Ventilator-Induced Lung InjuryLUNARNCT04484727
"Lung Barometric Measurements in Normal And in Respiratory Distressed Lungs"
An observational study of Ventilator-Induced Lung Injury and Ventilatory Failure, run by Göteborg University at 1 site in Sweden.
Trial summary
Little is known about how lung mechanics are affected during the very early phase after starting mechanical ventilation. Since the conventional method of measuring esophageal pressure is complicated, hard to interpret and expensive, there are no studies on lung mechanics on intensive care patients directly after… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator-Induced Lung Injury, Ventilatory Failure, Ventilator Lung
- What is being tested?
- PEEP-step method
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- 1 May 2022to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: ICU-patients or patients in surgery recieving invasive mechancial ventilation.
Who may be able to join
- Patients above18 years
- ASA 1-3
- Planned/acute ventilator treatment in ICU or OR
Who cannot join
- Patients under 18 years
- ASA 4 and above
- severe COPD/emphysema/heart failure
- PEEP>16 and/or FiO2 >80%
- elevated intracranial pressure
- defect coagulation
- non-treated known or suspected pneumothorax
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Sophie Lindgren
Gothenburg, Västra Götaland County, 41345
Sophie Lindgren, Ass prof, +46313421000 ext. 28587, sophie.lindgren@vgregion.se
Ali Abdulhussein, MD, +46313421000, ali.abdulhussein@vgregion.se
About this study
Little is known about how lung mechanics are affected during the very early phase after starting mechanical ventilation. Since the conventional method of measuring esophageal pressure is complicated, hard to interpret and expensive, there are no studies on lung mechanics on intensive care patients directly after intubation, during the first hours of ventilator treatment and forward until the ventilator treatment is withdrawn. Published studies have collected data using the standard methods from day 1 to 3 of ventilator treatment for respiratory system mechanics, i.e. the combined mechanics of lung and chest wall. Consequently, information on lung mechanical properties during the first critical hours of ventilator treatment is missing and individualization of ventilator care done on the basis of respiratory system mechanics, which are not representative of lung mechanics on an individual patient basis. We have developed a PEEP-step method based on a change of PEEP up and down in one or two steps, where the change in end-expiratory lung volume ΔEELV) is determined and lung compliance calculated as ΔEELV divided by ΔPEEP (CL = ΔEELV/ΔPEEP). This simple non-invasive method for separating lung and chest wall mechanics provides an opportunity to enhance the knowledge of lung compliance and the transpulmonary pressure. After the two-PEEP-step procedure, the PEEP level where transpulmonary driving pressure is lowest can be calculated for any chosen tidal volume.
The aim of the present study in the ICU is to survey lung mechanics from start of mechanical ventilation until extubation and to determine PEEP level with lowest (least injurious) transpulmonary driving pressure during ventilator treatment. The aim of the study during anesthesia in the OR, is to survey lung mechanics in lung healthy and identify patients with lung conditions before anesthesia, which may have an increased risk of postoperative complications.
Read the detailed description
Background:
Acute lung failure requiring respiratory treatment is the most common cause of intensive care in Sweden and the condition has a high mortality rate; approximately 40%. To a large extent, the high mortality rate is due to the patient's underlying disease, e.g. sepsis or trauma but the respiratory treatment itself can also cause mechanical damage to the lungs with the risk of secondary development of acute lung failure and failure in other organ systems such as the liver, kidneys, heart and brain.
In order to reduce the risk and damage of ventilator treatment, it is necessary to improve monitoring of lung function and to develop and evaluate methods for more gentle respiratory treatment.
The studies aim to map the elastic properties of the lungs (pulmonary elastance and transpulmonary drive pressure) in different patient groups, lung healthy and patients with acute lung failure, using the non-invasive PEEP step method. Since the method is non-invasive and is based only on a change in the end expiratory pressure in the ventilator, it can be easily applied during clinical conditions, thus allowing a significant improvement in monitoring and setting of ventilator therapy in both patients under general anesthesia in "major surgery" and patients with acute pulmonary failure in intensive care units.
