An observational study in Pneumonia and Critical Illness, sponsored by Hospital H+ Queretaro. Recruiting at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Hospital H+ Queretaro · Observational
The goal of this observational study is to evaluate the safety and impact of a protocolized respiratory physiotherapy program on the dynamics of systemic inflammatory biomarkers (procalcitonin [PCT] and C-reactive protein [CRP]) in critically ill adult patients with pneumonia in the intensive care unit (ICU), compared with standard medical care.
The main questions it aims to answer are:
Does a protocolized respiratory physiotherapy program accelerate the decline of PCT and CRP levels in critically ill patients with pneumonia compared to standard care? What is the incidence and safety profile of adverse events (e.g., transient desaturation, hemodynamic instability, or mechanical displacement) associated with respiratory physiotherapy sessions?
Researchers will compare a prospective cohort receiving structured respiratory physiotherapy against a historical control group receiving standard care to determine changes in inflammatory trajectories and ICU length of stay. Participants in the prospective intervention group will:
2,076 studies on the registry are indexed under Pneumonia; 288 are open to participants now.
This study's planned enrollment of 180 is close to the median of 200 across 699 observational studies indexed under Pneumonia.
Browse Pneumonia studies →Hospital H+ Queretaro is the lead sponsor of 13 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Consecutive adult critically ill patients admitted to a tertiary care polyvalent Intensive Care Unit (ICU) with a confirmed diagnosis of severe pneumonia (community-acquired or nosocomial/ventilator-associated) requiring intensive management and an anticipated ICU stay of at least 48 hours. The study population consists of a prospective intervention cohort receiving protocolized respiratory physical therapy and a historical control cohort managed with standard medical care.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Adult patients admitted to the ICU with a confirmed diagnosis of pneumonia who receive an individualized, protocolized respiratory physiotherapy program (including high-frequency chest wall oscillation, intrapulmonary acoustic percussion, positive expiratory pressure, and inspiratory muscle training) alongside standard care.
Other: Protocolized Respiratory Physiotherapy Program
Retrospective historical cohort of adult patients admitted to the ICU with pneumonia who received standard medical, ventilatory, and nursing care without specialized protocolized respiratory physiotherapy.
Structured and dosed respiratory physical therapy regimen comprising high-frequency chest wall oscillation (HFCWO), intrapulmonary acoustic percussion, positive expiratory pressure (PEP), and inspiratory muscle training (IMT), aimed at optimizing pulmonary mechanics and clearing secretions.
Adjusted Change in Procalcitonin (PCT) Levels
Evaluates the adjusted change in serum procalcitonin levels from baseline across standardized time points (Day 3, Day 7, and ICU discharge) between the prospective intervention cohort and the historical control group using generalized linear mixed models (GLMM) with restricted cubic splines.
Time frame: Baseline, Day 3, Day 7, and up to ICU discharge (approx. 48 hours to length of stay)
Adjusted Change in C-Reactive Protein (CRP) Levels
Evaluates the adjusted change in serum C-reactive protein levels from baseline to subsequent time points during ICU stay.
Time frame: Baseline, Day 3, Day 7, and at ICU discharge (up to 30 days)
Intensive Care Unit (ICU) Length of Stay
Total duration of stay in the intensive care unit measured in days, analyzed jointly with inflammatory evolution.
Time frame: From ICU admission until ICU discharge or death (up to 30 days or hospital follow-up)
Incidence of Adverse Events Associated with Respiratory Physiotherapy
Absolute incidence, type, and frequency of acute adverse events (severe transient desaturation, hemodynamic instability/vasopressor increase, or mechanical displacement) occurring during or within 30 minutes post-intervention.
Time frame: During or within 30 minutes following each physiotherapy session (up to 30 days of ICU stay)
Started Sep 2026 (actual). Primary completion is estimated for Nov 2026, 2 months after the start.
Of 273 non-industry observational studies under Pneumonia, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 56. This study's planned 2 months is below that.
Counting every sponsor, half of 281 studies reached it within 25 months; a quarter within 14 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Hospital H+ Queretaro