Validation of the "ExSpiron©" in Patients With ALS

Validation of the "Exspiron©" in Patients With Amyotrophic Lateral Sclerosis; Non-invasive Monitoring of Respiratory Volume.

Non-invasive ventilation (NIV) in patients diagnosed with amyotrophic lateral sclerosis (ALS) is nowadays common practice to provide comfort at the end stage of the disease. As complaints vary there is the need of a non-invasive device to measure respiratory volume to objectify complaints.

The ExSpiron© is a device for non-invasive monitoring of respiratory volume. The validation of this monitor in patients with ALS is the aim of this study.

The hypothesis is that the ExSpiron© delivers a valid assessment of respiratory volume in patients with ALS

Study Overview

• Status: Not yet recruiting
• Conditions: Neuromuscular Diseases; Amyotrophic Lateral Sclerosis
• Intervention / Treatment: Device: ExSprion

Detailed Description

Rationale: Non-invasive ventilation (NIV) in patients diagnosed with amyotrophic lateral sclerosis (ALS) is nowadays common practice to provide comfort at the end stage of the disease. As complaints vary there is the need of a non-invasive device to measure respiratory volume to objectify complaints.

The ExSpiron© is a device for non-invasive monitoring of respiratory volume. The validation of this monitor in patients with ALS is the aim of this study.

The hypothesis is that the ExSpiron© delivers a valid assessment of respiratory volume in patients with ALS Objective: The primary objective is the validation of the ExSpiron© non-invasive monitor in patients diagnosed with ALS.

Study design: This is an intervention study The validation of the ExSpiron© in patients diagnosed with ALS is done during admission on the Respiratory Care Unit (RCU) of the University Medical Center Groningen (UMCG). At daytime, tidal volume (TV) and minute volume (MV) will be measured during spontaneous breathing with the ExSpiron© simultaneously with a pneumotachometer (gold-standard). After installation of the chest pad of the ExSpiron© and the pneumotachometer, the first measurements are in sitting position. Three complete cycles of ten breaths; normal breathing, slow-deep breathing and rapid-shallow breathing, will be done. Between each cycle, a pause is allowed. After completing this breathing sequence, it is repeated in supine position. If patients are not able to perform this in supine position, because of orthopnea, an angle of 45º degree is adequate. After completing this cycle, the chest pad should be left in place and the electromyography (EMG) equipment should be installed. During the first night of admission, a full night of measurement of TV and MV will be conducted using the ExSpiron©.

Study population: 10 patients diagnosed with ALS and an indication to start NIV, >18 years of age.

Intervention (if applicable): The ExSpiron© is a device for non-invasive monitoring of tidal volumes and minute ventilation in non-intubated patients by using a disposable chest pad.

Main study parameters/endpoints: The main endpoint is the validation of the ExSpiron© in patients diagnosed with ALS and screened positive for starting NIV.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: NIV has no known serious side effects. ALS patients differ in starting NIV is done on the RCU while patients are monitored as standard care, the ExSpiron© is not an extra risk complaints but those screened positive to start NIV are not associated with risks. The intervention product, ExSpiron© is a non-invasive monitor with a chest pad attached to the patient.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Peter Wijkstra, prof; Phone Number: +31 50 3613200; Email: p.j.wijsktra@umcg.nl
• Study Contact Backup: Name: Anda Hazenberg, dr; Phone Number: +31 50 3613200; Email: a.hazenberg@umcg.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

• Participants diagnosed with ALS requiring NIV
• Age > 18 of age; < 85 years of age
• An indication to start chronic NIV, hypercapnic respiratory failure (arterial carbon dioxide PaCO2 > 6.0 kilo pascal (kPa) measured during daytime) or orthopnoea due to diaphragm paralysis.
• Participants are able to provide feedback
• Participants that are willing to participate and are able to consent and sign the informed consent form.

Exclusion Criteria:

• A potential subject who meets any of the following criteria will be excluded from participation in this study:
• Clinically unstable
• Acute respiratory failure
• Participants with refractory hypotension, defined as systolic blood pressure less than 90 mmHg, despite inotropic agents
• Uncontrolled cardiac ischemia or arrhythmias
• Participants suffering from metastatic or terminal cancer
• Other comorbid disease affecting respiration (ie obstructive sleep apnea, chronic obstructive pulmonary disease)
• Participants lacking functional medical decision-making

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ExSpiron; 10 patients with ALS	Device: ExSprion; The primary objective is the validation of the ExSpiron© non-invasive monitor in patients diagnosed with ALS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The validity of the respiratory volumes (tidal volume and minute volume), compared tot the pneumotachometer.	The validation of the ExSpiron© non-invasive monitor in patients diagnosed with ALS.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The BORG RPE score (Ratings of Percieved Exertion)	Visual analogue scale (VAS) score from 0-10, 0 is worse outcome, 10 is best outcome	1 year
The Amyotrophic lateral Sclerosis Assessment Questionnaire (ALSAQ-40)	questionaire, score 0-4; 0 is never and 4 is always or can not do.	1 year
SenTec is the name of a transcutaneous monitor	Gas exchange during the night with the transcutaneous monitor SenTec©	1 year
The EMG	Respiratory muscle activity and patient-ventilator asynchrony during the night and during NIV assessed with surface electromyograph	1 year

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Investigators: Principal Investigator: Peter Wijkstra, prof, UMCG

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2025
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: September 6, 2019
• First Submitted That Met QC Criteria: September 12, 2019
• First Posted (Actual): September 13, 2019

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: ALS
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Sclerosis; Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Neuromuscular Diseases
• Other Study ID Numbers: UMCG

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No