Pulmonary Rehabilitation in the Chronically Critically Ill Patient

February 27, 2025 updated by: Fondazione Don Carlo Gnocchi Onlus

Pulmonary Rehabilitation in the Chronically Critically Ill Patient: Prospective Study About Clinical Characteristics and the Response to Rehabilitation in This Patient Population and Search for Potential Predictive Factors

The goal of this observational study is to learn about the population of chronically critical ill patients who refer to respiratory rehabilitation units.

The main questions it aims to answer are:

  • what are the clinical and pathophysiological characteristics of the population of chronically critical ill patients who refer to respiratory rehabilitation units after hospital admission with the need for prolonged invasive mechanical ventilation via tracheostomy?
  • what is the response of this patient population to respiratory rehabilitation treatment in terms of functional recovery, weaning from invasive mechanical ventilation, weaning from tracheostomy tube, mortality and return to home?
  • are there any appreciable indices at admission and/or in the first period of hospitalization which may have a prognostic significance both on short-term objectives (weaning from invasive mechanical ventilation, weaning from the tracheostomy tube) and in the medium-long term (survival, state of health)?

Participants will be subjected to a rehabilitation and weaning program consisting of:

  • physical therapy,
  • speech therapy,
  • nutritional assessment and therapy,
  • in subjects on invasive mechanical ventilation at admission a program of weaning and, if needed, shift from invasive to Non-Invasive Ventilation will be performed.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Observational, prospective, non-profit study. The first aim is to define the clinical and pathophysiological characteristics of the population of chronic critically ill patients who refer to respiratory rehabilitation units after hospital admission with the need for prolonged invasive mechanical ventilation via tracheostomy.

The second aim is to identify the following aspects: evaluating the response of this particular patient population to respiratory rehabilitation treatment (functional recovery, weaning from invasive mechanical ventilation, decannulation and home discharge), knowing the mortality of this patient population and evaluating the existence of appreciable indices at admission and/or in the first period of hospitalization which may have a prognostic significance both on short-term objectives (weaning from invasive mechanical ventilation, weaning from the tracheostomy tube) and in the medium-long term (survival, state of health). This last aspect could also be useful for the early identification of patients who could benefit from rehabilitation treatment more than others and therefore to optimize the resources at our disposal.

The present study involves the collection of data from chronically critical patients who will be referred to the Rehabilitation Pneumology Unit of the Don Gnocchi Foundation in Florence after hospitalization in intensive care for respiratory failure with the need for prolonged invasive mechanical ventilation.

The prospective analysis will have a total duration of 6 months.

The enrolled patients will follow the standard care path provided by the center and in this context they will carry out the rehabilitation treatment both within the department and in the dedicated respiratory gym.

The variables of interest will be extracted from the medical records at the time of entry (T0) to the department and at the time of discharge (T1).

It is expected to enroll 220 patients under ordinary hospitalization at the unit of Rehabilitative Pneumology of the Don Gnocchi Foundation of Florence.

The default sample size was set based on the recruiting capacity of the center involved in the project.

The data will be retrieved from the medical records of patients belonging to the department.

The folders will be viewed by the main investigator and his collaborators and the data of interest and the reports of the instrumental tests will be extracted.

Starting from the clinical and anamnestic evaluation upon admission to the department, patients who fall within the inclusion criteria will be identified.

The data will be entered anonymously into a computerized database, in which each subject will be associated with an alphanumeric identification code. The correspondence between the patients' name and numerical identity (progressive enrollment number) will be recorded in a separate table (association key) kept by the principal investigator.

The paper data relating to the study will be stored in an archive accessible only to the Principal Investigator, while the electronic data will be stored on servers located in the territory of the European Union on physical archives protected by double key encryption systems.

During the duration of the study, access to the computerized and anonymized database will be limited to the principal investigator, who may extend access to identified collaborators. The anonymized data will be retained for a period of 7 years after the conclusion of the study. Once the retention period indicated above has expired, the data will be made anonymous so that it is no longer possible to trace, directly or indirectly, the identity of the interested party. The anonymized data may be reused for subsequent research and therefore stored by the joint owners indefinitely.

For the analysis of the primary objective, a descriptive statistic will be used through which the clinical and clinical-functional variables recorded at admission (T0) will be presented. In particular, for continuous variables (or similar to such, e.g. age, Barthel score) mean and standard deviation or median and interquartile range will be used, depending on whether the variables have a normal distribution or not, as descriptors respectively of central tendency and dispersion. The normality or otherwise of the distribution of each variable will be verified by evaluating the asymmetry and kurtosis parameters of the distribution itself. As regards dichotomous variables (e.g. presence of infections), the frequency values in the observed sample and the relative percentages will be reported.

