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

Sponsor

Fondazione Don Carlo Gnocchi Onlus (Other)

Overall Status

Completed

CT.gov ID

NCT05630079

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Atelectasis Acquired Brain Injury Respiratory Rehabilitation	Device: Treatment with Metaneb® Device: Treatment with IPV®

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.

Study Design

Study Type:

Observational

Actual Enrollment :

15 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Feb 22, 2021

Actual Primary Completion Date :

Jul 31, 2021

Actual Study Completion Date :

Feb 22, 2022

Arms and Interventions

Arm	Intervention/Treatment
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® 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.
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® 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.

Arm

Intervention/Treatment

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®

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.

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®

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.

Outcome Measures

Primary Outcome Measures

Variation of atelectasis score after treatment [15 days]
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
Automatic score by Siemens [15 days]
Comparing the atelectasis score using an automatic score generated by Siemens (syngo.via CT Pneumonia Analysis), in case of discrepancy between all radiologists

Secondary Outcome Measures

Blood Gas Analysis [15 days]
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
Peripheral Oxygen Saturation (SpO2) at night [15 days]
Average SpO2, Lowest SpO2, <90% (lenght of time SpO2 dropped below 90%), Average Heart Rate

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IRCCS Santa Maria Nascente, Fondazione Don Gnocchi	Milano		Italy	20148

Sponsors and Collaborators

Fondazione Don Carlo Gnocchi Onlus

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Paolo Banfi, Head of Pneumological Rehabilitation, Fondazione Don Carlo Gnocchi Onlus

ClinicalTrials.gov Identifier:

NCT05630079

Other Study ID Numbers:

FDG_05_17/02/2021

First Posted:

Nov 29, 2022

Last Update Posted:

Nov 29, 2022

Last Verified:

Nov 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Pulmonary Atelectasis

Brain Injuries

Wounds and Injuries

Study Results

No Results Posted as of Nov 29, 2022