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Active, not recruitingNCT07901140Updated Oct 28, 2026

Adverse Events During Physical Therapy in Neurocritical ICU Patients

An observational study in Critical Illness, Brain Injury and Stroke, sponsored by Hospital H+ Queretaro. Active, not recruiting at 2 sites in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.

Primary conditionBrain InjuriesRegistry: Critical IllnessReclassifiedWhy we changed it
Registry
Critical Illness — the first condition term the registry derived for this study.
ClinicalTrials.gg
Brain Injuries
Why
  1. Critical Illness is a broad heading, used only when no more specific condition is named.
  2. The study's listed conditions name Brain Injuries.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Hospital H+ Queretaro · Observational

Updated Oct 28, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
47
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this observational study is to identify the clinical, neurological, hemodynamic, and respiratory variables associated with the occurrence of adverse events during physical therapy interventions in adult neurocritical patients admitted to the Intensive Care Unit (ICU).

The main questions it aims to answer are:

What clinical, neurological, hemodynamic, and respiratory factors are associated with adverse events during physical therapy in neurocritical patients? What is the incidence and type of adverse events that occur most frequently during physical therapy in this patient population? Researchers will compare clinical and physiological data between patients who experienced adverse events during physical therapy and those who did not, to determine risk factors associated with these complications. Participants' data will be retrospectively collected from medical records without performing new clinical interventions.

02

Conditions studied

  • Critical Illness
  • Brain Injury
  • Stroke
  • Subarachnoid Hemorrhage
  • Brain Neoplasms
  • Orthostatic Intolerance

Keywords

  • Early Mobilization
  • Neurocritical Care
  • Physical Therapy
  • Intensive Care Unit
  • Hemodynamic Stability
03

In context

Brain Injuries Reclassified

2,127 studies on the registry are indexed under Brain Injuries; 386 are open to participants now.

This study's planned enrollment of 47 is below the median of 100 across 692 observational studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

Hospital H+ Queretaro is the lead sponsor of 13 studies on the registry; 6 are open to participants now.

Compared within Brain Injuries, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Critical Illness. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Medical records of adult neurocritical patients admitted to the Intensive Care Unit (ICU) at a tertiary hospital in Querétaro, Mexico, who received physical therapy interventions between October 2023 and April 2026.

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.

Inclusion criteria

  • Adult patients (18 years or older) admitted to the Intensive Care Unit (ICU).
  • Patients classified with a neurocritical condition (e.g., ischemic or hemorrhagic stroke, brain tumor, aneurysm, traumatic brain injury, subarachnoid hemorrhage).
  • Complete medical records including documentation, notes, and charts from medical, nursing, and physical therapy departments.
  • Documented physical therapy intervention, vital signs monitoring, neurological scale scores, and pharmacological dosage records.

Exclusion criteria

Exclusion Criteria:

  • Medical records of adult patients admitted to general hospital wards or the emergency department.
  • Medical records of patients admitted to the Neonatal Intensive Care Unit (NICU).
  • Medical records of pregnant patients.
  • Medical records of patients not classified as neurocritical
  • Medical records of terminal patients or patients receiving palliative care with an estimated life expectancy of less than 24 hours at the time of ICU admission.
  • Medical records lacking documentation of physical therapy interventions.
  • Medical records lacking documentation of required hemodynamic and neurological values for risk analysis.
  • Medical records where collected data does not allow determining the presence or absence of adverse events during physical therapy.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
47 participants (estimated)
Patient registry
No

Groups and cohorts

  • Adverse Event Group

    Adult neurocritical ICU patients who presented at least one adverse event (e.g., hypotension, hypertension, tachycardia, bradycardia, oxygen desaturation, increased ICP, decreased CPP, acute neurological deterioration) during the physical therapy intervention.

    Other: Physical Therapy Intervention

  • No Adverse Event Group

    Adult neurocritical ICU patients who underwent physical therapy intervention without experiencing any adverse events during the session.

    Other: Physical Therapy Intervention

Interventions

  • OtherPhysical Therapy Intervention

    Physical therapy and mobilization procedures administered to neurocritical patients during their ICU stay as recorded in medical, nursing, and physical therapy notes. Retrospective data collection evaluates baseline clinical-pathological risk profile and monitoring parameters (hemodynamics, neurological, respiratory).

06

What researchers measure

Primary outcomes

  1. Incidence of Adverse Events During Physical Therapy

    Presence or absence of any adverse event (binary variable: Yes/No) occurring during or immediately following a physical therapy session in adult neurocritical ICU patients. Adverse events include: hypotension (drop in SBP \> 20 mmHg), hypertension, tachycardia, bradycardia, oxygen desaturation, acute neurological deterioration, increase in intracranial pressure (ICP), or decrease in cerebral perfusion pressure (CPP) requiring therapy session suspension.

    Time frame: During the physical therapy session (from initiation up to immediate post-session evaluation, up to 1 hour per session).

Secondary outcomes

  1. Clinical and Physiological Predictors of Adverse Events

    Association between baseline clinical-pathological variables and the occurrence of adverse events during physical therapy. Evaluated parameters include: Glasgow Coma Scale (GCS), Mean Arterial Pressure (MAP), Richmond Agitation-Sedation Scale (RASS), vasopressor dependence, SpO2/FiO2 ratio (SAFI), external ventricular drain presence, and decompressive procedure history.

    Time frame: Baseline assessment immediately prior to each physical therapy session.

  2. Frequency and Specific Types of Adverse Events

    Distribution and frequency of specific types of adverse events recorded during therapy sessions, categorized into hemodynamic (hypotension, hypertension, tachycardia, bradycardia), respiratory (oxygen desaturation), and neurological (acute deterioration, ICP increase, CPP decrease).

    Time frame: During each physical therapy session throughout the ICU stay (retrospectively evaluated from October 2023 to April 2026).

  3. Comparative Analysis of Hemodynamic versus Respiratory Variables

    Statistical comparison using Student's t-test to evaluate whether hemodynamic variables show significantly higher association with adverse events compared to respiratory variables.

    Time frame: Retrospective evaluation spanning the total ICU stay for each patient record (October 2023 to April 2026).

07

Study locations

2 sites
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2026 (actual). Primary completion is estimated for Oct 2026, 1 month after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 21, 2026
First posted
Oct 28, 2026
StartActual
Sep 23, 2026
Primary completionEst.
Oct 31, 2026
CompletionEst.
Oct 31, 2026
Last update
Oct 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 28, 2026
Show all 1 update
  1. Oct 28, 2026
    First appeared on the registry

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 ↗

09

Registry details

Key details

Study ID
NCT07901140
Lead sponsor
Hospital H+ Queretaro
Responsible party
Jose J Zaragoza, MD MSc (Principal Investigator, Hospital H+ Queretaro) — Principal investigator
First posted
Oct 28, 2026
Start date
Sep 23, 2026
Primary completion
Oct 31, 2026 (estimated)
Completion
Oct 31, 2026 (estimated)
Last update
Oct 28, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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