During general anesthesia, patients lung elasticity will be measured immediately after starting the anesthesia and during surgery and before emergence. In intensive care, the measurement procedure will be applied immediately after the patient has been placed on a ventilator and then during respiratory care when normal intensive care measures take place, such as changing the ventilator setting in terms of breath volume, respiratory rate, end expiratory pressure (PEEP) and similar measures, as well as respiratory suction and inhalations to identify elastic properties within the range normally present in intensive care patients.
Aim:
The aim of the studies is to be able to evaluate lung function during intensive care with new noninvasive measurement methods such as measuring transpulmonary pressure and calculating lung drive pressure, to evaluate lung function during intensive care in order to try to find optimal methods for gentle but effective ventilation of critically ill patients. Studies have previously shown that more gentle respiratory treatment can reduce mortality in respiratory-treated intensive care patients. The development and adaptation of new methods for respiratory treatment and monitoring, can offer better decision support when adjusting airway pressure and volumes, which may ultimately lead to improvements in the form of shorter respiratory time and reduced mortality in respiratory patients. An additional aim is to map normal values of the elastance of the lung ("stiffness") on a population of normal lungs in lung-healthy patients who are sedated for planned surgery.
Main issues:
- Is the measurement with the PEEP step up and down procedure sufficient to accurately present the lung pressure/volume curve and the transpulmonary drive pressure in respiratory-treated patient populations in surgery and ICU?
- Is it possible to collect data on a normal population of lung-healthy patients who are sedated for operative surgery as well as in intensive care patients with different degrees of lung failure with the intention of mapping pulmonary elastance/transpulmonary drive pressure and changes in these parameters at initiation of and during respiratory treatment?
Methods:
The PEEP-step method for determining lung elastane: The elastic properties of the lung are measured by increasing PEEP from the clinical baseline level and then lowering the measurement procedure by setting the breath volume to correspond to the lung volume increase that occurs during the PEEP increase. PEEP and tidal volume changes are very common routine measures in both general anesthesia and intensive care. So far, all analysis has been done through manual calculations off-line, but now the measurement procedure and calculations must be automated as far as possible and the transpulmonal drive pressure is presented breath by breath in order to be used for the individualization of the ventilator treatment bedside. This automation is performed in the form of software development. This work is ongoing and expected to be completed in August 2020. Then the PEEP-step method can be implemented and tested in the clinic.
During ten years, in two doctoral theses and four validation studies and additional lung model studies, the investigators have developed an alternative method for measuring the transpulmonary drive pressure, which does not require oesophageal pressure measurement, but only to make a change in the end expiratory pressure (PEEP) in the ventilator and determine the resulting lung volume increase (DEELV) using the ventilator's volume measurement. The elastic properties of the lung (lung elastane, EL) are calculated as DPEEP/DEELV and then the transpulmonary drive pressure is calculated as the volume of breath of the lung elastance, EL x VT. The above additional measurement methods have been evaluated during the last 15 years. Measurement methods collects data from standard monitoring equipment used in clinical anesthesiological practice since the 1980s.
Protocol:
The study is a longitudinal observational study. Measurements will be performed before, during and after respiratory treatment in patients in intensive care units and in surgical units. The measurements take place during the respiratory care period with focus on variations in lung mechanics before and after the procedures included in the clinical routine regarding respiratory settings and other care. Noninvasive measurement methods will be used (see above) of which no one has a negative impact on the patient. Physiological data will be collected from blood gas analyses and monitoring equipment. The monitoring equipment will be connected to a laptop with software that collects continuous clinical data for analysis.
Informed consent: 1) Adult patients who are about to undergo surgery will be consulted at the preoperative assessment approximately 1-2 weeks before surgery about their participation. 2) In adult intensive care patients treated with respiratory therapy, surrogate consent will be prompted. Since it is not previously predicted which patients will be treated on a ventilator in the intensive care unit, the patient's relatives will be asked for informed consent.
