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

D

Don Carlo Gnocchi Onlus Foundation

Status

Completed

Conditions

Respiratory Rehabilitation
Atelectasis
Acquired Brain Injury

Treatments

Device: Treatment with IPV®
Device: Treatment with Metaneb®

Study type

Observational

Funder types

Other

Identifiers

NCT05630079
FDG_05_17/02/2021

Details and patient eligibility

About

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

Full 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.

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • Age under 18 years old

Trial design

15 participants in 2 patient groups

Metaneb®
Description:
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
Treatment:
Device: Treatment with Metaneb®
IPV®
Description:
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
Treatment:
Device: Treatment with IPV®

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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