Pulmonary Rehabilitation in the Chronically Critically Ill Patient
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Don Carlo Gnocchi Onlus
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age >18 years;
episode of acute or acute-on-chronic respiratory failure with the need for prolonged invasive mechanical ventilation via tracheostomy
Disqualifiers
None
Trial population
Patients with respiratory failure who have undergone prolonged invasive mechanical ventilation via tracheostomy.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Pulmonary rehabilitation
Other interventionEnrolled patients are subjected to a personalized respiratory rehabilitation treatment aimed both at weaning from the tracheostomy tube and at functional recovery
Treatment groups
220 Participants
are divided into 1 treatment groupGroup A: chronic critical ill patients1 intervention
Trial outcomes
Primary outcomes
1
Number of patients weaned from the tracheostomy tube
for each patient the presence of the tracheostomy tube and its possible removal are assessed
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 .2
Number of patients weaned from invasive mechanical ventilation
for each patient the need for invasive mechanical ventilation and its possible removal are assessed
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 .3
arterial blood gas analysis
evaluation of respiratory exchanges in terms mainly of oxygen blood pressure (mmHg) and of carbon dioxide blood pressure (mmHg).
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 .4
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
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 .Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov