Asynchrony, Patient-VentilatorNCT06494215
Comparison of Different Methods to Calculate Pendelluft by Electrical Impedance Tomography in Mechanically Ventilated Patients
A study testing Pressure Support Variation and Calculation of Respiratory Mechanics in people with Asynchrony, Patient-Ventilator and ARDS, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The Pendelluft phenomenon is an important cause of lung damage in spontaneously breathing mechanically ventilated patients since it considerably increases the stress on the lung parenchyma in the dependent areas. It can result in a local driving pressure up to three times higher than the global driving pressure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asynchrony, Patient-Ventilator, ARDS, Respiratory Insufficiency
- What is being tested?
- Pressure Support Variation and Calculation of Respiratory Mechanics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBrazil
- Study dates
- 11 Jun 2024to 11 Jun 2025
- Phase
- Interventional
- 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
Who may be able to join
- Patients under invasive mechanical ventilation intubated due to respiratory failure in pressure support mode (weaning phase)
Who cannot join
- Age less than 18 years; sedation or neuromuscular blockade; absence of respiratory effort; contraindications to esophageal balloon cathether positioning or electrical impedance tomography belt positioning; presence of pneumothorax or active air leaks; hemodynamic instability; absence of informed consent.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP
São Paulo, 05403-900
Marcelo BP Amato, MD, PhD, 3061-7361, marcelo.amato@hc.fm.usp.br
Ana C Cardoso dos Santos, PT, +5511968022077, cardosocsfisio@gmail.com
About this study
Official title: Comparison of Different Methods to Calculate Pendelluft by Electrical Impedance Tomography in Patients Undergoing Invasive Mechanical Ventilation Under Pressure Support Mode
The Pendelluft phenomenon is an important cause of lung damage in spontaneously breathing mechanically ventilated patients since it considerably increases the stress on the lung parenchyma in the dependent areas. It can result in a local driving pressure up to three times higher than the global driving pressure. The measurement of Pendelluft is still uncertain in the literature, and although various methods have been proposed, not all have the same meaning in terms of pulmonary overstress and overstrain. This study proposes a comparative analysis of different ways to calculate and estimate the stress imposed on the lung parenchyma by Pendelluft in terms of regional volume and local driving pressure through electrical impedance tomography.
Read the detailed description
Respiratory mechanics and regional ventilation will be monitored by electrical impedance tomography (Enlight 1800 and 2100, Timpel). Esophageal and gastric pressures will be obtained by placing an esophageal/gastric balloon cathether (Nutrivent ®), validation concerning position will be done through modified Baydur maneuver (delta esophageal/delta airway pressure = 0.8-1.2). The hardware Pneumodrive will be used to inflate the balloon and store the airway, gastric and esophageal pressures.
Initially the patients will be monitored with EIT for aproximately 30 minutes after pletismography stabilization. Then, an arterial blood-gas sample shall be collected for analysis. Next, three expiratory and three inspiratory pauses of at least two seconds will be realized with intervals of eight respiratory cycles between them, allowing plateau pressure to be recorded and global and regional driving pressure to be estimated. All this data will be stored for later analysis. The same procedures and measurements shall be made sequentially with a 50% higher pressure support and with a 50% lower pressure support.
- Conditions
- Asynchrony, Patient-Ventilator, ARDS, Respiratory Insufficiency, Respiratory Effort-Related Arousal | Patient | Respiratory Measures and Ventilator Management
- Being tested
- Pressure Support Variation and Calculation of Respiratory Mechanics
- Keywords
- Pendelluft, Ventilator-patient asynchrony, Patient self-induced lung injury, ARDS, Respiratory failure, Electrical Impedance Tomography
- Medical subject headings
- Patient-Ventilator Asynchrony, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure Support Variation and Calculation of Respiratory MechanicsOther
Patients will be submitted to different levels of pressure support (PS) in a randomly assigned order. First 30 minutes shall be recorded at the clinical PS. Next, blood gas samples shall be collected. Subsequently, three inspiratory pauses of at least 2 seconds shall be performed with an interval of at least 8 respiratory cycles between them. The same shall be performed with three expiratory pauses. Next, the PS shall be varied to 50% less or 50% more than clinical PS (based on randomization) and the same procedures shall be performed after 30 minutes of data recording (blood gas sample collection, inspiratory and expiratory pauses). All data shall be analyzed offline using a software that will be able to compare three different methods to calculate Pendelluft magnitude based on the literature. After completion of the protocol, ventilatory parameters shall be returned to the original settings. If the patient becomes tachypneic during lower PS, the protocol shall be interrupted.
| Study group | Role | What they receive |
|---|---|---|
| Pressure Support Variation | Other | Patients shall be submitted to pressure support variation in a randomly assigned manner. First 30 minutes after plethysmogram stabilization shall be recorded at clinical pressure support. Next, a blood gas sample shall be collected by a nurse or a physician, and three inspiratory pauses of at least 2 seconds shall be performed in between eight respiratory cycles. Next three expiratory pauses shall be performed in between eight respiratory cycles. All data shall be recorded and analysed offline. Subsequently the same sequence of events shall be performed at a 50% higher pressure support and at a 50% lower pressure support. The sequence in which this will happen shall be randomly assigned (first lower PS vs higher PS or first higher PS vs lower PS). Receives: Other: Pressure Support Variation and Calculation of Respiratory Mechanics |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Magnitude of Pendelluft
Three differents methods of estimating magnitude of Pendelluft shall be compared using a software based on electrical impedance tomography monitoring (Enlight 2100, Timpel Medical®, Brazil)
Measured: During 30 minutes after plethysmogram stabilization at clinical PS, during 30 minutes at 50% lower PS, and during 30 minutes at 50% higher PS
2. Magnitude of Pendelluft during inspiratory pause
One of the methods of Pendelluft measurement shall be performed during an inspiratory pause for comparison with a normal cycle (without pause).
Measured: During 30 minutes after plethysmogram stabilization at clinical PS, during 30 minutes at 50% lower PS, and during 30 minutes at 50% higher PS
3. Magnitude of respiratory effort
Respiratory effort shall be estimated through expiratory pauses and though recording of esophageal pressure at different pressure support levels. These data shall be compared to Pendelluft magnitude according to the different methods of calculation
Measured: During 30 minutes after plethysmogram stabilization at clinical PS, during 30 minutes at 50% lower PS, and during 30 minutes at 50% higher PS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start11 Jun 2024
- Primary completion11 Jun 2025 (estimated)
- Study completion11 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Asynchrony, Patient-VentilatorStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All the participants shall be exposed to the same situations (variation of pressure support and inspiratory/expiratory pauses)
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marcelo BP Amato, Principal investigator, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06494215
- Sponsor's protocol ID
- 79317924.0.0000.0068
- Status last verified
- Jun 2024
- First submitted
- 2 Jul 2024
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Putensen C, Zech S, Wrigge H, Zinserling J, Stuber F, Von Spiegel T, Mutz N. Long-term effects of spontaneous breathing during ventilatory support in patients with acute lung injury. Am J Respir Crit Care Med. 2001 Jul 1;164(1):43-9. doi: 10.1164/ajrccm.164.1.2001078.
PubMed 11435237Sassoon CS, Zhu E, Caiozzo VJ. Assist-control mechanical ventilation attenuates ventilator-induced diaphragmatic dysfunction. Am J Respir Crit Care Med. 2004 Sep 15;170(6):626-32. doi: 10.1164/rccm.200401-042OC. Epub 2004 Jun 16.
PubMed 15201132Yoshida T, Uchiyama A, Matsuura N, Mashimo T, Fujino Y. Spontaneous breathing during lung-protective ventilation in an experimental acute lung injury model: high transpulmonary pressure associated with strong spontaneous breathing effort may worsen lung injury. Crit Care Med. 2012 May;40(5):1578-85. doi: 10.1097/CCM.0b013e3182451c40.
PubMed 22430241Yoshida T, Fujino Y, Amato MB, Kavanagh BP. Fifty Years of Research in ARDS. Spontaneous Breathing during Mechanical Ventilation. Risks, Mechanisms, and Management. Am J Respir Crit Care Med. 2017 Apr 15;195(8):985-992. doi: 10.1164/rccm.201604-0748CP.
