Weaning-induced Pulmonary EdemaDEWPOINTNCT07886671
Detecting Early Weaning-induced Pulmonary Oedema Using Lung Impedance Negative Trend During SBT
An observational study of Weaning-induced Pulmonary Edema and Mechanical Ventilation Weaning, run by Unity Health Toronto at 1 site in Canada.
Trial summary
Critically ill patients who require a breathing machine are routinely assessed with a spontaneous breathing trial (SBT) to determine if they can safely breathe on their own. If the trial fails, the breathing machine must be continued. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Weaning-induced Pulmonary Edema, Mechanical Ventilation Weaning, Spontaneous Breathing Trial
- How many people
- 89 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2026to 30 Nov 2028
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who are at higher risk of developing weaning-induced pulmonary edema who are in participating intensive care units (ICU): Medical-Surgical ICU, Trauma-Neuro ICU, and Cardiac ICU
Who may be able to join
- Patients aged 18 years and older
- Patients admitted to an intensive care unit (ICU)
- Patients who are intubated and mechanically ventilated for at least 48 hours
- Patients at increased risk for WIPO, defined as meeting either of the following:
- Presence of known clinical risk factors, including known cardiac dysfunction (defined as dilated, hypertrophic, or hypokinetic cardiopathy or significant valvular disease), COPD, obesity, or metabolic syndrome (three out of hypertension, obesity, high cholesterol, high triglycerides, and diabetes)
- Evidence of weaning failure, defined as ≥1 failed SBT, or ≥1 failed extubation (requiring re-intubation or tracheostomy within 7 days)
Who cannot join
- Patients who have contraindications to EIT monitoring (for example, implanted electrical cardiac devices and chest wall lesions obstructing the application of the EIT belt)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
St. Michael's Hospital
Toronto, Ontario, M5B1W8
Nattapat Wongtirawit, M.D., 4374522523 ext. 6214, nattapat.wongtirawit@unityhealth.to
About this study
Critically ill patients who require a breathing machine are routinely assessed with a spontaneous breathing trial (SBT) to determine if they can safely breathe on their own. If the trial fails, the breathing machine must be continued. One common cause is weaning-induced pulmonary oedema (WIPO), in which the heart cannot handle the increased workload during spontaneous breathing, causing fluid to accumulate in the lungs. Although several markers can suggest WIPO, it is often diagnosed after the SBT has already failed. Earlier recognition could allow clinicians to treat the condition promptly, improving the success rate of subsequent trials.
This study will examine whether electrical impedance tomography (EIT)-a bedside monitor that tracks how air moves in the lungs-can help identify WIPO earlier. We will focus on how lung aeration changes in the first minutes of the trial and whether combining EIT with standard clinical measurements improves early prediction of SBT outcome and identification of WIPO.
Study procedures will take place during routine SBTs and are mostly non-invasive. Participants will undergo EIT monitoring, heart and lung ultrasound, ventilator measurements, and blood tests. Clinical care remains entirely according to the ICU team. Participants will be followed for up to 28 days.
- Conditions
- Weaning-induced Pulmonary Edema, Mechanical Ventilation Weaning, Spontaneous Breathing Trial
- Keywords
- weaning-induced pulmonary edema, mechanical ventilation weaning, spontaneous breathing trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All study participants | Monitoring during a spontaneous breathing trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in end-expiratory lung impedance
A marker derived from electrical impedance tomography that reflects changes in lung volume associated with different treatments; in this case, the change from clinical settings of mechanical ventilation to the spontaneous breathing trial (SBT) settings.
Measured: The entire duration of SBT; routinely planned for 30-120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Oct 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Weaning-induced Pulmonary EdemaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 89 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07886671
- Sponsor's protocol ID
- 26-056
- Acronym
- DEWPOINT
- Status last verified
- Sep 2026
- First submitted
- 14 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets generated and/or analyzed during the current study are not publicly available due participant confidentiality, according to the REB, but are available from the corresponding author on reasonable request.
Publications
Liu J, Shen F, Teboul JL, Anguel N, Beurton A, Bezaz N, Richard C, Monnet X. Cardiac dysfunction induced by weaning from mechanical ventilation: incidence, risk factors, and effects of fluid removal. Crit Care. 2016 Nov 12;20(1):369. doi: 10.1186/s13054-016-1533-9.
PubMed 27836002Longhini F, Maugeri J, Andreoni C, Ronco C, Bruni A, Garofalo E, Pelaia C, Cavicchi C, Pintaudi S, Navalesi P. Electrical impedance tomography during spontaneous breathing trials and after extubation in critically ill patients at high risk for extubation failure: a multicenter observational study. Ann Intensive Care. 2019 Aug 13;9(1):88. doi: 10.1186/s13613-019-0565-0.
PubMed 31410738Shi R, Ayed S, Beuzelin M, Persichini R, Legouge M, Vita NDE, Levy B, Beurton A, Mangal K, Hullin T, Labbe V, Guillot M, Harrois A, Cecconi M, Anguel N, Osman D, Moretto F, Lai C, Pham T, Teboul JL, Monnet X. Incidence and risk factors of weaning-induced pulmonary oedema: results from a multicentre, observational study. Crit Care. 2025 Mar 31;29(1):140. doi: 10.1186/s13054-025-05350-6.
PubMed 40165223Lemaire F, Teboul JL, Cinotti L, Giotto G, Abrouk F, Steg G, Macquin-Mavier I, Zapol WM. Acute left ventricular dysfunction during unsuccessful weaning from mechanical ventilation. Anesthesiology. 1988 Aug;69(2):171-9. doi: 10.1097/00000542-198808000-00004.
