NCT05630079

Variation of Atelectasis Score After High-frequency Percussions in Severe Acquired Brain Injury

Short-term Variation of Atelectasis Score After High-frequency Percussions in Patients With Severe Acquired Brain Injury: a Retrospective Cohort Study.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 15 (actual)
• Sponsor: Fondazione Don Carlo Gnocchi Onlus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Atelectasis
• Acquired Brain Injury
• Respiratory Rehabilitation

Interventions

Type	Name	Description
DEVICE	Treatment with Metaneb®	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.
DEVICE	Treatment with IPV®	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.

Timeline

• Start date: 2021-02-22
• Primary completion: 2021-07-31
• Completion: 2022-02-22
• First posted: 2022-11-29
• Last updated: 2022-11-29

Locations

1 site across 1 country: Italy

Regulatory

• FDA-regulated device study