Detecting Early Weaning-induced Pulmonary Oedema Using Lung Impedance Negative Trend During SBT

NCT07886671 — Not yet recruiting, 89 participants, Unity Health Toronto

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RegistryNCT07886671, acronym DEWPOINT
StatusNot yet recruiting
Study typeObservational
Enrollment89 (Estimated)
SponsorUnity Health Toronto (Other)
ConditionsWeaning-induced Pulmonary Edema, Mechanical Ventilation Weaning, Spontaneous Breathing Trial
Datesstart 2026-11-01 (estimated), primary completion 2028-10-31 (estimated), completion 2028-11-30 (estimated), first posted 2026-10-21, last updated 2026-10-21
Locations1 site in Canada

Related Papers Related Patents Related Grants Related Experts
All trials for Weaning-induced Pulmonary Edema All trials for Mechanical Ventilation Weaning

-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. 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.

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+Arms and interventions

ArmTypeInterventionsDescription
All study participantsMonitoring during a spontaneous breathing trial

+Outcome measures

Primary outcomes

  • Changes in end-expiratory lung impedance [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.

Other outcomes

  • Left atrial strain index [The entire duration of SBT; routinely planned for 30-120 minutes]: Echocardiography-derived parameter that quantifies the wall strain of the left atrium, reflecting the dynamic changes in volume and pressure status.

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

Inclusion Criteria:

* 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:

  1. 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)
  2. Evidence of weaning failure, defined as ≥1 failed SBT, or ≥1 failed extubation (requiring re-intubation or tracheostomy within 7 days)

Exclusion Criteria:

* Patients who have contraindications to EIT monitoring (for example, implanted electrical cardiac devices and chest wall lesions obstructing the application of the EIT belt)

+Locations (1)

FacilityCityCountryStatus
St. Michael's HospitalToronto, OntarioCanada

+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. PMID 27836002
  • Longhini 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. PMID 31410738
  • Shi 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. PMID 40165223
  • Lemaire 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. PMID 3044189