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

NCT05630079 | Completed FDA Device

• 1 other identifier: FDG_05_17/02/2021
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Atelectasis; Acquired Brain Injury; Respiratory Rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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

  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

  15 days

Secondary Outcomes (2)

• Blood Gas Analysis

  15 days

• Peripheral Oxygen Saturation (SpO2) at night

  15 days

Study Arms (2)

Metaneb®

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®

IPV®

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®

Interventions

Treatment with Metaneb® DEVICE

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.

Metaneb®

Treatment with IPV® DEVICE

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.

IPV®

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 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

You may qualify if:

• Spontaneous breathing 24h/24h
• Presence of tracheostomy cannula
• Presence of atelectasis diagnosed through High Resolution Computed Tomography
• Levels of Cognitive Functioning (LCF) ≤ 5
• No pneumothorax
• Consent signed

You may not qualify if:

• Age under 18 years old

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Study Sites (1)

IRCCS Santa Maria Nascente, Fondazione Don Gnocchi

Milan, 20148, Italy

Location

MeSH Terms

Conditions

Pulmonary Atelectasis; Brain Injuries

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Pneumological Rehabilitation

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: November 29, 2022
• Study Start: February 22, 2021
• Primary Completion: July 31, 2021
• Study Completion: February 22, 2022
• Last Updated: November 29, 2022

Record last verified: 2022-11

Locations

IT (1)