For the analysis of the first secondary objective, a comparison will be made between the values recorded at T0 and at discharge (T1) for the clinical and clinical-functional variables that require a reassessment at T1. The comparison will be carried out using a T-test for paired measures or a Wilcoxon Signed-Rank Test in the case of continuous variables, depending on whether or not they have an approximately normal distribution. In the case of categorical/ordinal variables, the Wilcoxon Signed-Rank Test will be used and the McNemar's test in the case of dichotomous variables. For all tests a p-value<0.05 will be considered significant.

For the analysis of the second and third secondary objectives, logistic regression models will be used to evaluate the association between the independent variables (variables recorded at admission and their changes in the first weeks) and the dependent variables (weaning from invasive mechanical ventilation, weaning from tracheostomy tube, survival and health status).

Furthermore, the changes in parameters measured at admission and at discharge will be compared through repeated measures analyses. In particular, for continuous variables, a repeated measures ANOVA test or a Friedman test will be used, depending on whether the variables have a normal distribution or not. For dichotomous variables, a Cochran's Q test will be used. For all tests, a p-value<0.05 will be considered significant.

Study Type

Observational

Enrollment (Estimated)

220

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with respiratory failure who have undergone prolonged invasive mechanical ventilation via tracheostomy.

Description

Inclusion Criteria:

  • age >18 years;
  • episode of acute or acute-on-chronic respiratory failure with the need for prolonged invasive mechanical ventilation via tracheostomy

Exclusion Criteria:

