Validation Of Tidal/End -Tidal CO2 in ALS

NCT03764384 | Unknown

• 1 other identifier: P02366
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The study team propose that a new, hand-held test device may be valuable in the management of breathing failure in patients with Motor Neurone Disease (MND). The study team need to validate this device against the current gold standard of blood gas analysis and determine whether people with MND can use it at home. The new device, called 'N-Tidal C™' measures the carbon dioxide (CO2) in expired breath. At the end of the breath (end tidal) the CO2 level gives an indication of the CO2 in the person's arterial blood. Ventilatory failure is diagnosed at present using the value of CO2 in the arterial blood, but usually this can only be measured in specialist clinics. The study will determine if the end tidal CO2 measured by the new device agrees with CO2 measured on a blood test in clinic and also whether or not the device is practical for home use. The team will analyse the output of the device during home monitoring to see if changes in the pattern of CO2 in the expired breath identify, or even predict, the development of breathing failure in the community. With the results of these measures and detailed information about the patients in Papworth's clinic, recruited to this study, collected over a year the team will design a follow on study to see if using the new device at home can improve survival and quality of life for people with MND.

Conditions

Motor Neuron Disease; Amyotrophic Lateral Sclerosis

Keywords

PaCO2; N-Tidal C Device; Self-monitoring; CO2 waveforms

Outcome Measures

Primary Outcomes (1)

• The primary outcome of interest is the degree of agreement between end tidal CO2 measured by the N-Tidal CTM device and PaCO2 from arterial blood gas analysis.

  Arterial blood gas (measured in kPa) will be compared to the end tidal CO2 (kPa) measured from the N-Tidal CTM device. The measurements will be taken within 20 minutes of each other. The paired CO2 measures from N-Tidal CTM device and from ABG will be assessed for agreement. The results will be displayed graphically using a Bland Altman Plot and the mean difference, the standard deviation of the mean difference and confidence intervals for 95% limits of agreement will be reported.

  At each clinic visit through to study completion up to 24 months

Secondary Outcomes (2)

• Identify when an MND patient requires additional support with their breathing, in the form of starting NIV as derived from the CO2 measurement (kPA) and Respiratory Rate (RR) per minute from the N-Tidal CTM device.

  At each clinic visit through to study completion up to 24 months

• Identify when an MND patient develops a treatable respiratory condition, such as an infection as derived from the CO2 measurement (kPA) and Respiratory Rate (RR) per minute from the N-Tidal CTM device..

  At each clinic visit through to study completion up to 24 months

Other Outcomes (3)

• Any adverse events (AEs) reported during performing the study procedures

  At each clinic visit through to study completion up to 24 months

• Any adverse device events (ADEs

  At each clinic visit through to study completion up to 24 months

• Visual analogue scale (VAS) to record 'ease of use' of the N-Tidal C™ device during the study and at study completion

  At each clinic visit through to study completion up to 24 months

Study Arms (2)

Hospital Monitoring Group - ALSFRS-R cohort

All patients will be first recruited to this cohort unless at their first visit the investigator deems them eligible for the Home Monitoring Device Group. At the initial screening visit, all patients recruited into the study will undergo routine assessments according to the existing MND protocol, and additionally complete the ALSFRS-R symptom-based assessment questionnaire by interview with the study researchers (with assistance from spouse, family member or carer if required). Patients will continue to complete the ALSFRS-R symptom-based questionnaire at each clinic attendance.

Home Monitoring Cohort

If eligible patients will use the N Tidal CTM, up to 3 times a day (morning, midday and evening) throughout the home monitoring period until the final outpatient clinic visit. In addition subjects will complete a weekly diary symptom monitoring diary which asks them about their respiratory symptoms, GP attendances, respiratory infections. Patients routine standard of care assessments will also be documented according to the protocol as well as completing the ALSFRS-R at each visit.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will have previously been diagnosed with Motor Neurone Disease by a neurologist. Study participants will be recruited from patients attending weekly Motor Neurone Disease clinics within the RSSC at Royal Papworth Hospital.

