An observational study in Atelectasis, Acquired Brain Injury and Respiratory Rehabilitation, sponsored by Fondazione Don Carlo Gnocchi Onlus. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-29.
Sponsored by Fondazione Don Carlo Gnocchi Onlus · Observational
Investigators conduced in the Neurological Rehabilitation Unit of the IRCCS "S.Maria Nascente - Fondazione Don Gnocchi", (Milan) a retrospective study on 19 patients hospitalized between September 2018 and February 2021, with the aim of comparing the efficacy of the two devices, MetaNeb® and Intrapulmonary Percussion Ventilation (IPV®).
The efficacy was evaluated considering the change of various measures after two weeks of treatment. The main outcome considered is the atelectasis score, assigned by two radiologists who blindly and retrospectively evaluated it on high-resolution computed tomography (HRTC) images
Patients with severe acquired brain injury (sABI) frequently exhibit pulmonary complications, with atelectasis and/or consolidation of the lower lobes. The atelectasis in critically ill patients is a risk factor for pneumonia and increase the possibility to develop dysventilation syndrome with consequent negative impacts on gas exchanges.
To the best of our knowledge, there is no study investigating the use of the two devices for the treatment of atelectasis in the specific population of non-cooperative tracheostomized patients with sABI who had been spontaneously breathing with no mechanical ventilation support.
301 studies on the registry are indexed under Pulmonary Atelectasis; 80 are open to participants now.
This study's enrollment of 15 is below the median of 72 across 73 observational studies indexed under Pulmonary Atelectasis.
Browse Pulmonary Atelectasis studies →Fondazione Don Carlo Gnocchi Onlus is the lead sponsor of 146 studies on the registry; 37 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients admitted for severe acquired brain injury (sABI) in Neurological Rehabilitation Unit of IRCCS "Santa Maria Nascente - Fondazione Don Gnocchi" from September 2018 to February 2021
Exclusion Criteria:
Patients admitted for severe acquired brain injury (sABI) in Neurological Rehabilitation Unit of IRCCS "Santa Maria Nascente - Fondazione Don Gnocchi" received the MetaNeb® system treatment. It consist of simultaneous combination of positive pressure, continuous high frequency oscillations and aerosol delivery
Device: Treatment with Metaneb®
Patients with severe acquired brain injury from Neurological Rehabilitation Unit of IRCCS Fondazione Don Gnocchi, S.M. Nascente received the IPV® treatment. The principle of IPV® is to open collapsed airways and mobilize intrabronchial secretions through the delivery of small tidal volume at high frequency. IPV® adjusts the percussions to the changes in the mechanical properties of the patient's respiratory system: in case of high resistance, it produces small tidal volume at high pressure and low frequency; vice versa in case of low resistance, it produces large tidal volume at low pressure and high frequency
Device: Treatment with IPV®
Every patient of this group receive 3 daily treatments of 20 minutes each, performed at approximately 4-hour intervals. Each treatment with MetaNeb system consists of four cycles: : 5 minutes of Continuous Positive Expiratory Pressure (CPEP) for lung re-expansion (Cycle I), 5 minutes of Chest High Frequency Oscillation (CHFO) for secretion clearance (Cycle II), 5 min of CPEP (Cycle III), 5 minutes of CHFO (Cycle IV). Treatments are performed by respiratory physiotherapists and the pressure setted was the highest tolerated by the patient. It's associated with the administration of aerosols with 10 ml of saline solution 0.9% and are carried out by connecting the tracheostomy cannula cuffed to the catheter mount.
Each treatment with IPV provides 3 daily treatments of 20 minutes with the high percussion frequency tolerated by the patient. and I/E ratio: 1/1.2. Treatments are performed by respiratory physiotherapists and the pressure setted was the highest tolerated by the patient. It is associated with the administration of aerosols with 10 ml of saline solution 0.9% \[-\] and are carried out by connecting the tracheostomy cannula cuffed to the catheter mount.
Variation of atelectasis score after treatment
The aim is to compare the effect of the two devices, IPV® and MetaNeb® in the treatment of atelectasis. The atelectasis score is assigned by two radiologists who blindly and retrospectively evaluated it on high-resolution computed tomography (HRTC) images
Time frame: 15 days
Automatic score by Siemens
Comparing the atelectasis score using an automatic score generated by Siemens (syngo.via CT Pneumonia Analysis), in case of discrepancy between all radiologists
Time frame: 15 days
Blood Gas Analysis
Changes of respiratory parameters in terms of normalization of oxyemia (Arterial Pressure of oxygen 80-100 mmHg) and normalization of capnia (Arterial Pressure of carbon dioxide 35-45 mmHg), assessed by blood gas analysis
Time frame: 15 days
Peripheral Oxygen Saturation (SpO2) at night
Average SpO2, Lowest SpO2, \<90% (lenght of time SpO2 dropped below 90%), Average Heart Rate
Time frame: 15 days
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Fondazione Don Carlo Gnocchi Onlus