RehabilitationNCT06453421
Pulmonary Rehabilitation in the Chronically Critically Ill Patient
An observational study of Rehabilitation and Chronic Critical Illness, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rehabilitation, Chronic Critical Illness
- What is being tested?
- Pulmonary rehabilitation
- How many people
- 220 participants
- Where
- 1 siteItaly
- Study dates
- 10 Feb 2023to 10 Aug 2029
- How long will I take part?
- 12 Months
- 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: Patients with respiratory failure who have undergone prolonged invasive mechanical ventilation via tracheostomy.
Who may be able to join
- age >18 years;
- episode of acute or acute-on-chronic respiratory failure with the need for prolonged invasive mechanical ventilation via tracheostomy
Who cannot join
- condition of clinical instability such as to make it necessary to transfer the patient to acute hospital within the first 7 days of hospitalization.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Fondazione Don Carlo Gnocchi ONLUS
Florence, 50143
Elisa Chellini, MD, echellini@dongnocchi.it
Chiara Fanciullacci, PhD, ctu@dongnocchi.it
About this study
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
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:
Read more
- 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.
Read the 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.
- Conditions
- Rehabilitation, Chronic Critical Illness
- Being tested
- Pulmonary rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary rehabilitationOther
Enrolled patients are subjected to a personalized respiratory rehabilitation treatment aimed both at weaning from the tracheostomy tube and at functional recovery
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients weaned from the tracheostomy tube
for each patient the presence of the tracheostomy tube and its possible removal are assessed
Measured: 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
for each patient the need for invasive mechanical ventilation and its possible removal are assessed
Measured: 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
evaluation of respiratory exchanges in terms mainly of oxygen blood pressure (mmHg) and of carbon dioxide blood pressure (mmHg).
Measured: 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 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
Measured: 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)
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
Measured: 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)
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.
Measured: 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)
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.
Measured: 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
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
Measured: 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
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.
Measured: 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)
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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)
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.
Measured: 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)
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).
Measured: 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
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).
Measured: 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)
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).
Measured: 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 .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start10 Feb 2023
- Primary completion31 Jan 2028 (estimated)
- Study completion10 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for RehabilitationStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 220 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisa Chellini, MD, Principal investigator, IRCCS Fondazione Don Carlo Gnocchi ONLUS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06453421
- Sponsor's protocol ID
- PCCinRR-SP2022
- Status last verified
- Feb 2025
- First submitted
- 14 May 2024
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
McCarthy B, Casey D, Devane D, Murphy K, Murphy E, Lacasse Y. Pulmonary rehabilitation for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2015 Feb 23;2015(2):CD003793. doi: 10.1002/14651858.CD003793.pub3.
PubMed 25705944Boles JM, Bion J, Connors A, Herridge M, Marsh B, Melot C, Pearl R, Silverman H, Stanchina M, Vieillard-Baron A, Welte T. Weaning from mechanical ventilation. Eur Respir J. 2007 May;29(5):1033-56. doi: 10.1183/09031936.00010206.
PubMed 17470624Garnacho-Montero J, Amaya-Villar R, Garcia-Garmendia JL, Madrazo-Osuna J, Ortiz-Leyba C. Effect of critical illness polyneuropathy on the withdrawal from mechanical ventilation and the length of stay in septic patients. Crit Care Med. 2005 Feb;33(2):349-54. doi: 10.1097/01.ccm.0000153521.41848.7e.
PubMed 15699838Laghi F, Cattapan SE, Jubran A, Parthasarathy S, Warshawsky P, Choi YS, Tobin MJ. Is weaning failure caused by low-frequency fatigue of the diaphragm? Am J Respir Crit Care Med. 2003 Jan 15;167(2):120-7. doi: 10.1164/rccm.200210-1246OC. Epub 2002 Oct 31.
PubMed 12411288Demoule A, Jung B, Prodanovic H, Molinari N, Chanques G, Coirault C, Matecki S, Duguet A, Similowski T, Jaber S. Diaphragm dysfunction on admission to the intensive care unit. Prevalence, risk factors, and prognostic impact-a prospective study. Am J Respir Crit Care Med. 2013 Jul 15;188(2):213-9. doi: 10.1164/rccm.201209-1668OC.
PubMed 23641946Jung B, Moury PH, Mahul M, de Jong A, Galia F, Prades A, Albaladejo P, Chanques G, Molinari N, Jaber S. Diaphragmatic dysfunction in patients with ICU-acquired weakness and its impact on extubation failure. Intensive Care Med. 2016 May;42(5):853-861. doi: 10.1007/s00134-015-4125-2. Epub 2015 Nov 16.