For key-references, se References
- Conditions
- Ventilator-Induced Lung Injury, Ventilatory Failure, Ventilator Lung, Ventilation Therapy; Complications, Ventilator Associated Pneumonia
- Being tested
- PEEP-step method
- Medical subject headings
- Ventilator-Induced Lung Injury, Hypoventilation, Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEP-step methodOther
By changing PEEP in one or two steps up and down, transpulmonary pressure and the lung P/V curve can be determined using a dedicated software collecting data on tidal-volume changes and pressure changes during the PEEP-changes from the standard monitoring equipment or ventilator.
| Study group | Role | What they receive |
|---|---|---|
| ICU-patients in ventilator treatment | Directly after intubation and start of mechanical ventilation, a two-PEEP-step up and down procedure with steps of 5-7 cmH2O each is performed and data on airway pressure and tidal volume changes collected. The data is transferred into a dedicated software for calculation of ΔEELV by cumulative difference in expiratory tidal volume before and during PEEP inflation. Consequently, the lung P/V curve from baseline clinical PEEP to end-inspiration of the highest PEEP level. The PEEP level where clinically used tidal volume has the lowest transpulmonary driving pressure is calculated.
A one-PEEP-step procedure with a step of 5-7 cmH2O is performed when clinical events such as disconnection of the breathing circuit, posture changes, suctioning, inhalation, CO2 insufflation etc. is performed, and repeated during the whole period of ventilator treatment. Receives: Other: PEEP-step method | |
| Surgery-patients during general anaesthesia | Directly after intubation and start of mechanical ventilation, a two-PEEP-step up and down procedure with steps of 5-7 cmH2O each, is performed in the same way as described for ICU patients. Data of airway pressure and volumes are transferred into a dedicated software for calculation of ΔEELV by cumulative difference in expiratory tidal volume before and during PEEP inflation. Consequently, the lung P/V curve from baseline clinical PEEP to end-inspiration of the highest PEEP level. The PEEP level where clinically used tidal volume has the lowest transpulmonary driving pressure is calculated.
A one-PEEP-step procedure with a step of 5-7 cmH2O is performed when clinical events such as disconnection of the breathing circuit, posture changes or suctioning is performed, and before and after implementation of pneumoperitoneum. Receives: Other: PEEP-step method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung-elastance, changes
Data-collection after intubation, during interventions such as suction, inhalation, posture changes
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
Hours/Days of ventilator treatment
Registration of Hours/Days of ventilator treatment
Measured: Through study completion, an average of 1 year
Postoperative complications, ICU-complications
Registration of the most common postoperative and ICU-complications
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start1 May 2022
- Primary completion1 May 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Ventilator-Induced Lung InjuryStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Sahlgrenska University Hospital
- Responsible party
- Sponsor
- Investigators
- Bengt Nellgård, Prof, Study chair, Sahlgrenska Academy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04484727
- Sponsor's protocol ID
- ALF-75130-5027
- Acronym
- LUNAR
- Status last verified
- Mar 2025
- First submitted
- 15 Jul 2020
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lundin S, Grivans C, Stenqvist O. Transpulmonary pressure and lung elastance can be estimated by a PEEP-step manoeuvre. Acta Anaesthesiol Scand. 2015 Feb;59(2):185-96. doi: 10.1111/aas.12442. Epub 2014 Dec 2.
PubMed 25443094Stenqvist O, Grivans C, Andersson B, Lundin S. Lung elastance and transpulmonary pressure can be determined without using oesophageal pressure measurements. Acta Anaesthesiol Scand. 2012 Jul;56(6):738-47. doi: 10.1111/j.1399-6576.2012.02696.x. Epub 2012 Apr 23.
PubMed 22524531Persson P, Lundin S, Stenqvist O. Transpulmonary and pleural pressure in a respiratory system model with an elastic recoiling lung and an expanding chest wall. Intensive Care Med Exp. 2016 Dec;4(1):26. doi: 10.1186/s40635-016-0103-4. Epub 2016 Sep 20.
PubMed 27645151Persson P, Stenqvist O, Lundin S. Evaluation of lung and chest wall mechanics during anaesthesia using the PEEP-step method. Br J Anaesth. 2018 Apr;120(4):860-867. doi: 10.1016/j.bja.2017.11.076. Epub 2017 Dec 1.
PubMed 29576127Stenqvist O, Persson P, Stahl CA, Lundin S. Monitoring transpulmonary pressure during anaesthesia using the PEEP-step method. Br J Anaesth. 2018 Dec;121(6):1373-1375. doi: 10.1016/j.bja.2018.08.018. Epub 2018 Oct 9. No abstract available.
PubMed 30442269Stenqvist O, Persson P, Lundin S. Can we estimate transpulmonary pressure without an esophageal balloon?-yes. Ann Transl Med. 2018 Oct;6(19):392. doi: 10.21037/atm.2018.06.05.
PubMed 30460266
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Lung Barometric Measurements in Normal And in Respiratory Distressed Lungs"
- ClinicalTrials.gov ID
- NCT04484727
- Acronym / sponsor ID
- LUNAR / ALF-75130-5027
- Conditions
- Ventilator-Induced Lung Injury, Ventilatory Failure, Ventilator Lung, Ventilation Therapy; Complications, Ventilator Associated Pneumonia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Sahlgrenska University Hospital
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 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.
Little is known about how lung mechanics are affected during the very early phase after starting mechanical ventilation. Since the conventional method of measuring esophageal pressure is complicated, hard to interpret and expensive, there are no studies on lung mechanics on intensive care patients directly after intubation, during the first hours of ventilator treatment and forward until the ventilator treatment is withdrawn. Published studies have collected data using the standard methods from day 1 to 3 of ventilator treatment for respiratory system mechanics, i.e. the combined mechanics of lung and chest wall. Consequently, information on lung mechanical properties during the first critical hours of ventilator treatment is missing and individualization of ventilator care done on the basis of respiratory system mechanics, which are not representative of lung mechanics on an individual patient basis. We have developed a PEEP-step method based on a change of PEEP up and down in one or two steps, where the change in end-expiratory lung volume ΔEELV) is determined and lung compliance calculated as ΔEELV divided by ΔPEEP (CL = ΔEELV/ΔPEEP). This simple non-invasive method for separating lung and chest wall mechanics provides an opportunity to enhance the knowledge of lung compliance and the transpulmonary pressure. After the two-PEEP-step procedure, the PEEP level where transpulmonary driving pressure is lowest can be calculated for any chosen tidal volume.
The aim of the present study in the ICU is to survey lung mechanics from start of mechanical ventilation until extubation and to determine PEEP level with lowest (least injurious) transpulmonary driving pressure during ventilator treatment. The aim of the study during anesthesia in the OR, is to survey lung mechanics in lung healthy and identify patients with lung conditions before anesthesia, which may have an increased risk of postoperative complications.
Detailed description
Background:
Acute lung failure requiring respiratory treatment is the most common cause of intensive care in Sweden and the condition has a high mortality rate; approximately 40%. To a large extent, the high mortality rate is due to the patient's underlying disease, e.g. sepsis or trauma but the respiratory treatment itself can also cause mechanical damage to the lungs with the risk of secondary development of acute lung failure and failure in other organ systems such as the liver, kidneys, heart and brain.
In order to reduce the risk and damage of ventilator treatment, it is necessary to improve monitoring of lung function and to develop and evaluate methods for more gentle respiratory treatment.
The studies aim to map the elastic properties of the lungs (pulmonary elastance and transpulmonary drive pressure) in different patient groups, lung healthy and patients with acute lung failure, using the non-invasive PEEP step method. Since the method is non-invasive and is based only on a change in the end expiratory pressure in the ventilator, it can be easily applied during clinical conditions, thus allowing a significant improvement in monitoring and setting of ventilator therapy in both patients under general anesthesia in "major surgery" and patients with acute pulmonary failure in intensive care units.
During general anesthesia, patients lung elasticity will be measured immediately after starting the anesthesia and during surgery and before emergence. In intensive care, the measurement procedure will be applied immediately after the patient has been placed on a ventilator and then during respiratory care when normal intensive care measures take place, such as changing the ventilator setting in terms of breath volume, respiratory rate, end expiratory pressure (PEEP) and similar measures, as well as respiratory suction and inhalations to identify elastic properties within the range normally present in intensive care patients.
Aim:
The aim of the studies is to be able to evaluate lung function during intensive care with new noninvasive measurement methods such as measuring transpulmonary pressure and calculating lung drive pressure, to evaluate lung function during intensive care in order to try to find optimal methods for gentle but effective ventilation of critically ill patients. Studies have previously shown that more gentle respiratory treatment can reduce mortality in respiratory-treated intensive care patients. The development and adaptation of new methods for respiratory treatment and monitoring, can offer better decision support when adjusting airway pressure and volumes, which may ultimately lead to improvements in the form of shorter respiratory time and reduced mortality in respiratory patients. An additional aim is to map normal values of the elastance of the lung ("stiffness") on a population of normal lungs in lung-healthy patients who are sedated for planned surgery.
Main issues:
- Is the measurement with the PEEP step up and down procedure sufficient to accurately present the lung pressure/volume curve and the transpulmonary drive pressure in respiratory-treated patient populations in surgery and ICU?
- Is it possible to collect data on a normal population of lung-healthy patients who are sedated for operative surgery as well as in intensive care patients with different degrees of lung failure with the intention of mapping pulmonary elastance/transpulmonary drive pressure and changes in these parameters at initiation of and during respiratory treatment?
Methods:
The PEEP-step method for determining lung elastane: The elastic properties of the lung are measured by increasing PEEP from the clinical baseline level and then lowering the measurement procedure by setting the breath volume to correspond to the lung volume increase that occurs during the PEEP increase. PEEP and tidal volume changes are very common routine measures in both general anesthesia and intensive care. So far, all analysis has been done through manual calculations off-line, but now the measurement procedure and calculations must be automated as far as possible and the transpulmonal drive pressure is presented breath by breath in order to be used for the individualization of the ventilator treatment bedside. This automation is performed in the form of software development. This work is ongoing and expected to be completed in August 2020. Then the PEEP-step method can be implemented and tested in the clinic.
During ten years, in two doctoral theses and four validation studies and additional lung model studies, the investigators have developed an alternative method for measuring the transpulmonary drive pressure, which does not require oesophageal pressure measurement, but only to make a change in the end expiratory pressure (PEEP) in the ventilator and determine the resulting lung volume increase (DEELV) using the ventilator's volume measurement. The elastic properties of the lung (lung elastane, EL) are calculated as DPEEP/DEELV and then the transpulmonary drive pressure is calculated as the volume of breath of the lung elastance, EL x VT. The above additional measurement methods have been evaluated during the last 15 years. Measurement methods collects data from standard monitoring equipment used in clinical anesthesiological practice since the 1980s.
Protocol:
The study is a longitudinal observational study. Measurements will be performed before, during and after respiratory treatment in patients in intensive care units and in surgical units. The measurements take place during the respiratory care period with focus on variations in lung mechanics before and after the procedures included in the clinical routine regarding respiratory settings and other care. Noninvasive measurement methods will be used (see above) of which no one has a negative impact on the patient. Physiological data will be collected from blood gas analyses and monitoring equipment. The monitoring equipment will be connected to a laptop with software that collects continuous clinical data for analysis.
Informed consent: 1) Adult patients who are about to undergo surgery will be consulted at the preoperative assessment approximately 1-2 weeks before surgery about their participation. 2) In adult intensive care patients treated with respiratory therapy, surrogate consent will be prompted. Since it is not previously predicted which patients will be treated on a ventilator in the intensive care unit, the patient's relatives will be asked for informed consent.
For key-references, se References
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICU-patients in ventilator treatment | – | Other: PEEP-step methodDirectly after intubation and start of mechanical ventilation, a two-PEEP-step up and down procedure with steps of 5-7 cmH2O each is performed and data on airway pressure and tidal volume changes collected. The data is transferred into a dedicated software for calculation of ΔEELV by cumulative difference in expiratory tidal volume before and during PEEP inflation. Consequently, the lung P/V curve from baseline clinical PEEP to end-inspiration of the highest PEEP level. The PEEP level where clinically used tidal volume has the lowest transpulmonary driving pressure is calculated. A one-PEEP-step procedure with a step of 5-7 cmH2O is performed when clinical events such as disconnection of the breathing circuit, posture changes, suctioning, inhalation, CO2 insufflation etc. is performed, and repeated during the whole period of ventilator treatment. |
| Surgery-patients during general anaesthesia | – | Other: PEEP-step methodDirectly after intubation and start of mechanical ventilation, a two-PEEP-step up and down procedure with steps of 5-7 cmH2O each, is performed in the same way as described for ICU patients. Data of airway pressure and volumes are transferred into a dedicated software for calculation of ΔEELV by cumulative difference in expiratory tidal volume before and during PEEP inflation. Consequently, the lung P/V curve from baseline clinical PEEP to end-inspiration of the highest PEEP level. The PEEP level where clinically used tidal volume has the lowest transpulmonary driving pressure is calculated. A one-PEEP-step procedure with a step of 5-7 cmH2O is performed when clinical events such as disconnection of the breathing circuit, posture changes or suctioning is performed, and before and after implementation of pneumoperitoneum. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU-patients or patients in surgery recieving invasive mechancial ventilation.
