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Validation of the "ExSpiron©" in Patients With ALS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04089696
Recruitment Status : Not yet recruiting
First Posted : September 13, 2019
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
Peter Wijkstra, University Medical Center Groningen

Tracking Information
First Submitted Date  ICMJE September 6, 2019
First Posted Date  ICMJE September 13, 2019
Last Update Posted Date September 25, 2019
Estimated Study Start Date  ICMJE September 2019
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2019)
The validity of the respiratory volumes (tidal volume and minute volume), compared tot the pneumotachometer. [ Time Frame: 1 year ]
The validation of the ExSpiron© non-invasive monitor in patients diagnosed with ALS.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04089696 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2019)
  • The BORG RPE score (Ratings of Percieved Exertion) [ Time Frame: 1 year ]
    Visual analogue scale (VAS) score from 0-10, 0 is worse outcome, 10 is best outcome
  • The Amyotrophic lateral Sclerosis Assessment Questionnaire (ALSAQ-40) [ Time Frame: 1 year ]
    questionaire, score 0-4; 0 is never and 4 is alway or can not do.
  • SenTec is the name of a transcutaneous monitor [ Time Frame: 1 year ]
    Gas exchange during the night with the transcutaneous monitor SenTec©
  • The EMG [ Time Frame: 1 year ]
    Respiratory muscle activity and patient-ventilator asynchrony during the night and during NIV assessed with surface electromyograph
Original Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2019)
  • The BORG RPE score (Ratings of Percieved Exertion) [ Time Frame: 1 year ]
    Visual analogue scale (VAS) score
  • The Amyotrophic lateral Sclerosis Assessment Questionnaire (ALSAQ-40) [ Time Frame: 1 year ]
    questionaire
  • SenTec is the name of a transcutaneous monitor [ Time Frame: 1 year ]
    Gas exchange during the night with the transcutaneous monitor SenTec©
  • The EMG [ Time Frame: 1 year ]
    Respiratory muscle activity and patient-ventilator asynchrony during the night and during NIV assessed with surface electromyograph
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Validation of the "ExSpiron©" in Patients With ALS
Official Title  ICMJE Validation of the "Exspiron©" in Patients With Amyotrophic Lateral Sclerosis; Non-invasive Monitoring of Respiratory Volume.
Brief Summary

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

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Intervention study
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Amyotrophic Lateral Sclerosis
  • Neuromuscular Diseases
Intervention  ICMJE Device: ExSprion
The primary objective is the validation of the ExSpiron© non-invasive monitor in patients diagnosed with ALS.
Study Arms  ICMJE Experimental: ExSpiron
10 patients with ALS
Intervention: Device: ExSprion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 12, 2019)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04089696
Other Study ID Numbers  ICMJE UMCG
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Peter Wijkstra, University Medical Center Groningen
Study Sponsor  ICMJE University Medical Center Groningen
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Medical Center Groningen
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP