## Protocol Section
### Identification Module
**NCT ID:** NCT05630079

**Brief Title:** Variation of Atelectasis Score After High-frequency Percussions in Severe Acquired Brain Injury

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

#### Organization Study ID Info
**ID:** FDG_05_17/02/2021
#### Organization
**Class:** OTHER
**Full Name:** Fondazione Don Carlo Gnocchi Onlus
### Status Module
#### Completion Date
**Date:** 2022-02-22

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-11-29

**Type:** ACTUAL

**Last Update Submit Date:** 2022-11-17

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2021-07-31

**Type:** ACTUAL

#### Start Date
**Date:** 2021-02-22

**Type:** ACTUAL

**Status Verified Date:** 2022-11

#### Study First Post Date
**Date:** 2022-11-29
**Type:** ACTUAL
**Study First Submit Date:** 2022-09-26
**Study First Submit QC Date:** 2022-11-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Fondazione Don Carlo Gnocchi Onlus

#### Responsible Party

**Investigator Affiliation:** Fondazione Don Carlo Gnocchi Onlus

**Investigator Full Name:** Paolo Banfi

**Investigator Title:** Head of Pneumological Rehabilitation

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** False

### Description Module

**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

**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 Module

**Conditions:**

- Atelectasis

- Acquired Brain Injury

- Respiratory Rehabilitation

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 15

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**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

**Intervention Names:**

- Device: Treatment with Metaneb®

**Label:** Metaneb®

#### Arm Group 2

**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

**Intervention Names:**

- Device: Treatment with IPV®

**Label:** IPV®

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Metaneb®

**Description:** 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.

**Name:** Treatment with Metaneb®

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- IPV®

**Description:** 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.

**Name:** Treatment with IPV®

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** 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

**Measure:** Variation of atelectasis score after treatment

**Time Frame:** 15 days

**Description:** Comparing the atelectasis score using an automatic score generated by Siemens (syngo.via CT Pneumonia Analysis), in case of discrepancy between all radiologists

**Measure:** Automatic score by Siemens

**Time Frame:** 15 days

#### Secondary Outcomes

**Description:** 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

**Measure:** Blood Gas Analysis

**Time Frame:** 15 days

**Description:** Average SpO2, Lowest SpO2, \<90% (lenght of time SpO2 dropped below 90%), Average Heart Rate

**Measure:** Peripheral Oxygen Saturation (SpO2) at night

**Time Frame:** 15 days

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Milano

**Country:** Italy

**Facility:** IRCCS Santa Maria Nascente, Fondazione Don Gnocchi

**Zip:** 20148

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000006259

- Term: Craniocerebral Trauma

- ID: D000020196

- Term: Trauma, Nervous System

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

### Condition Browse Module - Browse Leaves

- ID: M5207

- Name: Brain Injuries

- Relevance: HIGH

- As Found: Brain Injury

- ID: M4567

- Name: Pulmonary Atelectasis

- Relevance: HIGH

- As Found: Atelectasis

- ID: M17685

- Name: Wounds and Injuries

- Relevance: HIGH

- As Found: Injury

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9349

- Name: Craniocerebral Trauma

- Relevance: LOW

- As Found: Unknown

- ID: M22023

- Name: Trauma, Nervous System

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001261

- Term: Pulmonary Atelectasis

- ID: D000001930

- Term: Brain Injuries

- ID: D000014947

- Term: Wounds and Injuries

### Intervention Browse Module - Browse Branches

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Resp

- Name: Respiratory System Agents

### Intervention Browse Module - Browse Leaves

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

- ID: M21137

- Name: Respiratory System Agents

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
