Pulmonary Rehabilitation in the Chronically Critically Ill Patient

NCT06453421 | Recruiting

• 1 other identifier: PCCinRR-SP2022
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rehabilitation; Chronic Critical Illness

Outcome Measures

Primary Outcomes (16)

• Number of patients weaned from the 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 .

• Number of patients weaned from 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 .

• arterial blood gas analysis

  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 .

• 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 .

• 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 .

• 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 .

• 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 .

• 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 .

• 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 .

• 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 .

• 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 .

• 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.

  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.

  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).

  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).

  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).

  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 .

Study Arms (1)

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

Interventions

Pulmonary rehabilitation OTHER

Enrolled patients are subjected to a personalized respiratory rehabilitation treatment aimed both at weaning from the tracheostomy tube and at functional recovery

chronic critical ill patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Study Sites (1)

IRCCS Fondazione Don Carlo Gnocchi ONLUS

Florence, 50143, Italy

RECRUITING

Related Publications (26)

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Study Officials

• Elisa Chellini, MD

  IRCCS Fondazione Don Carlo Gnocchi ONLUS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Gigliotti, MD

CONTACT

+390557393913; fgigliotti@dongnocchi.it

Elisa Chellini, MD

CONTACT

+390557393914; echellini@dongnocchi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: June 11, 2024
• Study Start: February 10, 2023
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): August 10, 2029
• Last Updated: March 3, 2025

Record last verified: 2025-02

Locations

IT (1)