Critical IllnessNCT04471090
Effects of Positional Therapy on Pulmonary Physiology in Patients Undergoing Mechanical Ventilation.
An observational study of Critical Illness, run by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa at 1 site in Spain.
Trial summary
The aim of this project is to evaluate the effects of positional changes in mechanically ventilated patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- How many people
- 32 participants
- Where
- 1 siteSpain
- Study dates
- 25 May 2020to 31 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill patients admitted in the ICU of La Princesa University Hospital, Madrid, Spain.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this project is to evaluate the effects of positional changes in mechanically ventilated patients.
Read the 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.
- Conditions
- Critical Illness
- Medical subject headings
- Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional ventilation and perfusion distribution ratio
Percentage of relative ventilation in each Region Of Interest (ROI) in each of the studied positions
Measured: 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.
Measured: 60 minutes
Secondary outcomes (4)
Assessment of lung mechanics.
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)
Measured: 60 minutes
Assessment of ventilation/perfusion lung distribution.
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.
Measured: 60 minutes
Assesment of changes in ventilation/perfusion in prone position.
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.
Measured: 60 minutes
Assessment of the effects of postural therapy in cases of predominantly unilateral lung pathology
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.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start25 May 2020
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernando Suarez Sipmann, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
- Investigators
- Fernando Suarez Sipmann, MD PhD, Principal investigator, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04471090
- Sponsor's protocol ID
- PT-IMV
- Status last verified
- Jul 2025
- First submitted
- 1 Jul 2020
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huerta MDR, Giralt JAS, Diez-Fernandez A, Alonso MJR, Montes N, Suarez-Sipmann F. Effects of routine postural repositioning on the distribution of lung ventilation and perfusion in mechanically ventilated patients. Intensive Crit Care Nurs. 2025 Apr;87:103952. doi: 10.1016/j.iccn.2025.103952. Epub 2025 Jan 25.
PubMed 39864264
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Positional Therapy on Pulmonary Physiology in Patients Undergoing Mechanical Ventilation.
- ClinicalTrials.gov ID
- NCT04471090
- Acronym / sponsor ID
- PT-IMV
- Conditions
- Critical Illness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Fundación de Investigación Biomédica - Hospital Universitario de La PrincesaUniversity, hospital or other
- Study start
- 25 May 2020 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 15 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients admitted in the ICU of La Princesa University Hospital, Madrid, Spain.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
4 secondary outcomes
Assessment of lung mechanics.
Time frame: 60 minutes
Assessment of ventilation/perfusion lung distribution.
Time frame: 60 minutes
Assesment of changes in ventilation/perfusion in prone position.
Time frame: 60 minutes
Assessment of the effects of postural therapy in cases of predominantly unilateral lung pathology
Time frame: 60 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Derived from this study: PubMed 39864264Huerta MDR, Giralt JAS, Diez-Fernandez A, Alonso MJR, Montes N, Suarez-Sipmann F. Effects of routine postural repositioning on the distribution of lung ventilation and perfusion in mechanically ventilated patients. Intensive Crit Care Nurs. 2025 Apr;87:103952. doi: 10.1016/j.iccn.2025.103952. Epub 2025 Jan 25.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernando Suarez Sipmann, MD PhD principal investigator
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness, run by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regional ventilation and perfusion distribution ratio (time frame: 60 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04471090, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.