PubMed 26572511Jaber S, Petrof BJ, Jung B, Chanques G, Berthet JP, Rabuel C, Bouyabrine H, Courouble P, Koechlin-Ramonatxo C, Sebbane M, Similowski T, Scheuermann V, Mebazaa A, Capdevila X, Mornet D, Mercier J, Lacampagne A, Philips A, Matecki S. Rapidly progressive diaphragmatic weakness and injury during mechanical ventilation in humans. Am J Respir Crit Care Med. 2011 Feb 1;183(3):364-71. doi: 10.1164/rccm.201004-0670OC. Epub 2010 Sep 2.
PubMed 20813887Dres M, Dube BP, Mayaux J, Delemazure J, Reuter D, Brochard L, Similowski T, Demoule A. Coexistence and Impact of Limb Muscle and Diaphragm Weakness at Time of Liberation from Mechanical Ventilation in Medical Intensive Care Unit Patients. Am J Respir Crit Care Med. 2017 Jan 1;195(1):57-66. doi: 10.1164/rccm.201602-0367OC.
PubMed 27310484Epstein SK. Anatomy and physiology of tracheostomy. Respir Care. 2005 Apr;50(4):476-82.
PubMed 15807905Carson SS. Definitions and epidemiology of the chronically critically ill. Respir Care. 2012 Jun;57(6):848-56; discussion 856-8. doi: 10.4187/respcare.01736.
PubMed 22663962Carson SS, Bach PB. The epidemiology and costs of chronic critical illness. Crit Care Clin. 2002 Jul;18(3):461-76. doi: 10.1016/s0749-0704(02)00015-5.
PubMed 12140908Kahn JM, Benson NM, Appleby D, Carson SS, Iwashyna TJ. Long-term acute care hospital utilization after critical illness. JAMA. 2010 Jun 9;303(22):2253-9. doi: 10.1001/jama.2010.761.
PubMed 20530778Confalonieri M, Gorini M, Ambrosino N, Mollica C, Corrado A; Scientific Group on Respiratory Intensive Care of the Italian Association of Hospital Pneumonologists. Respiratory intensive care units in Italy: a national census and prospective cohort study. Thorax. 2001 May;56(5):373-8. doi: 10.1136/thorax.56.5.373.
PubMed 11312406Mifsud Bonnici D, Sanctuary T, Warren A, Murphy PB, Steier J, Marino P, Pattani H, Creagh-Brown BC, Hart N. Prospective observational cohort study of patients with weaning failure admitted to a specialist weaning, rehabilitation and home mechanical ventilation centre. BMJ Open. 2016 Mar 8;6(3):e010025. doi: 10.1136/bmjopen-2015-010025.
PubMed 26956162Hannan LM, Tan S, Hopkinson K, Marchingo E, Rautela L, Detering K, Berlowitz DJ, McDonald CF, Howard ME. Inpatient and long-term outcomes of individuals admitted for weaning from mechanical ventilation at a specialized ventilation weaning unit. Respirology. 2013 Jan;18(1):154-60. doi: 10.1111/j.1440-1843.2012.02266.x.
PubMed 22985330
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06453421
- Acronym / sponsor ID
- PCCinRR-SP2022
- Conditions
- Rehabilitation, Chronic Critical Illness
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- 10 Feb 2023 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 10 Aug 2029 (estimated)
- First posted
- 11 Jun 2024 (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 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chronic critical ill patients | – | Other: Pulmonary rehabilitationEvaluation 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with respiratory failure who have undergone prolonged invasive mechanical ventilation via tracheostomy.
Key inclusion criteria (2 listed)
- age >18 years;
- episode of acute or acute-on-chronic respiratory failure with the need for prolonged invasive mechanical ventilation via tracheostomy
Key exclusion criteria (1 listed)
- condition of clinical instability such as to make it necessary to transfer the patient to acute hospital within the first 7 days of hospitalization.
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 |
|---|---|---|
| Pulmonary rehabilitationEnrolled patients are subjected to a personalized respiratory rehabilitation treatment aimed both at weaning from the tracheostomy tube and at functional recovery | Other | chronic critical ill patients |
Primary outcome
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
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
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).
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
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
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.
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.
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
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.
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.
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.
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.
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.
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).
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).
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).
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 3 Mar 2025.
- Background: PubMed 25705944McCarthy B, Casey D, Devane D, Murphy K, Murphy E, Lacasse Y. Pulmonary rehabilitation for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2015 Feb 23;2015(2):CD003793. doi: 10.1002/14651858.CD003793.pub3.
- Background: PubMed 17470624Boles JM, Bion J, Connors A, Herridge M, Marsh B, Melot C, Pearl R, Silverman H, Stanchina M, Vieillard-Baron A, Welte T. Weaning from mechanical ventilation. Eur Respir J. 2007 May;29(5):1033-56. doi: 10.1183/09031936.00010206.
- Background: PubMed 15699838Garnacho-Montero J, Amaya-Villar R, Garcia-Garmendia JL, Madrazo-Osuna J, Ortiz-Leyba C. Effect of critical illness polyneuropathy on the withdrawal from mechanical ventilation and the length of stay in septic patients. Crit Care Med. 2005 Feb;33(2):349-54. doi: 10.1097/01.ccm.0000153521.41848.7e.
- Background: PubMed 12411288Laghi F, Cattapan SE, Jubran A, Parthasarathy S, Warshawsky P, Choi YS, Tobin MJ. Is weaning failure caused by low-frequency fatigue of the diaphragm? Am J Respir Crit Care Med. 2003 Jan 15;167(2):120-7. doi: 10.1164/rccm.200210-1246OC. Epub 2002 Oct 31.
- Background: PubMed 23641946Demoule A, Jung B, Prodanovic H, Molinari N, Chanques G, Coirault C, Matecki S, Duguet A, Similowski T, Jaber S. Diaphragm dysfunction on admission to the intensive care unit. Prevalence, risk factors, and prognostic impact-a prospective study. Am J Respir Crit Care Med. 2013 Jul 15;188(2):213-9. doi: 10.1164/rccm.201209-1668OC.
- Background: PubMed 26572511Jung B, Moury PH, Mahul M, de Jong A, Galia F, Prades A, Albaladejo P, Chanques G, Molinari N, Jaber S. Diaphragmatic dysfunction in patients with ICU-acquired weakness and its impact on extubation failure. Intensive Care Med. 2016 May;42(5):853-861. doi: 10.1007/s00134-015-4125-2. Epub 2015 Nov 16.
- Background: PubMed 20813887Jaber S, Petrof BJ, Jung B, Chanques G, Berthet JP, Rabuel C, Bouyabrine H, Courouble P, Koechlin-Ramonatxo C, Sebbane M, Similowski T, Scheuermann V, Mebazaa A, Capdevila X, Mornet D, Mercier J, Lacampagne A, Philips A, Matecki S. Rapidly progressive diaphragmatic weakness and injury during mechanical ventilation in humans. Am J Respir Crit Care Med. 2011 Feb 1;183(3):364-71. doi: 10.1164/rccm.201004-0670OC. Epub 2010 Sep 2.
- Background: PubMed 27310484Dres M, Dube BP, Mayaux J, Delemazure J, Reuter D, Brochard L, Similowski T, Demoule A. Coexistence and Impact of Limb Muscle and Diaphragm Weakness at Time of Liberation from Mechanical Ventilation in Medical Intensive Care Unit Patients. Am J Respir Crit Care Med. 2017 Jan 1;195(1):57-66. doi: 10.1164/rccm.201602-0367OC.
- Background: PubMed 15807905Epstein SK. Anatomy and physiology of tracheostomy. Respir Care. 2005 Apr;50(4):476-82.
- Background: PubMed 22663962Carson SS. Definitions and epidemiology of the chronically critically ill. Respir Care. 2012 Jun;57(6):848-56; discussion 856-8. doi: 10.4187/respcare.01736.
- Background: PubMed 12140908Carson SS, Bach PB. The epidemiology and costs of chronic critical illness. Crit Care Clin. 2002 Jul;18(3):461-76. doi: 10.1016/s0749-0704(02)00015-5.
- Background: PubMed 20530778Kahn JM, Benson NM, Appleby D, Carson SS, Iwashyna TJ. Long-term acute care hospital utilization after critical illness. JAMA. 2010 Jun 9;303(22):2253-9. doi: 10.1001/jama.2010.761.
- Individual participant dataSharing planned: Undecided
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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.
Elisa Chellini, MD principal investigator
IRCCS Fondazione Don Carlo Gnocchi ONLUS
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 Rehabilitation and Chronic Critical Illness, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
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 2 inclusion and 1 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 3 Mar 2025. 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 Italy. 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 Francesco Gigliotti, MD (+390557393913, fgigliotti@dongnocchi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 .). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06453421, which also lists 26 linked publications.
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 3 Mar 2025.