You may qualify if:

• \- 1. Male or female with a diagnosis of definite or probable Motor Neurone Disease according to El Escorial criteria.
• \. Willing and able to provide informed consent.

You may not qualify if:

• Lung, chest wall, neuromuscular, cardiac or other comorbidity or abnormality that would markedly affect spirometry and/or other measures of lung function or TBCO2 measurements. To be judged by the CI.
• Tracheostomy in situ
• Not in ventilatory failure at the start of the study (PaCO2 \< 6.0 KPa)
• Sufficient manual dexterity and arm strength to use the device (or have a live-in carer/spouse/family member able to assist and willing to do so).
• Verified able to use the device (by trial with dummy device).
• Stated intention at the start of the study that they will accept NIV if they develop ventilatory failure.
• In the opinion of the clinical investigator, the participant would have difficulty completing the study procedures consistently.
• Established on NIV treatment

Sponsors & Collaborators

• Papworth Hospital NHS Foundation Trust: lead
• Motor Neurone Disease Association: collaborator
• Innovate UK: collaborator
• DOCATEF: collaborator
• TidalSense: collaborator

Study Sites (1)

Royal Papworth NHS Foundation Trust

Papworth Everard, Cambridge, CB23 3RE, United Kingdom

Location

Related Publications (5)

• Bourke SC, Tomlinson M, Williams TL, Bullock RE, Shaw PJ, Gibson GJ. Effects of non-invasive ventilation on survival and quality of life in patients with amyotrophic lateral sclerosis: a randomised controlled trial. Lancet Neurol. 2006 Feb;5(2):140-7. doi: 10.1016/S1474-4422(05)70326-4.

  PMID: 16426990 BACKGROUND

• COPD clinical trial : NIHRCRN 19599, ISRCTN 56492264

  BACKGROUND

• O'Neill CL, Williams TL, Peel ET, McDermott CJ, Shaw PJ, Gibson GJ, Bourke SC. Non-invasive ventilation in motor neuron disease: an update of current UK practice. J Neurol Neurosurg Psychiatry. 2012 Apr;83(4):371-6. doi: 10.1136/jnnp-2011-300480. Epub 2011 Aug 17.

  PMID: 21849339 BACKGROUND

• Checketts MR, Alladi R, Ferguson K, Gemmell L, Handy JM, Klein AA, Love NJ, Misra U, Morris C, Nathanson MH, Rodney GE, Verma R, Pandit JJ; Association of Anaesthetists of Great Britain and Ireland. Recommendations for standards of monitoring during anaesthesia and recovery 2015: Association of Anaesthetists of Great Britain and Ireland. Anaesthesia. 2016 Jan;71(1):85-93. doi: 10.1111/anae.13316. Epub 2015 Nov 19.

  PMID: 26582586 BACKGROUND

• Banerjee SK, Davies M, Sharples L, Smith I. The role of facemask spirometry in motor neuron disease. Thorax. 2013 Apr;68(4):385-6. doi: 10.1136/thoraxjnl-2012-201804. Epub 2012 Jul 27. No abstract available.

  PMID: 22843559 BACKGROUND

Related Links

• NICE guideline NG42: MND assessment and management
• 4\. NICE Technology Appraisal Guidance TA20 : Guidance on the use of Riluzole (Rilutek) for the treatment of Motor Neurone Disease

MeSH Terms

Conditions

Motor Neuron Disease; Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Neurodegenerative Diseases; Nervous System Diseases; Neuromuscular Diseases; Spinal Cord Diseases; Central Nervous System Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ian E Smith, MA MD F.R.C.P

  Royal Papworth NHS Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2018
• First Posted: December 5, 2018
• Study Start: August 20, 2018
• Primary Completion: June 4, 2021
• Study Completion: June 4, 2021
• Last Updated: March 10, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)