The Relationship Between Arterial Stiffness and Respiratory Failure in Motor Neurone Disease

NCT03444428 | Completed

• 1 other identifier: 210214 16/LO/1560
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 2

Brief Summary

• Patients with Motor Neurone Disease (MND) admitted to Lane Fox Unit /Royal Brompton Hospital and/or reviewed in Lane Fox Unit /Royal Brompton Hospital clinics and/or outreach review will be approached for participation in the study
• Physiological assessment and measurement of arterial stiffness will be performed in all patients at baseline and after the use of non invasive ventilation for 6 weeks.
• MND patients not requiring mechanical ventilation will serve as controls since non invasive ventilation cannot be withheld from MND patients in type II respiratory failure.
• Data will be analysed to look for differences between groups, relationships in baseline or change from baseline in respiratory physiological measures, inflammatory indices, breathlessness, and arterial stiffness.
• Age, Height, Weight
• History and Physical Examination
• Evaluation of dysponea: mMRC, Borg Scale (Seated-Supine)
• Amyotrophic lateral sclerosis functional rating scale (ALSFRS-R)
• Sleep Disordered Breathing in Neuromuscular Disease Questionnaire (SiNQ-5)
• 24 hour blood pressure monitor
• Carotid-femoral pulse wave velocity
• Respiratory Muscle Strength - Maximal Inspiratory Pressure, Maximal Expiratory Pressure, and Sniff Nasal Inspiratory Pressure
• Spirometry - FEV1 and FVC
• Arterial Blood Gas
• CRP and fibrinogen (clinically)
• Breathe CO exhale

Conditions

Motor Neurone Disease; Hypoxemia and/or Hypercapnia

Outcome Measures

Primary Outcomes (1)

• Comparing the pulse wave velocity between MND patients with hypoxemia and/or hypercapnia to those MND Patients that do not have hypoxemia and/or hypercapnia

  Is there a difference in pulse wave velocity between patients with MND who have and those who do not have hypoxemia and/or hypercapnia

  6 weeks

Secondary Outcomes (2)

• Comparison of pulse wave velocity values in MND patients to normal values

  6 weeks

• Comparison of pulse wave velocity pre-post non invasive ventilation in MND patients

  6 weeks

Study Arms (2)

Non Invasive Ventilation

* Age, height, weight * History and Physical Examination * Evaluation of dyspnoea: mMRC, Borg scale (Seated-Supine) * Amyotrophic lateral sclerosis functional rating scale (ALSFRS-R) * Sleep-Disordered Breathing in Neuromuscular Disease Questionnaire (SiNQ-5) * 24h Blood Pressure monitor * Spirometry - FEV1 and FVC * Respiratory muscle strength - MIP, MEP, and SNIP * Arterial Blood Gases * Carotid-femoral pulse wave velocity * Breath CO exhale

Other: Non Invasive Ventilation

Without Non Invasive Ventilation

Age, height, weight * History and Physical Examination * Evaluation of dyspnoea: mMRC, Borg scale (Seated-Supine) * Amyotrophic lateral sclerosis functional rating scale (ALSFRS-R) * Sleep-Disordered Breathing in Neuromuscular Disease Questionnaire (SiNQ-5) * 24h Blood Pressure monitor * Spirometry - FEV1 and FVC * Respiratory muscle strength - MIP, MEP, and SNIP * Arterial Blood Gases * Carotid-femoral pulse wave velocity * Breath CO exhale

Other: Without Non Invasive Ventilation

Interventions

Non Invasive Ventilation OTHER

Assessments for those participants who are being set up onto NIV

Non Invasive Ventilation

Without Non Invasive Ventilation OTHER

Assessments for those participants who are not being set up onto NIV

Without Non Invasive Ventilation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with Motor Neurone Disease

You may qualify if:

• MND diagnosis
• The ability to perform the respiratory function testing satisfactorily
• Stable clinical and functional state for at least four weeks before testing
• BMI 20-30 kg•m-2

You may not qualify if:

• Pregnancy
• Aged \<18, \>80
• Significant physical or psychiatric comorbidity that would prevent compliance with trial protocol
• Unstable clinical state
• Use of mechanical ventilation
• Cardiovascular disorders (history, physical examination)
• Known lung disease, such as asthma or COPD or any other cause of hypoxemia and/or hypercapnia but MND (history, physical examination, CXR review \[High Resolution Computed Tomography if CXR is not compatible with neuromuscular disease alone\])
• Airway obstruction (FEV1/FVC\<0.75)
• Diabetes mellitus
• Obesity (BMI\>30 kg•m-2)
• Smoking history (\>10 pack∙years or active smoker)

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

Study Sites (2)

Guys and St Thomas NHS Trust

London, SE1 7EH, United Kingdom

Location

Royal Brompton and Harefield NHS Trust

London, SW3 6NP, United Kingdom

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Patrick Murphy

  Guys and St Thomas NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2017
• First Posted: February 23, 2018
• Study Start: February 21, 2017
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: October 1, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)