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

Acquired Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05630079
• Other study ID #: FDG_05_17/02/2021
• Status: Completed
• Start date: February 22, 2021
• Est. completion date: February 22, 2022

Study information

• Verified date: November 2022
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 22, 2022
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Brain Injury
• Atelectasis
• Brain Injuries
• Pulmonary Atelectasis
• Respiratory Rehabilitation
• Wounds and Injuries

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	IRCCS Santa Maria Nascente, Fondazione Don Gnocchi	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Blood Gas Analysis	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	15 days
Secondary	Peripheral Oxygen Saturation (SpO2) at night	Average SpO2, Lowest SpO2, <90% (lenght of time SpO2 dropped below 90%), Average Heart Rate	15 days