condition of clinical instability such as to make it necessary to transfer the patient to acute hospital within the first 7 days of hospitalization.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
chronic critical ill patients
Evaluation both of the clinical and pathophysiological characteristics of a group of chronically critical ill patients admitted to a pulmonary rehabilitation center and of their response to rehabilitation treatment
Other: Pulmonary rehabilitation
Enrolled patients are subjected to a personalized respiratory rehabilitation treatment aimed both at weaning from the tracheostomy tube and at functional recovery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
functional independence measure (FIM) scale
Time Frame: From date of randomization until the date of discharge or date of hospitalization or death from any cause, whichever came first, assessed up to 1 year .
An international standard for measuring disability, with a score from 18 to 126 where higher values correspond to a greater level of autonomy
From date of randomization until the date of discharge or date of hospitalization or death from any cause, whichever came first, assessed up to 1 year .
Modified barthel index (mBI)
Time Frame: From date of randomization until the date of discharge or date of hospitalization or death from any cause, whichever came first, assessed up to 1 year .
An ordinal scale used to measure a subject's performance in Activities of Daily Living (ADL), with a score from 0 to 100 where higher values correspond to a greater level of autonomy
From date of randomization until the date of discharge or date of hospitalization or death from any cause, whichever came first, assessed up to 1 year .
Short Physical Performance Battery (SPPB)
Time Frame: From date of randomization until the date of discharge or date of hospitalization or death from any cause, whichever came first, assessed up to 1 year .
A group of measures that combines the results of the gait speed, chair stand and balance tests. It can be useful as a predictive tool for possible disability and can aid in the monitoring of function. With a score from 0 to 12 where higher values correspond to a better motor function.
From date of randomization until the date of discharge or date of hospitalization or death from any cause, whichever came first, assessed up to 1 year .
Short Form 12 (SF12)
Time Frame: From date of randomization until the date of discharge or date of hospitalization or death from any cause, whichever came first, assessed up to 1 year .
A self-reported measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure, with a score from 12 to 47 where lower values correspond to a better quality of life.
From date of randomization until the date of discharge or date of hospitalization or death from any cause, whichever came first, assessed up to 1 year .
Pain evaluation
Time Frame: From date of randomization until the date of discharge or date of hospitalization or death from any cause, whichever came first, assessed up to 1 year .
Intensity of the pain is assessed through the visual analogue scale (VAS). A 10 cm long visual scale where the length corresponds directly to the pain
From date of randomization until the date of discharge or date of hospitalization or death from any cause, whichever came first, assessed up to 1 year .
Barthel dyspnea
Time Frame: From date of randomization until the date of discharge or date of hospitalization or death from any cause, whichever came first, assessed up to 1 year .
An ordinal scale used to measure a subject's level of dyspnea while performing Activities of Daily Living (ADL), with a score from 0 to 100 where lower values correspond to a greater level of dyspnea.
From date of randomization until the date of discharge or date of hospitalization or death from any cause, whichever came first, assessed up to 1 year .
Hospital Anxiety and Depression Scale (HADS)
Time Frame: From date of randomization until the date of discharge or date of hospitalization or death from any cause, whichever came first, assessed up to 1 year .
A self-reported measure, made up of 14 items, 7 for the evaluation of anxiety and 7 for depression. For both anxiety and depression the score ranges from 0 to 21. The higher scores correspond to a greater probability of being affected by the pathology.
From date of randomization until the date of discharge or date of hospitalization or death from any cause, whichever came first, assessed up to 1 year .
Malnutrition Universal Screening Tool (MUST) scale
Time Frame: From date of randomization until the date of discharge or date of hospitalization or death from any cause, whichever came first, assessed up to 1 year .
A screening tool to identify malnourished adults, at risk of malnutrition (undernutrition) or obesity. It has a score ranging from 0 to 6. The lower score corresponds to a lower risk of malnutrition.
From date of randomization until the date of discharge or date of hospitalization or death from any cause, whichever came first, assessed up to 1 year .
Montreal Cognitive Assessment (MoCA)
Time Frame: From date of randomization until the date of discharge or date of hospitalization or death from any cause, whichever came first, assessed up to 1 year .
The MoCA is a tool for rapid screening of mild cognitive impairment. It evaluates different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructive skills, abstraction, calculation and orientation. The maximum possible score is 30 points; an equal score or above 26 is considered normal.
From date of randomization until the date of discharge or date of hospitalization or death from any cause, whichever came first, assessed up to 1 year .
Functional Oral Intake Scale (FOIS)
Time Frame: From date of randomization until the date of discharge or date of hospitalization or death from any cause, whichever came first, assessed up to 1 year .
A tool to assess functional oral intake of food and liquids in patients with oropharyngeal dysphagia. The score ranges from 1 (no oral intake) to 7 (total oral intake with no restrictions).
From date of randomization until the date of discharge or date of hospitalization or death from any cause, whichever came first, assessed up to 1 year .
Medical Research Council (MRC) Scale
Time Frame: From date of randomization until the date of discharge or date of hospitalization or death from any cause, whichever came first, assessed up to 1 year .
The MRC Scale is a scale of 6 values, ranging from 0 to 5, for measuring strength through the observation of muscle movements and behavior for grades from 0 to 3, and the administration of manual muscle tests for grades 4 and 5. It consists of a strength attribution score, ranging from 0 (absence of contraction) to 5 (normal strength).
From date of randomization until the date of discharge or date of hospitalization or death from any cause, whichever came first, assessed up to 1 year .
Modified Rankin Scale (MRS)
Time Frame: From date of randomization until the date of discharge or date of hospitalization or death from any cause, whichever came first, assessed up to 1 year .
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of patients. The scale runs from 0-6, running from perfect health without symptoms (0) to death (6).
From date of randomization until the date of discharge or date of hospitalization or death from any cause, whichever came first, assessed up to 1 year .
Number of patients weaned from the tracheostomy tube
Time Frame: From date of randomization until the date of discharge or date of hospitalization or death from any cause, whichever came first, assessed up to 1 year .
for each patient the presence of the tracheostomy tube and its possible removal are assessed
From date of randomization until the date of discharge or date of hospitalization or death from any cause, whichever came first, assessed up to 1 year .
Number of patients weaned from invasive mechanical ventilation
Time Frame: From date of randomization until the date of discharge or date of hospitalization or death from any cause, whichever came first, assessed up to 1 year .
for each patient the need for invasive mechanical ventilation and its possible removal are assessed
From date of randomization until the date of discharge or date of hospitalization or death from any cause, whichever came first, assessed up to 1 year .
arterial blood gas analysis
Time Frame: From date of randomization until the date of discharge or date of hospitalization or death from any cause, whichever came first, assessed up to 1 year .
evaluation of respiratory exchanges in terms mainly of oxygen blood pressure (mmHg) and of carbon dioxide blood pressure (mmHg).
From date of randomization until the date of discharge or date of hospitalization or death from any cause, whichever came first, assessed up to 1 year .
Change in nutritional status from admission to discharge
Time Frame: From date of randomization until the date of discharge or date of hospitalization or death from any cause, whichever came first, assessed up to 1 year .
Global Leadership Initiative on Malnutrition (GLIM) criteria are 5 diagnostic criteria to assess malnutrition that include 3 phenotypic (weight loss, low body mass index and reduced muscle mass) and 2 etiologic (reduced food intake/assimilation, and inflammation /disease burden) criteria. To diagnose malnutrition at least 1 phenotypic criterion and 1 etiologic criterion should be present.
From date of randomization until the date of discharge or date of hospitalization or death from any cause, whichever came first, assessed up to 1 year .

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Don Carlo Gnocchi Onlus

Investigators

  • Principal Investigator: Elisa Chellini, MD, IRCCS Fondazione Don Carlo Gnocchi ONLUS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2023

Primary Completion (Estimated)

January 31, 2028

Study Completion (Estimated)

August 10, 2029

Study Registration Dates

First Submitted

May 14, 2024

First Submitted That Met QC Criteria

June 5, 2024

First Posted (Actual)

June 11, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 27, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCCinRR-SP2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rehabilitation

Clinical Trials on Pulmonary rehabilitation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Chile

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe