PneumoniaNCT07909616
Respiratory Physiotherapy and Inflammatory Biomarkers in Critically Ill Patients With Pneumonia
An observational study of Pneumonia and Critical Illness, run by Hospital H+ Queretaro at 1 site in Mexico.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Critical Illness
- What is being tested?
- Protocolized Respiratory Physiotherapy Program
- How many people
- 180 participants
- Where
- 1 siteMexico
- Study dates
- 8 Sep 2026to 1 Dec 2026
- 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
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Consecutive adult patients (age >= 18 years at the time of admission).
- Confirmed diagnosis of pneumonia (community-acquired, hospital-acquired, or ventilator-associated pneumonia) as the primary cause of ICU admission or critical complication.
- Anticipated or actual ICU length of stay >= 48 hours.
Who cannot join
- Presence of limitation of medical treatment orders or exclusively palliative management upon admission.
- Concomitant severe non-infectious systemic inflammatory diseases that massively alter or mask procalcitonin response (e.g., severe acute pancreatitis, extensive burns).
- Refractory hemodynamic instability or uncontrolled septic shock with escalating vasopressor requirements that contraindicate physical manipulation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Hospital H+ Querétaro, Santiago de Querétaro, Querétaro
Querétaro
LAURA RAQUEL TREVIÑO ROCHA, 442 111 7104 ext. +52, lauratvrocha@gmail.com
About this study
Official title: Dynamics of Procalcitonin and C-Reactive Protein Associated With Respiratory Physiotherapy in Critically Ill Patients With Pneumonia
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:
Read more
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:
- Receive an individualized, protocolized respiratory physiotherapy regimen (including high-frequency chest wall oscillation [HFCWO], intrapulmonary acoustic percussion, positive expiratory pressure [PEP], and/or inspiratory muscle training [IMT]) tailored to their clinical deficits.
- Undergo continuous safety monitoring during and up to 30 minutes following each physiotherapy session.
- Have serum PCT and CRP levels measured at baseline (T0), Day 3 (T1), Day 7 (T2), and at ICU discharge (T3).
- Conditions
- Pneumonia, Critical Illness
- Being tested
- Protocolized Respiratory Physiotherapy Program
- Keywords
- Respiratory Physiotherapy, Procalcitonin, C-Reactive Protein, Intensive Care Unit, Inflammatory Biomarkers
- Medical subject headings
- Pneumonia, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protocolized Respiratory Physiotherapy ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Prospective Intervention Group | 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. Receives: Other: Protocolized Respiratory Physiotherapy Program | |
| Historical Control Group | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Day 3, Day 7, and up to ICU discharge (approx. 48 hours to length of stay)
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: During or within 30 minutes following each physiotherapy session (up to 30 days of ICU stay)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start8 Sep 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies 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
- Other
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital H+ Queretaro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose J Zaragoza, MD MSc, Hospital H+ Queretaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07909616
- Sponsor's protocol ID
- CEI2026-10/01/V1
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamics of Procalcitonin and C-Reactive Protein Associated With Respiratory Physiotherapy in Critically Ill Patients With Pneumonia
- ClinicalTrials.gov ID
- NCT07909616
- Acronym / sponsor ID
- CEI2026-10/01/V1
- Conditions
- Pneumonia, Critical Illness
- Keywords
- Respiratory Physiotherapy, Procalcitonin, C-Reactive Protein, Intensive Care Unit, Inflammatory Biomarkers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Hospital H+ QueretaroUniversity, hospital or other
- Study start
- 8 Sep 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 2 Nov 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.
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:
- Receive an individualized, protocolized respiratory physiotherapy regimen (including high-frequency chest wall oscillation [HFCWO], intrapulmonary acoustic percussion, positive expiratory pressure [PEP], and/or inspiratory muscle training [IMT]) tailored to their clinical deficits.
- Undergo continuous safety monitoring during and up to 30 minutes following each physiotherapy session.
- Have serum PCT and CRP levels measured at baseline (T0), Day 3 (T1), Day 7 (T2), and at ICU discharge (T3).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective Intervention Group | – | Other: Protocolized Respiratory Physiotherapy ProgramAdult 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. |
| Historical Control Group | – | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- Consecutive adult patients (age >= 18 years at the time of admission).
- Confirmed diagnosis of pneumonia (community-acquired, hospital-acquired, or ventilator-associated pneumonia) as the primary cause of ICU admission or critical complication.
- Anticipated or actual ICU length of stay >= 48 hours.
Key exclusion criteria (3 listed)
- Presence of limitation of medical treatment orders or exclusively palliative management upon admission.
- Concomitant severe non-infectious systemic inflammatory diseases that massively alter or mask procalcitonin response (e.g., severe acute pancreatitis, extensive burns).
- Refractory hemodynamic instability or uncontrolled septic shock with escalating vasopressor requirements that contraindicate physical manipulation.
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 |
|---|---|---|
| Protocolized Respiratory Physiotherapy ProgramStructured 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. | Other | Prospective Intervention Group |
Primary outcome
Adjusted Change in Procalcitonin (PCT) Levels
Time frame: Baseline, Day 3, Day 7, and up to ICU discharge (approx. 48 hours to length of stay)
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.
3 secondary outcomes
Adjusted Change in C-Reactive Protein (CRP) Levels
Time frame: Baseline, Day 3, Day 7, and at ICU discharge (up to 30 days)
Intensive Care Unit (ICU) Length of Stay
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
Time frame: During or within 30 minutes following each physiotherapy session (up to 30 days of ICU stay)
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 2 Nov 2026.
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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 Pneumonia and Critical Illness, run by Hospital H+ Queretaro at 1 site in Mexico.
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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 2 Nov 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 Mexico. 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 LAURA RAQUEL TREVIÑO ROCHA (442 111 7104 ext. +52, lauratvrocha@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adjusted Change in Procalcitonin (PCT) Levels (time frame: Baseline, Day 3, Day 7, and up to ICU discharge (approx. 48 hours to length of stay)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2026.