Key inclusion criteria (3 listed)
- Patients above18 years
- ASA 1-3
- Planned/acute ventilator treatment in ICU or OR
Key exclusion criteria (7 listed)
- Patients under 18 years
- ASA 4 and above
- severe COPD/emphysema/heart failure
- PEEP>16 and/or FiO2 >80%
- elevated intracranial pressure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEEP-step methodBy changing PEEP in one or two steps up and down, transpulmonary pressure and the lung P/V curve can be determined using a dedicated software collecting data on tidal-volume changes and pressure changes during the PEEP-changes from the standard monitoring equipment or ventilator. | Other | ICU-patients in ventilator treatment, Surgery-patients during general anaesthesia |
Primary outcome
Lung-elastance, changes
Time frame: Through study completion, an average of 1 year
Data-collection after intubation, during interventions such as suction, inhalation, posture changes
2 secondary outcomes
Hours/Days of ventilator treatment
Time frame: Through study completion, an average of 1 year
Postoperative complications, ICU-complications
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Background: PubMed 25443094Lundin S, Grivans C, Stenqvist O. Transpulmonary pressure and lung elastance can be estimated by a PEEP-step manoeuvre. Acta Anaesthesiol Scand. 2015 Feb;59(2):185-96. doi: 10.1111/aas.12442. Epub 2014 Dec 2.
- Background: PubMed 22524531Stenqvist O, Grivans C, Andersson B, Lundin S. Lung elastance and transpulmonary pressure can be determined without using oesophageal pressure measurements. Acta Anaesthesiol Scand. 2012 Jul;56(6):738-47. doi: 10.1111/j.1399-6576.2012.02696.x. Epub 2012 Apr 23.
- Background: PubMed 27645151Persson P, Lundin S, Stenqvist O. Transpulmonary and pleural pressure in a respiratory system model with an elastic recoiling lung and an expanding chest wall. Intensive Care Med Exp. 2016 Dec;4(1):26. doi: 10.1186/s40635-016-0103-4. Epub 2016 Sep 20.
- Background: PubMed 29576127Persson P, Stenqvist O, Lundin S. Evaluation of lung and chest wall mechanics during anaesthesia using the PEEP-step method. Br J Anaesth. 2018 Apr;120(4):860-867. doi: 10.1016/j.bja.2017.11.076. Epub 2017 Dec 1.
- Background: PubMed 30442269Stenqvist O, Persson P, Stahl CA, Lundin S. Monitoring transpulmonary pressure during anaesthesia using the PEEP-step method. Br J Anaesth. 2018 Dec;121(6):1373-1375. doi: 10.1016/j.bja.2018.08.018. Epub 2018 Oct 9. No abstract available.
- Background: PubMed 30460266Stenqvist O, Persson P, Lundin S. Can we estimate transpulmonary pressure without an esophageal balloon?-yes. Ann Transl Med. 2018 Oct;6(19):392. doi: 10.21037/atm.2018.06.05.
- Grivans C., Transpulmonary pressure during mechanical ventilation. Doctoral thesis. ISBN 978-91-628-8832-9.Link provided by the sponsor.
- Persson P. Lung and chest wall properties during mechanical ventilation. Doctoral thesis. ISBN 978-91-7833-224-3Link provided by the sponsor.
- 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.
Bengt Nellgård, Prof study chair
Sahlgrenska Academy
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 Ventilator-Induced Lung Injury and Ventilatory Failure, run by Göteborg University at 1 site in Sweden.
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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 17 Mar 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sophie Lindgren, Assoc prof (+46313421000 ext. 28587, sophie.lindgren@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung-elastance, changes (time frame: Through study completion, an average of 1 year). 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 NCT04484727, which also lists 6 linked publications.
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 Mar 2025.