University Hospital, Madrid, Spain.
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Universitario de La princesa
Madrid, Madrid, 28006, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fernando Suarez Sipmann, MD PhD
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD PhD Intesive Care Medicine
Study Record Dates
First Submitted
July 1, 2020
First Posted
July 15, 2020
Study Start
May 25, 2020
Primary Completion
May 31, 2022
Study Completion
May 31, 2022
Last Updated
July 17, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share