Mechanical Insufflation-Exsufflation in Critically Ill Patients
NCT07420946
Airway Clearance, Consensus
Naples, Italy
View Trial DetailsNCT Number: NCT07510776
Persistent Critical Illness (PCI) is a condition that affects some patients who remain in the Intensive Care Unit (ICU) for a long time, usually more than 10-14 days. It is estimated to occur in 5-20% of critically ill patients. A recent Portuguese study found that more than 14% of ICU patients stayed longer than 14 days. PCI is often associated with ongoing need for life support, such as mechanical ventilation or medications to maintain blood pressure. However, patients may also experience severe muscle weakness, repeated infections, or other complications, which makes this group very diverse.
One of the main risk factors for prolonged ICU stay is sepsis, a severe infection that affects the whole body. Other factors-such as prior health conditions, use of corticosteroids, sedation practices, early versus late mobilization, fluid and antibiotic management, and delirium treatment-may also influence the development and course of PCI.
This study aims to identify different clinical patterns ("clusters") among critically ill patients who remain in the ICU for more than 10 days. Patients will be followed until hospital discharge, and up to one year if data are available. Understanding these different patterns will help develop more personalized and effective care strategies for each patient profile.
The study is a multicenter retrospective cohort including adult patients (≥18 years) admitted to participating ICUs for more than 5 days between 2021 and 2023. Data collected will include demographic, clinical, and laboratory information, details of organ support (such as mechanical ventilation or vasopressors), medications, nutrition, and rehabilitation practices.
Statistical and machine learning methods will be used to identify groups of patients with similar clinical trajectories and to assess how these groups are related to outcomes such as survival, recovery of organ function, or long-term disability.
Expected results are the identification of distinct clinical clusters of PCI that combine clinical and laboratory data, and the development of tailored management strategies to improve recovery and outcomes for patients with PCI.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Centro Hospitalar de São João / ULS São João, Lisbon, Lisbon District, Portugal
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: The first 10 days in the ICU
Data from patients who remain in the ICU for more than 10 days requiring ongoing organ support, such as invasive mechanical ventilation, renal replacement therapy or vasopressors, will be used to identify those who develop Persistent Critical Illness and to enable subsequent cluster analysis of their clinical trajectories.
Time frame: From cluster identification (Day 10) until hospital discharge or up to 1-year follow-up if available.
Clinical outcomes will be assessed and reported according to clusters of Persistent Critical Illness (PCI) identified using unsupervised machine learning analysis at Day 10 of ICU stay. Outcome includes:
Time frame: From cluster identification (Day 10) until hospital discharge or up to 1-year follow-up if available.
Clinical outcomes will be assessed and reported according to clusters of Persistent Critical Illness (PCI) identified using unsupervised machine learning analysis at Day 10 of ICU stay. Outcome includes:
Time frame: Through ICU stay (up to 1 year).
Death occurring at any time during the ICU stay.
Time frame: Through hospital stay (up to 2 years).
Death occurring at any time during the hospital admission.
Time frame: Through ICU stay (up to 1 year).
Total number of calendar days from ICU admission to ICU discharge.
Time frame: Through ICU stay (up to 1 year).
Number of clinically or microbiologically documented infections acquired ≥48 hours after ICU admission.
Time frame: Through ICU stay (up to 1 year).
Longitudinal assessment of hemoglobin levels using repeated measurements obtained during the intensive care unit (ICU) stay.
Time frame: Through ICU stay (up to 1 year).
Longitudinal assessment of C-reactive protein levels using repeated measurements obtained during the intensive care unit stay.
Time frame: Through ICU stay (up to 1 year).
Longitudinal assessment of creatinine levels using repeated measurements obtained during the intensive care unit stay.
Time frame: Through ICU stay (up to 1 year).
Longitudinal assessment of albumin levels using repeated measurements obtained during the intensive care unit stay.
Time frame: Through ICU stay (up to 1 year).
Longitudinal assessment of lactate levels using repeated measurements obtained during the intensive care unit stay.
Contact information is provided by the study sponsor or research team.
Mariana Santos, PhD
CONTACT
Susana Fernandes, MD PhD.
CONTACT
Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboa
Network
Acronym: UPSt_UCI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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