PubMed 3044189
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detecting Early Weaning-induced Pulmonary Oedema Using Lung Impedance Negative Trend During SBT
- ClinicalTrials.gov ID
- NCT07886671
- Acronym / sponsor ID
- DEWPOINT / 26-056
- Conditions
- Weaning-induced Pulmonary Edema, Mechanical Ventilation Weaning, Spontaneous Breathing Trial
- Keywords
- weaning-induced pulmonary edema, mechanical ventilation weaning, spontaneous breathing trial
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 89 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 21 Oct 2026 (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.
Critically ill patients who require a breathing machine are routinely assessed with a spontaneous breathing trial (SBT) to determine if they can safely breathe on their own. If the trial fails, the breathing machine must be continued. One common cause is weaning-induced pulmonary oedema (WIPO), in which the heart cannot handle the increased workload during spontaneous breathing, causing fluid to accumulate in the lungs. Although several markers can suggest WIPO, it is often diagnosed after the SBT has already failed. Earlier recognition could allow clinicians to treat the condition promptly, improving the success rate of subsequent trials.
This study will examine whether electrical impedance tomography (EIT)-a bedside monitor that tracks how air moves in the lungs-can help identify WIPO earlier. We will focus on how lung aeration changes in the first minutes of the trial and whether combining EIT with standard clinical measurements improves early prediction of SBT outcome and identification of WIPO.
Study procedures will take place during routine SBTs and are mostly non-invasive. Participants will undergo EIT monitoring, heart and lung ultrasound, ventilator measurements, and blood tests. Clinical care remains entirely according to the ICU team. Participants will be followed for up to 28 days.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All study participants | – | –Monitoring during a spontaneous breathing trial |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are at higher risk of developing weaning-induced pulmonary edema who are in participating intensive care units (ICU): Medical-Surgical ICU, Trauma-Neuro ICU, and Cardiac ICU
Key inclusion criteria (6 listed)
- Patients aged 18 years and older
- Patients admitted to an intensive care unit (ICU)
- Patients who are intubated and mechanically ventilated for at least 48 hours
- Patients at increased risk for WIPO, defined as meeting either of the following:
Key exclusion criteria (1 listed)
- Patients who have contraindications to EIT monitoring (for example, implanted electrical cardiac devices and chest wall lesions obstructing the application of the EIT belt)
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
Changes in end-expiratory lung impedance
Time frame: The entire duration of SBT; routinely planned for 30-120 minutes
A marker derived from electrical impedance tomography that reflects changes in lung volume associated with different treatments; in this case, the change from clinical settings of mechanical ventilation to the spontaneous breathing trial (SBT) settings.
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 21 Oct 2026.
- Background: PubMed 27836002Liu J, Shen F, Teboul JL, Anguel N, Beurton A, Bezaz N, Richard C, Monnet X. Cardiac dysfunction induced by weaning from mechanical ventilation: incidence, risk factors, and effects of fluid removal. Crit Care. 2016 Nov 12;20(1):369. doi: 10.1186/s13054-016-1533-9.
- Background: PubMed 31410738Longhini F, Maugeri J, Andreoni C, Ronco C, Bruni A, Garofalo E, Pelaia C, Cavicchi C, Pintaudi S, Navalesi P. Electrical impedance tomography during spontaneous breathing trials and after extubation in critically ill patients at high risk for extubation failure: a multicenter observational study. Ann Intensive Care. 2019 Aug 13;9(1):88. doi: 10.1186/s13613-019-0565-0.
- Background: PubMed 40165223Shi R, Ayed S, Beuzelin M, Persichini R, Legouge M, Vita NDE, Levy B, Beurton A, Mangal K, Hullin T, Labbe V, Guillot M, Harrois A, Cecconi M, Anguel N, Osman D, Moretto F, Lai C, Pham T, Teboul JL, Monnet X. Incidence and risk factors of weaning-induced pulmonary oedema: results from a multicentre, observational study. Crit Care. 2025 Mar 31;29(1):140. doi: 10.1186/s13054-025-05350-6.
- Background: PubMed 3044189Lemaire F, Teboul JL, Cinotti L, Giotto G, Abrouk F, Steg G, Macquin-Mavier I, Zapol WM. Acute left ventricular dysfunction during unsuccessful weaning from mechanical ventilation. Anesthesiology. 1988 Aug;69(2):171-9. doi: 10.1097/00000542-198808000-00004.
- Individual participant dataSharing planned: No. The datasets generated and/or analyzed during the current study are not publicly available due participant confidentiality, according to the REB, but are available from the corresponding author on reasonable request.
Related trials for Weaning-induced Pulmonary Edema
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Hemodynamic Impact of the Spontaneous Ventilation Test in Patients at Risk of Weaning Pulmonary Oedema
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Recruiting
Systolic Function and Weaning-induced Pulmonary Edema (SystoWean Study)
Mechanical Ventilation Complication, Pulmonary Edema
Recruiting
Ultrasound Evaluation of Cardiac Function During Spontaneous Breathing Trials
Weaning Invasive Mechanical Ventilation, Weaning-induced Pulmonary Edema
Not yet recruiting
Quantification of Systemic Congestion by Ultrasound As a Predictor of Weaning Failure From Mechanical Ventilation
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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.
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 Weaning-induced Pulmonary Edema and Mechanical Ventilation Weaning, run by Unity Health Toronto at 1 site in Canada.
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 6 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: opening soon, as of the sponsor's last update on 21 Oct 2026. 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 Canada. 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 Nattapat Wongtirawit, M.D. (4374522523 ext. 6214, nattapat.wongtirawit@unityhealth.to), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in end-expiratory lung impedance (time frame: The entire duration of SBT; routinely planned for 30-120 minutes). 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 NCT07886671, which also lists 4 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 21 Oct 2026.