PubMed 27786562Yoshida T, Torsani V, Gomes S, De Santis RR, Beraldo MA, Costa EL, Tucci MR, Zin WA, Kavanagh BP, Amato MB. Spontaneous effort causes occult pendelluft during mechanical ventilation. Am J Respir Crit Care Med. 2013 Dec 15;188(12):1420-7. doi: 10.1164/rccm.201303-0539OC.
PubMed 24199628Arellano DH, Brito R, Morais CCA, Ruiz-Rudolph P, Gajardo AIJ, Guinez DV, Lazo MT, Ramirez I, Rojas VA, Cerda MA, Medel JN, Illanes V, Estuardo NR, Bruhn AR, Brochard LJ, Amato MBP, Cornejo RA. Pendelluft in hypoxemic patients resuming spontaneous breathing: proportional modes versus pressure support ventilation. Ann Intensive Care. 2023 Dec 20;13(1):131. doi: 10.1186/s13613-023-01230-w.
PubMed 38117367Bellani G, Grasselli G, Teggia-Droghi M, Mauri T, Coppadoro A, Brochard L, Pesenti A. Do spontaneous and mechanical breathing have similar effects on average transpulmonary and alveolar pressure? A clinical crossover study. Crit Care. 2016 Apr 28;20(1):142. doi: 10.1186/s13054-016-1290-9.
PubMed 27160458Cornejo RA, Arellano DH, Ruiz-Rudolph P, Guinez DV, Morais CCA, Gajardo AIJ, Lazo MT, Brito RE, Cerda MA, Gonzalez SJ, Rojas VA, Diaz GA, Lopez LDM, Medel JN, Soto DI, Bruhn AR, Amato MBP, Estuardo NR. Inflammatory biomarkers and pendelluft magnitude in ards patients transitioning from controlled to partial support ventilation. Sci Rep. 2022 Nov 23;12(1):20233. doi: 10.1038/s41598-022-24412-1.
PubMed 36418386Frerichs I, Amato MB, van Kaam AH, Tingay DG, Zhao Z, Grychtol B, Bodenstein M, Gagnon H, Bohm SH, Teschner E, Stenqvist O, Mauri T, Torsani V, Camporota L, Schibler A, Wolf GK, Gommers D, Leonhardt S, Adler A; TREND study group. Chest electrical impedance tomography examination, data analysis, terminology, clinical use and recommendations: consensus statement of the TRanslational EIT developmeNt stuDy group. Thorax. 2017 Jan;72(1):83-93. doi: 10.1136/thoraxjnl-2016-208357. Epub 2016 Sep 5.
PubMed 27596161Su PL, Zhao Z, Ko YF, Chen CW, Cheng KS. Spontaneous Breathing and Pendelluft in Patients with Acute Lung Injury: A Narrative Review. J Clin Med. 2022 Dec 15;11(24):7449. doi: 10.3390/jcm11247449.
PubMed 36556064Coppadoro A, Grassi A, Giovannoni C, Rabboni F, Eronia N, Bronco A, Foti G, Fumagalli R, Bellani G. Occurrence of pendelluft under pressure support ventilation in patients who failed a spontaneous breathing trial: an observational study. Ann Intensive Care. 2020 Apr 7;10(1):39. doi: 10.1186/s13613-020-00654-y.
PubMed 32266600Sang L, Zhao Z, Yun PJ, Frerichs I, Moller K, Fu F, Liu X, Zhong N, Li Y. Qualitative and quantitative assessment of pendelluft: a simple method based on electrical impedance tomography. Ann Transl Med. 2020 Oct;8(19):1216. doi: 10.21037/atm-20-4182.
PubMed 33178748Chi Y, Zhao Z, Frerichs I, Long Y, He H. Prevalence and prognosis of respiratory pendelluft phenomenon in mechanically ventilated ICU patients with acute respiratory failure: a retrospective cohort study. Ann Intensive Care. 2022 Mar 5;12(1):22. doi: 10.1186/s13613-022-00995-w.
PubMed 35246748Bellani G, Grassi A, Sosio S, Gatti S, Kavanagh BP, Pesenti A, Foti G. Driving Pressure Is Associated with Outcome during Assisted Ventilation in Acute Respiratory Distress Syndrome. Anesthesiology. 2019 Sep;131(3):594-604. doi: 10.1097/ALN.0000000000002846.
PubMed 31335543Bellani G, Grassi A, Sosio S, Foti G. Plateau and driving pressure in the presence of spontaneous breathing. Intensive Care Med. 2019 Jan;45(1):97-98. doi: 10.1007/s00134-018-5311-9. Epub 2018 Jul 13. No abstract available.
PubMed 30006893
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Methods to Calculate Pendelluft by Electrical Impedance Tomography in Patients Undergoing Invasive Mechanical Ventilation Under Pressure Support Mode
- ClinicalTrials.gov ID
- NCT06494215
- Acronym / sponsor ID
- 79317924.0.0000.0068
- Conditions
- Asynchrony, Patient-Ventilator, ARDS, Respiratory Insufficiency, Respiratory Effort-Related Arousal | Patient | Respiratory Measures and Ventilator Management
- Keywords
- Pendelluft, Ventilator-patient asynchrony, Patient self-induced lung injury, ARDS, Respiratory failure, Electrical Impedance Tomography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 11 Jun 2024 (actual)
- Primary completion
- 11 Jun 2025 (estimated)
- Study completion
- 11 Jun 2025 (estimated)
- First posted
- 10 Jul 2024 (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 Pendelluft phenomenon is an important cause of lung damage in spontaneously breathing mechanically ventilated patients since it considerably increases the stress on the lung parenchyma in the dependent areas. It can result in a local driving pressure up to three times higher than the global driving pressure. The measurement of Pendelluft is still uncertain in the literature, and although various methods have been proposed, not all have the same meaning in terms of pulmonary overstress and overstrain. This study proposes a comparative analysis of different ways to calculate and estimate the stress imposed on the lung parenchyma by Pendelluft in terms of regional volume and local driving pressure through electrical impedance tomography.
Detailed description
Respiratory mechanics and regional ventilation will be monitored by electrical impedance tomography (Enlight 1800 and 2100, Timpel). Esophageal and gastric pressures will be obtained by placing an esophageal/gastric balloon cathether (Nutrivent ®), validation concerning position will be done through modified Baydur maneuver (delta esophageal/delta airway pressure = 0.8-1.2). The hardware Pneumodrive will be used to inflate the balloon and store the airway, gastric and esophageal pressures.
Initially the patients will be monitored with EIT for aproximately 30 minutes after pletismography stabilization. Then, an arterial blood-gas sample shall be collected for analysis. Next, three expiratory and three inspiratory pauses of at least two seconds will be realized with intervals of eight respiratory cycles between them, allowing plateau pressure to be recorded and global and regional driving pressure to be estimated. All this data will be stored for later analysis. The same procedures and measurements shall be made sequentially with a 50% higher pressure support and with a 50% lower pressure support.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All the participants shall be exposed to the same situations (variation of pressure support and inspiratory/expiratory pauses)
| Arm | Type | Receives |
|---|---|---|
| Pressure Support Variation | Other | Other: Pressure Support Variation and Calculation of Respiratory MechanicsPatients shall be submitted to pressure support variation in a randomly assigned manner. First 30 minutes after plethysmogram stabilization shall be recorded at clinical pressure support. Next, a blood gas sample shall be collected by a nurse or a physician, and three inspiratory pauses of at least 2 seconds shall be performed in between eight respiratory cycles. Next three expiratory pauses shall be performed in between eight respiratory cycles. All data shall be recorded and analysed offline. Subsequently the same sequence of events shall be performed at a 50% higher pressure support and at a 50% lower pressure support. The sequence in which this will happen shall be randomly assigned (first lower PS vs higher PS or first higher PS vs lower PS). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients under invasive mechanical ventilation intubated due to respiratory failure in pressure support mode (weaning phase)
Key exclusion criteria (1 listed)
- Age less than 18 years; sedation or neuromuscular blockade; absence of respiratory effort; contraindications to esophageal balloon cathether positioning or electrical impedance tomography belt positioning; presence of pneumothorax or active air leaks; hemodynamic instability; absence of informed consent.
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 |
|---|---|---|
| Pressure Support Variation and Calculation of Respiratory MechanicsPatients will be submitted to different levels of pressure support (PS) in a randomly assigned order. First 30 minutes shall be recorded at the clinical PS. Next, blood gas samples shall be collected. Subsequently, three inspiratory pauses of at least 2 seconds shall be performed with an interval of at least 8 respiratory cycles between them. The same shall be performed with three expiratory pauses. Next, the PS shall be varied to 50% less or 50% more than clinical PS (based on randomization) and the same procedures shall be performed after 30 minutes of data recording (blood gas sample collection, inspiratory and expiratory pauses). All data shall be analyzed offline using a software that will be able to compare three different methods to calculate Pendelluft magnitude based on the literature. After completion of the protocol, ventilatory parameters shall be returned to the original settings. If the patient becomes tachypneic during lower PS, the protocol shall be interrupted. | Other | Pressure Support Variation |
Primary outcome
1. Magnitude of Pendelluft
Time frame: During 30 minutes after plethysmogram stabilization at clinical PS, during 30 minutes at 50% lower PS, and during 30 minutes at 50% higher PS
Three differents methods of estimating magnitude of Pendelluft shall be compared using a software based on electrical impedance tomography monitoring (Enlight 2100, Timpel Medical®, Brazil)
2. Magnitude of Pendelluft during inspiratory pause
Time frame: During 30 minutes after plethysmogram stabilization at clinical PS, during 30 minutes at 50% lower PS, and during 30 minutes at 50% higher PS
One of the methods of Pendelluft measurement shall be performed during an inspiratory pause for comparison with a normal cycle (without pause).
3. Magnitude of respiratory effort
Time frame: During 30 minutes after plethysmogram stabilization at clinical PS, during 30 minutes at 50% lower PS, and during 30 minutes at 50% higher PS
Respiratory effort shall be estimated through expiratory pauses and though recording of esophageal pressure at different pressure support levels. These data shall be compared to Pendelluft magnitude according to the different methods of calculation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Background: PubMed 11435237Putensen C, Zech S, Wrigge H, Zinserling J, Stuber F, Von Spiegel T, Mutz N. Long-term effects of spontaneous breathing during ventilatory support in patients with acute lung injury. Am J Respir Crit Care Med. 2001 Jul 1;164(1):43-9. doi: 10.1164/ajrccm.164.1.2001078.
- Background: PubMed 15201132Sassoon CS, Zhu E, Caiozzo VJ. Assist-control mechanical ventilation attenuates ventilator-induced diaphragmatic dysfunction. Am J Respir Crit Care Med. 2004 Sep 15;170(6):626-32. doi: 10.1164/rccm.200401-042OC. Epub 2004 Jun 16.
- Background: PubMed 22430241Yoshida T, Uchiyama A, Matsuura N, Mashimo T, Fujino Y. Spontaneous breathing during lung-protective ventilation in an experimental acute lung injury model: high transpulmonary pressure associated with strong spontaneous breathing effort may worsen lung injury. Crit Care Med. 2012 May;40(5):1578-85. doi: 10.1097/CCM.0b013e3182451c40.
- Background: PubMed 27786562Yoshida T, Fujino Y, Amato MB, Kavanagh BP. Fifty Years of Research in ARDS. Spontaneous Breathing during Mechanical Ventilation. Risks, Mechanisms, and Management. Am J Respir Crit Care Med. 2017 Apr 15;195(8):985-992. doi: 10.1164/rccm.201604-0748CP.
- Background: PubMed 24199628Yoshida T, Torsani V, Gomes S, De Santis RR, Beraldo MA, Costa EL, Tucci MR, Zin WA, Kavanagh BP, Amato MB. Spontaneous effort causes occult pendelluft during mechanical ventilation. Am J Respir Crit Care Med. 2013 Dec 15;188(12):1420-7. doi: 10.1164/rccm.201303-0539OC.
- Background: PubMed 38117367Arellano DH, Brito R, Morais CCA, Ruiz-Rudolph P, Gajardo AIJ, Guinez DV, Lazo MT, Ramirez I, Rojas VA, Cerda MA, Medel JN, Illanes V, Estuardo NR, Bruhn AR, Brochard LJ, Amato MBP, Cornejo RA. Pendelluft in hypoxemic patients resuming spontaneous breathing: proportional modes versus pressure support ventilation. Ann Intensive Care. 2023 Dec 20;13(1):131. doi: 10.1186/s13613-023-01230-w.
- Background: PubMed 27160458Bellani G, Grasselli G, Teggia-Droghi M, Mauri T, Coppadoro A, Brochard L, Pesenti A. Do spontaneous and mechanical breathing have similar effects on average transpulmonary and alveolar pressure? A clinical crossover study. Crit Care. 2016 Apr 28;20(1):142. doi: 10.1186/s13054-016-1290-9.
- Background: PubMed 36418386Cornejo RA, Arellano DH, Ruiz-Rudolph P, Guinez DV, Morais CCA, Gajardo AIJ, Lazo MT, Brito RE, Cerda MA, Gonzalez SJ, Rojas VA, Diaz GA, Lopez LDM, Medel JN, Soto DI, Bruhn AR, Amato MBP, Estuardo NR. Inflammatory biomarkers and pendelluft magnitude in ards patients transitioning from controlled to partial support ventilation. Sci Rep. 2022 Nov 23;12(1):20233. doi: 10.1038/s41598-022-24412-1.
- Background: PubMed 27596161Frerichs I, Amato MB, van Kaam AH, Tingay DG, Zhao Z, Grychtol B, Bodenstein M, Gagnon H, Bohm SH, Teschner E, Stenqvist O, Mauri T, Torsani V, Camporota L, Schibler A, Wolf GK, Gommers D, Leonhardt S, Adler A; TREND study group. Chest electrical impedance tomography examination, data analysis, terminology, clinical use and recommendations: consensus statement of the TRanslational EIT developmeNt stuDy group. Thorax. 2017 Jan;72(1):83-93. doi: 10.1136/thoraxjnl-2016-208357. Epub 2016 Sep 5.
- Background: PubMed 36556064Su PL, Zhao Z, Ko YF, Chen CW, Cheng KS. Spontaneous Breathing and Pendelluft in Patients with Acute Lung Injury: A Narrative Review. J Clin Med. 2022 Dec 15;11(24):7449. doi: 10.3390/jcm11247449.
- Background: PubMed 32266600Coppadoro A, Grassi A, Giovannoni C, Rabboni F, Eronia N, Bronco A, Foti G, Fumagalli R, Bellani G. Occurrence of pendelluft under pressure support ventilation in patients who failed a spontaneous breathing trial: an observational study. Ann Intensive Care. 2020 Apr 7;10(1):39. doi: 10.1186/s13613-020-00654-y.
- Background: PubMed 33178748Sang L, Zhao Z, Yun PJ, Frerichs I, Moller K, Fu F, Liu X, Zhong N, Li Y. Qualitative and quantitative assessment of pendelluft: a simple method based on electrical impedance tomography. Ann Transl Med. 2020 Oct;8(19):1216. doi: 10.21037/atm-20-4182.
- 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.
Marcelo BP Amato principal investigator
University of Sao Paulo General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pressure Support Variation and Calculation of Respiratory Mechanics in people with Asynchrony, Patient-Ventilator and ARDS, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 10 Jul 2024. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcelo BP Amato, MD PhD (3061-7361, marcelo.amato@hc.fm.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Magnitude of Pendelluft (time frame: During 30 minutes after plethysmogram stabilization at clinical PS, during 30 minutes at 50% lower PS, and during 30 minutes at 50% higher PS). The study lists 3 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 NCT06494215, which also lists 16 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 10 Jul 2024.