Pulmonary Rehabilitation in the Chronically Critically Ill Patient

Rehabilitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06453421
• Other study ID #: PCCinRR-SP2022
• Status: Recruiting
• Start date: February 10, 2023
• Est. completion date: August 10, 2029

Study information

• Verified date: January 2024
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: Francesco Gigliotti, MD
• Phone: +390557393913
• Email: fgigliotti[@]dongnocchi.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: August 10, 2029
• Est. primary completion date: January 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Critical Illness
• Critical Illness
• Rehabilitation

Intervention

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

Locations

Country	Name	City	State
Italy	IRCCS Fondazione Don Carlo Gnocchi ONLUS	Florence

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus

Country where clinical trial is conducted

Italy, 

References & Publications (26)

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* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Need for tracheostomy tube	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 .
Primary	Need for invasive mechanical ventilation	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 .
Primary	arterial blood gas analysis	evaluation of respiratory exchanges in terms mainly of oxygen blood pressure and of carbon dioxide blood pressure.	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 .
Primary	functional independence measure (FIM) scale	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 .
Primary	Modified barthel index (mBI)	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 .
Primary	Short Physical Performance Battery (SPPB)	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 .
Primary	Short Form 12 (SF12)	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 .
Primary	Pain evaluation	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 .
Primary	Barthel dyspnea	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 .
Primary	Hospital Anxiety and Depression Scale (HADS)	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 .
Primary	Malnutrition Universal Screening Tool (MUST) scale	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 .
Primary	Global Leadership Initiative on Malnutrition (GLIM) evaluation	A consensus scheme for the diagnosis of malnutrition in adult patients in a clinical setting. It consists of a risk screening, followed by a diagnostic evaluation based on both phenotypic and etiological criteria. Finally, it allows the evaluation of the severity of malnutrition based on phenotypic criteria.	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 .
Primary	Montreal Cognitive Assessment (MoCA)	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 .
Primary	Functional Oral Intake Scale (FOIS)	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 .
Primary	Medical Research Council (MRC) Scale	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 .
Primary	Modified Rankin Scale (MRS)	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 .